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AzTrials

AmyloidosisPhase 1NCT03417830

Biodistribution of 89Zirconium-labelled GSK2398852 Using PET Imaging

A Phase 1 study testing GSK2315698 (CPHPC), GSK2398852 (unlabeled anti-SAP mAb) and 89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb) in people with Amyloidosis, run by GlaxoSmithKline at 1 site in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The principal aim of this study is to investigate the cardiac uptake of 89Zr-GSK2398852 in subjects with transthyretin cardiomyopathy amyloidosis (ATTR-CM), and its biodistribution to other organs. Low doses of GSK2398852 will be co-administered at levels not high enough for therapeutic benefit. Read more about this study

Who is it for?
Ages 65 to 80 years
Conditions the study is for
Amyloidosis
What is being tested?
GSK2315698 (CPHPC), GSK2398852 (unlabeled anti-SAP mAb) and 89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteSweden
Study dates
6 Apr 2018to 20 Jul 2018
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Subject must be 65 to 80 years of age inclusive, at the time of signing the informed consent.
  • Subjects with a diagnosis of ATTR-CM: a) Wild-type ATTR status must be confirmed by genotyping and have one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of Transthyretin amyloidosis (TTR) as the amyloid fibril protein either by immunohistochemistry or proteomic analysis OR ii) Scintigraphy Technetium-99m-labeled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD) with confirmed myocardial uptake. b) Hereditary ATTR amyloidosis (example, TTR Val30Met) should have a known amyloidogenic TTR mutation demonstrated by genotyping and is recognized to be primarily associated with cardiomyopathy and one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis. ii) Scintigraphy: 99mTc-DPD with confirmed myocardial uptake.
  • Both male and female subjects are eligible to participate. a) Male subjects: A male subject must agree to use contraception during the treatment period and for at least 3 months after the last scan and refrain from donating sperm during this period. b) Female subjects: A female subject is eligible to participate if she is not of childbearing potential.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.
  • New York Heart Association (NYHA) up to class 3; subjects should be clinically stable for at least 3 months preceding to Screening.

Who cannot join

  • Cardiomyopathy primarily caused by non-amyloid diseases (example, ischemic heart disease; valvular heart disease).
  • Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) >500 milliseconds (msec).
  • Sustained (at a rate of >=120 beats per minute for >=30 seconds), or symptomatic monomorphic ventricular tachycardia (VT), or rapid polymorphic VT, at Screening/Baseline cardiac monitoring.
  • Systolic blood pressure <=100 millimeters of mercury (mm/Hg) based on triplicate readings at Screening.
  • Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within 1 month of screening.
  • Implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM) at Screening.
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  • Estimated Glomerular filtration rate (eGFR) at Screening <50 milliliters per minute (mL/min) calculated using modification of diet in renal disease (MDRD).
  • Any active and persistent dermatological condition, which in the opinion of the Investigator and Medical Monitor would preclude safe participation.
  • History of allogeneic stem cell transplantation, prior solid organ transplant, or anticipated to undergo solid organ transplantation, or left ventricular assist device (LVAD) implantation.
  • Malignancy within last 5 years, except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been successfully treated.
  • Acute coronary syndrome, or any form of coronary revascularization procedure (including coronary artery bypass grafting [CABG]), within 6 months of screening.
  • Symptomatic, clinically significant autonomic neuropathy which the Principal Investigator (PI) feels will preclude administration of study treatment.
  • Uncontrolled hypertension during Screening.
  • ALT >3 times upper limit of normal (ULN) OR bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • Peripheral edema at Screening that in the opinion of the PI or designee might prevent adequate absorption of subcutaneously administered CPHPC.
  • Presence of any co-morbid (example, steroid refractory rheumatoid arthritis), or an uncontrolled medical condition (example, diabetes mellitus), which in the opinion of the investigator would increase the potential risk to the subject. Investigator should liaise with the Medical Monitor where there is uncertainty as to the eligibility of a subject.
  • Positive test for hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) during Screening, or within 3 months prior to first dose of study treatment.
  • Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis and exfoliative dermatitis).
  • Inability to comprehend and/or understand the study patient information sheet, and/or unwillingness or inability to follow the procedures outlined in the protocol.
  • Has any of the following: a) Fulfillment of diagnostic criteria for Amyloid Light-chain (AL) amyloidosis. b) Fulfillment of diagnostic criteria for amyloid A (AA) or non-TTR hereditary amyloidosis.
  • ATTR Disease Load: c) Histologically proven or clinically suspected gastrointestinal TTR amyloidosis; d) Diffuse skeletal muscle uptake of 99m(Tc)-DPD on Single-photon emission computed tomography (SPECT) imaging (where available); e) Peripheral neuropathy causing more than mild morbidity (example, walking disability; neuropathic pain affecting activities of daily living); f) Proven or clinically suspected intracranial TTR involvement including ophthalmological disease.
  • Non-amyloidosis related chronic liver disease (with the exception of Gilbert's syndrome or clinically asymptomatic gallstones).
  • Participation in a separate clinical trial involving CPHPC within 3 months of Screening.
  • Any prohibited concomitant medication within referenced timeframe.
  • Treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of the study agent, whichever is longer.
  • Orthopnea of sufficient severity to preclude supine scanning as determined at Screening.
  • Inability to fit inside scanner due to body size (girth).
  • History of claustrophobia.
  • Contraindication to magnetic resonance imaging (MRI) contrast agents.
  • Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to: a) Intracranial aneurysm clips (except Sugita) or other metallic objects; b) Intra-orbital metal fragments that have not been removed; c) Pacemakers or other implanted cardiac rhythm management/monitoring devices and non-magnetic resonance (MR) conditional heart valves; d) Inner ear implants.
  • Donation of blood or blood products in excess of 500 milliliters (mL) within 84 days of Screening.
  • Poor or unsuitable venous access.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • GSK Investigational Site

    Uppsala, SE-751 85

Other trials in Sweden

About this study

Official title: An Adaptive, Open-Label Study to Evaluate the Biodistribution of 89Zirconium-labelled GSK2398852 in the Heart and Other Organs of Patients With Transthyretin Cardiomyopathy (ATTR-CM) Using Positron Emission Tomography (PET) Imaging

The principal aim of this study is to investigate the cardiac uptake of 89Zr-GSK2398852 in subjects with transthyretin cardiomyopathy amyloidosis (ATTR-CM), and its biodistribution to other organs. Low doses of GSK2398852 will be co-administered at levels not high enough for therapeutic benefit. This study will be conducted in two parts: Part A and Part B. Subjects in Part A will participate in up to two dosing sessions and subjects in Part B will participate in one dosing session. Subjects will undergo up to 3 PET scans at varying intervals after 89Zr-GSK2398852 administration. The total duration of study will be approximately 3 to 4 months for subjects in Part A and approximately 2 months for subjects in Part B. Part B of the study will be triggered based on data obtained in Part A and other emerging data.

Conditions
Amyloidosis
Being tested
GSK2315698 (CPHPC), GSK2398852 (unlabeled anti-SAP mAb), 89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)
Keywords
miridesap, GSK2315698, 89Zirconium labelled, Positron Emission Tomography, Transthyretin cardiomyopathy, GSK2398852, dezamizumab
Medical subject headings
Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK2315698 (CPHPC)Drug

    Also called miridesap

    GSK2315698 will be administered as 20 milligrams per hour (20 mg/hour) IV infusion (in the vein) for up to 72 hours followed by 60 milligrams (mg) three times daily as SC injection for 8 days. Dose level and frequency will be adjusted according to renal function.

  • GSK2398852 (unlabeled anti-SAP mAb)Drug

    Also called dezamizumab

    Subjects will be administered up to 490 mg of GSK2398852, IV. Dose level will be adjusted based on emerging imaging data.

  • 89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)Drug

    89Zr-GSK2398852 will be available as solution containing 10 mg 89Zr-GSK2398852 for Infusion. Subjects will be administered 37 (Megabecquerel) MBq radioactive dose of 89Zr-GSK2398852 by the IV route at each dosing session.

Study groups in NCT03417830
Study groupRoleWhat they receive
Subjects with ATTR-CM in Part AExperimentalApproximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part A will participate in two anti-SAP dosing sessions approximately 26 days in duration. The first two subjects in Part A will have up to three 89Zr PET scans, while the remaining subject will undergo up to two 89Zr PET scans.
Receives: Drug: GSK2315698 (CPHPC); Drug: GSK2398852 (unlabeled anti-SAP mAb); Drug: 89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)
Subjects with ATTR-CM in Part BExperimentalApproximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part B will participate in one anti-SAP dosing session. Subjects will undergo up to two 89Zr PET scans.
Receives: Drug: GSK2315698 (CPHPC); Drug: GSK2398852 (unlabeled anti-SAP mAb); Drug: 89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A- Session 1: Peak Standardized Uptake Values (SUV) in Focal Anatomical Regions of the Heart Following 80-200 mg Dose of Anti-SAP mAb

    SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as blood pool left atrium, blood pool left ventricle, blood pool right ventricle, left ventricle wall - high uptake, left ventricle wall - low uptake, mid septum - high uptake and mid septum - low uptake. Peak SUV values derived from PET images has been presented. All treated population consisted of all participants who received at least one Anti-SAP treatment including 89Zr-GSK2398852.

    Measured: Session 1: Days 4, 5, 6 and 8

  2. Part A- Session 2: Peak SUV in Focal Anatomical Regions of the Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg

    SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as blood pool left atrium, blood pool left ventricle, blood pool right ventricle, left ventricle wall - high uptake, left ventricle wall - low uptake, mid septum - high uptake and mid septum - low uptake. Peak SUV values derived from PET images has been presented.

    Measured: Session 2: Days 3, 4 and 5

  3. Part B: Peak SUV in Focal Anatomical Regions of the Heart Following 80-200 mg Dose of Anti-SAP mAb

    SUV in focal anatomical regions of the heart was planned to be measured.

    Measured: Days 3, 4 and 6

  4. Part B: Peak SUV in Focal Anatomical Regions of the Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg

    SUV in focal anatomical regions of the heart was planned to be measured.

    Measured: Days 3, 4 and 6

  5. Part A- Session 1: Mean SUV of Whole Heart Following 80-200 mg Dose of Anti-SAP mAb

    SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.

    Measured: Session 1: Days 4, 5, 6 and 8

  6. Part A- Session 2: Mean SUV of Whole Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg

    SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.

    Measured: Session 2: Days 3, 4 and 5

  7. Part B: Mean SUV of Whole Heart Following 80-200 mg Dose of Anti-SAP mAb

    SUV of whole heart was planned to be measured.

    Measured: Days 3, 4 and 6

  8. Part B: Mean SUV of Whole Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg

    SUV of whole heart was planned to be measured.

    Measured: Days 3, 4 and 6

Secondary outcomes (83)

  1. Part A- Session 1: Mean SUV of Focal Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb

    SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as abdominal skin and skin of the back. Mean SUV derived from PET images has been presented.

    Measured: Session 1: Days 4, 5, 6 and 8

  2. Part A- Session 1: Mean SUV of Focal Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb: Thyriod Gland-goitre Hotspot

    SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for thyroid gland-goitre hotspot. Mean SUV derived from PET images has been presented.

    Measured: Session 1: Days 4 and 6

  3. Part A- Session 2: Mean SUV of Focal Radioactivity Uptake After Anti-SAP mAb Dose Between 200 mg and <=500 mg

    SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as thyroid gland-goitre hotspot, abdominal skin and skin of the back. Mean SUV derived from PET images has been presented.

    Measured: Session 2: Days 3, 4 and 5

  4. Part B: Mean SUV of Focal Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb

    SUV of focal radioactivity uptake for different organs/tissues was planned to be measured.

    Measured: Days 3, 4 and 6

  5. Part B: Mean SUV of Focal Radioactivity Uptake After Anti-SAP mAb Dose Between 200 mg and <=500 mg

    SUV of focal radioactivity uptake for different organs/tissues was planned to be measured.

    Measured: Days 3, 4 and 6

  6. Part A- Session 1: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb

    SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as adrenal gland, aorta, bone marrow, kidney, liver, spleen, abdominal region, brain, lung, parotid gland, and thigh. Mean SUV derived from PET images has been presented.

    Measured: Session 1: Days 4, 5, 6 and 8

  7. Part A- Session 1: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb: Thyroid Gland-goitre

    SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for thyroid gland-goitre. Mean SUV derived from PET images has been presented.

    Measured: Session 1: Days 4 and 6

  8. Part A- Session 1: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb: Testes

    SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for testes. Mean SUV derived from PET images has been presented.

    Measured: Session 1: Days 4, 5 and 8

  9. Part A- Session 2: Mean SUV of Total Radioactivity Uptake After Anti-SAP mAb Dose Between 200 mg and <=500 mg

    SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as adrenal gland, aorta, bone marrow, kidney, liver, spleen, abdominal region, brain, lung, parotid gland, thigh, and thyroid gland- goitre. Mean SUV derived from PET images has been presented.

    Measured: Session 2: Days 3, 4, and 5

  10. Part B: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb

    SUV of total radioactivity uptake for different organs/tissues was planned to be measured.

    Measured: Days 3, 4 and 6

  11. Part B: Mean SUV of Total Radioactivity Uptake After an Anti-SAP mAb Dose Between 200 mg and <=500 mg

    SUV of total radioactivity uptake for different organs/tissues was planned to be measured.

    Measured: Days 3, 4 and 6

  12. Part A: Maximum Concentration in Plasma (Cmax) of Total mAb

    Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). PK Population consisted of all participants from the All Treated Population for whom a PK sample was obtained and analyzed.

    Measured: Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7

  13. Part B: Cmax of Total mAb

    Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.

    Measured: Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8

  14. Part A: Time Associated With Cmax (Tmax) of Total mAb

    Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).

    Measured: Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7

  15. Part B: Tmax of Total mAb

    Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.

    Measured: Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8

  16. Part A: Clearance of Total mAb

    Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).

    Measured: Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7

  17. Part B: Clearance of Total mAb

    Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.

    Measured: Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8

  18. Part A: Terminal Half-life (T1/2) of Total mAb

    Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).

    Measured: Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7

  19. Part B: T1/2 of Total mAb

    Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.

    Measured: Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8

  20. Part A:Area Under the Concentration Time Curve Till Last Observation (AUC[0 to t]) of Total mAb

    Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).

    Measured: Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7

  21. Part B: AUC(0 to t) of Total mAb

    Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.

    Measured: Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8

  22. Part A: Area Under the Concentration Time Curve Till Time Infinity (AUC[0 to Infinity]) of Total mAb

    Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).

    Measured: Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7

  23. Part B: AUC(0 to Infinity) of Total mAb

    Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.

    Measured: Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8

  24. Part A: Cmax of 89Zr-GSK2398852 PKs of Radioactivity (Radio-PK)

    Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.

    Measured: Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6

  25. Part B: Cmax of 89Zr-GSK2398852 Radio-PK

    Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.

    Measured: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6

  26. Part A: Tmax of 89Zr- GSK2398852 Radio-PK

    Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.

    Measured: Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6

  27. Part B: Tmax of 89Zr-GSK2398852 Radio-PK

    Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.

    Measured: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6

  28. Part A: T1/2 of 89Zr- GSK2398852 Radio-PK

    Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.

    Measured: Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6

  29. Part B: T1/2 of 89Zr- GSK2398852 Radio-PK

    Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.

    Measured: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6

  30. Part A: AUC(0 to t) of 89Zr- GSK2398852 Radio-PK

    Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.

    Measured: Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6

  31. Part B: AUC(0 to t) of 89Zr- GSK2398852 Radio-PK

    Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.

    Measured: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6

  32. Part A: AUC(0 to Infinity) of 89Zr- GSK2398852 Radio-PK

    Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.

    Measured: Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6

  33. Part B: AUC(0 to Infinity) of 89Zr- GSK2398852 Radio-PK

    Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.

    Measured: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6

  34. Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least one dose of GSK2315698, GSK2398852 or 89Zr-GSK2398852.

    Measured: Up to Day 26 of the last session

  35. Part B: Number of Participants With AEs and SAEs

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention.

    Measured: Up to Day 26

  36. Part A: Number of Participants With Skin Rashes

    Rash was graded as Grade 1 to Grade 4 based on symptoms and body surface area (BSA) affected; Grade 1: <10 percent (%) BSA and asymptomatic; Grade 2: 10-30% BSA and/or mild symptoms (pain, itch and burning); Grade 3: >30% BSA and/or moderate/severe symptoms (pain, itch and burning); and Grade 4: any rash with mucosal or systemic involvement (such as evidence of renal involvement).

    Measured: Up to Day 26 of the last session

  37. Part B: Number of Participants With Skin Rashes

    Rash was planned to be graded as Grade 1 to Grade 4 based on symptoms and BSA affected; Grade 1: <10% BSA and asymptomatic; Grade 2: 10-30% BSA and/or mild symptoms (pain, itch and burning); Grade 3: >30% BSA and/or moderate/severe symptoms (pain, itch and burning); and Grade 4: any rash with mucosal or systemic involvement (such as evidence of renal involvement).

    Measured: Up to Day 26

  38. Part A: Number of Participants With Cardiac Adverse Events

    The number of participants with any cardiovascular AEs i.e. any AE coded to the cardiovascular system organ class are presented.

    Measured: Up to Day 26 of the last session

  39. Part B: Number of Participants With Cardiac Adverse Events

    The number of participants with any cardiovascular AEs i.e. any AE coded to the cardiovascular system organ class were planned to be reported.

    Measured: Up to Day 26

  40. Part A: Number of Participants With Infusion Related Reactions

    Number of participants with any infusion related reactions are presented.

    Measured: Up to Day 26 of the last session

  41. Part B: Number of Participants With Infusion Related Reactions

    Number of participants with any infusion related reactions were planned to be reported.

    Measured: Up to Day 26

  42. Part A: Change From Baseline in Cardiac Troponin T and N-terminal Prohormone of Brain Natriuretic Peptide (NT-ProBNP)

    Blood samples were collected to analyze the troponin T and NT-ProBNP at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Session 1: Baseline (Day 1 Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 26; Session 2: Day 1- Pre-dose, Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 26

  43. Part B: Change From Baseline in Cardiac Troponin T and NT-ProBNP

    Blood samples were planned to be collected to analyze the troponin T and NT-ProBNP at indicated time points. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Baseline and up to Day 26

  44. Part A: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings

    12-lead ECGs were measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

    Measured: Up to Day 26 of the last session

  45. Part B: Number of Participants With Abnormal 12-lead ECG Findings

    12-lead ECGs were planned to be measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant.

    Measured: Up to Day 26

  46. Part A: Number of Participants With Abnormal Inpatient Cardiac Telemetry

    Continuous inpatient cardiac monitoring was performed via remote cardiac telemetry device. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

    Measured: Up to Day 26 of the last session

  47. Part B: Number of Participants With Abnormal Inpatient Cardiac Telemetry

    Continuous inpatient cardiac monitoring was planned to be performed via remote cardiac telemetry device.

    Measured: Up to Day 26

  48. Part A: Number of Participants With Abnormal Outpatient Cardiac Telemetry

    Continuous outpatient cardiac monitoring was performed via remote cardiac bodyguardian telemetry device. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

    Measured: Up to Day 26 of the last session

  49. Part B: Number of Participants With Abnormal Outpatient Cardiac Telemetry

    Continuous outpatient cardiac monitoring was planned to be performed via remote cardiac bodyguardian telemetry device.

    Measured: Up to Day 26

  50. Part A: Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Potential Clinical Importance (PCI) ranges for the SBP and DBP were as follows: SBP- <90 and >180 millimeters of mercury (mmHg), and DBP- <30 and >110 mmHg.

    Measured: Up to Day 26 of the last session

  51. Part B: Number of Participants With Abnormal SBP and DBP

    SBP and DBP were planned to be measured in a semi-supine position after 5 minutes of rest for the participant.

    Measured: Up to Day 26

  52. Part A: Number of Participants With Abnormal Temperature

    Temperature was measured in a semi-supine position after 5 minutes of rest for the participant. Normal range for temperature was as follows: temperature- >37.5 degree celsius.

    Measured: Up to Day 26 of the last session

  53. Part B: Number of Participants With Abnormal Temperature

    Temperature was planned to be measured in a semi-supine position after 5 minutes of rest for the participant.

    Measured: Up to Day 26

  54. Part A: Number of Participants With Abnormal Respiratory Rate

    Respiratory rate was measured in a semi-supine position after 5 minutes of rest for the participant. Normal range for the respiratory rate was as follows: respiratory rate- <12 and >25 breaths per minute.

    Measured: Up to Day 26 of the last session

  55. Part B: Number of Participants With Abnormal Respiratory Rate

    Respiratory rate was planned to be measured in a semi-supine position after 5 minutes of rest for the participant.

    Measured: Up to Day 26

  56. Part A: Number of Participants With Abnormal Pulse Rate

    Pulse rate were measured in a semi-supine position after 5 minutes of rest for the participant. PCI range for the pulse rate was as follows: pulse rate- <35 and >140 beats per minute (bpm).

    Measured: Up to Day 26 of the last session

  57. Part B: Number of Participants With Abnormal Pulse Rate

    Pulse rate was planned to be measured in a semi-supine position after 5 minutes of rest for the participant.

    Measured: Up to Day 26

  58. Part A: Number of Participants With New Abnormal Physical Examination Findings

    A full and brief physical examination was performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen).

    Measured: Session 1: At screening (within 35 days of Anti-SAP treatment of session 1), Day 1 Pre-dose, Day 3, Day 5, Day 8 and Day 11; Session 2: Day 1 Pre-dose, Day 3, Day 5, Day 8 and Day 11

  59. Part B: Number of Participants With New Abnormal Physical Examination Findings

    A full and brief physical examination was planned to be performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen).

    Measured: At screening (within 35 days of Anti-SAP treatment), Days 1, 3, 5, 8 and 11

  60. Part A: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets

    Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1-Pre-dose, Days 3, 5, 7, 10 and 26

  61. Part B: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets

    Blood samples were planned to be collected to analyze the hematology parameters.

    Measured: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26

  62. Part A: Change From Baseline in Hematology Parameter: Hematocrit

    Blood samples were collected to analyze the hematology parameter: Hematocrit. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1-Pre-dose, Days 3, 5, 7, 10 and 26

  63. Part B: Change From Baseline in Hematology Parameter: Hematocrit

    Blood samples were planned to be collected to analyze the hematology parameter.

    Measured: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26

  64. Part A: Change From Baseline in Hematology Parameter: Hemoglobin

    Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26

  65. Part B: Change From Baseline in Hematology Parameter: Hemoglobin

    Blood samples were planned to be collected to analyze the hematology parameter.

    Measured: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26

  66. Part A: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin

    Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26

  67. Part B: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin

    Blood samples were planned to be collected to analyze the hematology parameter.

    Measured: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26

  68. Part A: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume

    Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26

  69. Part B: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume

    Blood samples were planned to be collected to analyze the hematology parameter.

    Measured: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26

  70. Part A: Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes

    Blood samples were collected to analyze the hematology parameters: Erythrocytes and Reticulocytes. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26

  71. Part B: Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes

    Blood samples were planned to be collected to analyze the hematology parameters.

    Measured: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26

  72. Part A: Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea

    Blood samples were collected to analyze the chemistry parameters: Glucose, Calcium, Potassium, Sodium and Urea. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26

  73. Part B: Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea

    Blood samples were planned to be collected to analyze the chemistry parameters.

    Measured: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26

  74. Part A: Change From Baseline in Chemistry Parameters: Albumin, Protein

    Blood samples were collected to analyze the chemistry parameters: Albumin and Protein. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26

  75. Part B: Change From Baseline in Chemistry Parameters: Albumin, Protein

    Blood samples were planned to be collected to analyze the chemistry parameters.

    Measured: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26

  76. Part A: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST)

    Blood samples were collected to analyze the chemistry parameters: ALP, ALT and AST. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26

  77. Part B: Change From Baseline in Chemistry Parameters: ALP, ALT, AST

    Blood samples were planned to be collected to analyze the chemistry parameters.

    Measured: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26

  78. Part A: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine

    Blood samples were collected to analyze the chemistry parameters: Direct Bilirubin, Bilirubin, Creatinine. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26

  79. Part B: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine

    Blood samples were planned to be collected to analyze the chemistry parameters.

    Measured: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26

  80. Part A: Number of Participants With Abnormal Urinalysis Parameters: Glucose, Protein, Blood, Ketones

    Urine samples were collected to analyze urinalysis parameters including glucose, protein, blood and ketones.

    Measured: Up to Day 26 of the last session

  81. Part A: Number of Participants With Abnormal Urinalysis Parameters: Specific Gravity, Potential of Hydrogen

    Urine samples were collected to analyze urinalysis parameters including specific gravity and potential of hydrogen.

    Measured: Up to Day 26 of the last session

  82. Part B: Number of Participants With Abnormal Urinalysis Parameters: Glucose, Protein, Blood, Ketones

    Urine samples were planned to be collected to analyze the urinalysis parameters.

    Measured: Up to Day 26

  83. Part B: Number of Participants With Abnormal Urinalysis Parameters: Specific Gravity, Potential of Hydrogen

    Urine samples were planned to be collected to analyze the urinalysis parameters.

    Measured: Up to Day 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2018
  2. Study start6 Apr 2018
  3. Primary completion20 Jul 2018
  4. Study completion20 Jul 2018

Why it stopped: Change in benefit/risk profile.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Sequential
Model description
Part A of the study will include 3 subjects with ATTR-CM who will participate in two dosing sessions and Part B of the study will include 3 subjects with ATTR-CM who will participate in one dosing session. A single dosing session will constitute treatment with carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC), total mass dose (TMD) administration of anti-serum amyloid P (SAP) monoclonal antibody (mAb) consisting of in vivo mixing of a single infusion of unlabeled anti-SAP mAb and a separate infusion of 89Zr-GSK2398852 via a different peripheral venous line, and up to 3 serial PET scanning procedures after administration of 89Zr-GSK2398852.
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03417830
Sponsor's protocol ID
204512
Other IDs
2017-002665-22, 2017
Status last verified
Jul 2019
First submitted
25 Jan 2018
Last updated
29 Aug 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Wechalekar A, Antoni G, Al Azzam W, Bergstrom M, Biswas S, Chen C, Cheriyan J, Cleveland M, Cookson L, Galette P, Janiczek RL, Kwong RY, Lukas MA, Millns H, Richards D, Schneider I, Solomon SD, Sorensen J, Storey J, Thompson D, van Dongen G, Vugts DJ, Wall A, Wikstrom G, Falk RH. Pharmacodynamic evaluation and safety assessment of treatment with antibodies to serum amyloid P component in patients with cardiac amyloidosis: an open-label Phase 2 study and an adjunctive immuno-PET imaging study. BMC Cardiovasc Disord. 2022 Feb 13;22(1):49. doi: 10.1186/s12872-021-02407-6.

    PubMed 35152886

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK2315698 (CPHPC), GSK2398852 (unlabeled anti-SAP mAb) and 89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb) in people with Amyloidosis, run by GlaxoSmithKline at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A- Session 1: Peak Standardized Uptake Values (SUV) in Focal Anatomical Regions of the Heart Following 80-200 mg Dose of Anti-SAP mAb (time frame: Session 1: Days 4, 5, 6 and 8). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03417830, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.

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