AmyloidosisPhase 1NCT01406314
SAP Depleter Dose Assessment Study in Patients
A Phase 1 study testing GSK2315698 in people with Amyloidosis, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This study aims to provide safety information on the ligand, GSK2315698A. The pharmacokinetics and pharmacodynamics of the ligand will be determined together with the differences in routes of dose administration, namely the tolerability between intravenous versus subcutaneous dose administration. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyloidosis
- What is being tested?
- GSK2315698
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Oct 2011to 14 Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medically diagnosed with systemic amyloidosis
- AST,ALT, alkaline phosphatase <= 3xULN and bilirubin ,1.5xULN
- undergone radio-labelled-SAP scanning as part of their routine clinical care
- male or female between 18 and 80 years of age inclusive, at time of signing the informed consent
- subject is ambulant and capable of attending CUC
- capable of giving written consent, which includes compliance with the requirements of the requirement and restrictions listed in the consent form
Show all 9Show fewer
- a female subjects is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
- male subjects with female partners of child-bearing potential must agree to use contraception methods listed in the protocol and informed consent information. This must be followed from the time of the first dose of study medication to 85 days post-last dose.
- smokers (<10 cigarettes a day) are permitted but must be willing to abstain for the duration of residential study sessions
Who cannot join
- a positive pre-study Hepatitis B surface antigen or Hepatitis C antibody result within 3 months of screening
- the subject has participated in a clinical trial and has received an investigational therapeutic product (unlicensed) within 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
- pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing
- lactating females
- unwillingness or inability to follow the procedures outlined in the protocol
- subject is mentally or legally incapacitated
Show all 14Show fewer
- renal failure requiring haemodialysis will normally result in exclusion. Subjects in patient group 4 on haemodyalysis may be considered providing their schedule of dialysis can be accommodated within the study schedule
- decompensated cardiac failure or recent history of syncope
- clinically significant anaemia - Hb<9g/dL
- use of prohibited medications
- poor or unsuitable venous access
- subjects with a QTc of > or equal to 480ms or other ECG abnormalities which, in the opinion of the investigator, is clinically significant in that they may increase safety risk
- uncontrolled hypertension with systolic BP> 170mm Hg and/or diastolic >100 mm Hg
- previous surgical procedures that result in altered anatomy of the upper digestive tract including cholecystectomy (gall bladder removal) will result in exclusion from the Entero-Test procedure, but the subject may still participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open Label, Dose Characteristic Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Intravenous and Subcutaneous Doses of GSK2315698A in Patients With Systemic Amyloidosis
This study aims to provide safety information on the ligand, GSK2315698A. The pharmacokinetics and pharmacodynamics of the ligand will be determined together with the differences in routes of dose administration, namely the tolerability between intravenous versus subcutaneous dose administration. The study will be carried out in patients with systemic amyloidosis and the ability of GSK2315698A in depleting levels of serum amyloid protein (SAP) will be measured.
Read the detailed description
This study is an open label, dose characteristic study assessing safety and pharmacokinetic and pharmacodynamic considerations of GSK2315698A. GSK2315698A is a ligand known to bind to serum amyloid protein (SAP), a key component of an anti-SAP approach to the treatment of systemic amyloidosis. Safety assessments will include adverse events, vital signs, ECGs and other relevant clinical laboratory tests. Dose administration routes will also be determined focusing on the tolerability of intravenous dose administration versus subcutaneous. The study aims to recruit up to 30 patients with a medical diagnosis of systemic amyloidosis. Subjects will be asked to attend 2 dosing sessions, each session will involve an intravenous infusion of GSK2315698A over 48 hours followed by a single subcutaneous dose in session 1 and up to 3 subcutaneous doses in session 2 to be administered over a 24 hour period.
- Conditions
- Amyloidosis
- Being tested
- GSK2315698
- Keywords
- Phase 1, Patient, Systemic Amyloidosis, Amyloidosis
- Medical subject headings
- Amyloidosis, Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2315698Drug
Intravenous infusion for approximately 48hours followed by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intravenous infusion for approximately 48 hours followed by subcutaneous injection Receives: Drug: GSK2315698 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentrations of SAP
comparison of predicted vs observed
Measured: 19 weeks
Plasma concentrations of GSK2315698
changes in plasma concentrations of GSK2315698 over time
Measured: 19 weeks
Secondary outcomes (2)
safety and tolerability of GSK2315698
evaluated by adverse event (AE) reporting, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG).
Measured: 19 weeks
Change from baseline in blood SAP levels
evaluate effect of GSK2315698 on SAP levels in the blood
Measured: 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study start13 Oct 2011
- Primary completion14 Nov 2012
- Study completion14 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406314
- Sponsor's protocol ID
- 114527
- Status last verified
- Jun 2017
- First submitted
- 26 Jul 2011
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Dose Characteristic Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Intravenous and Subcutaneous Doses of GSK2315698A in Patients With Systemic Amyloidosis
- ClinicalTrials.gov ID
- NCT01406314
- Acronym / sponsor ID
- 114527
- Conditions
- Amyloidosis
- Keywords
- Phase 1, Patient, Systemic Amyloidosis, Amyloidosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2011 (actual)
- Primary completion
- 14 Nov 2012 (actual)
- Study completion
- 14 Nov 2012 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to provide safety information on the ligand, GSK2315698A. The pharmacokinetics and pharmacodynamics of the ligand will be determined together with the differences in routes of dose administration, namely the tolerability between intravenous versus subcutaneous dose administration. The study will be carried out in patients with systemic amyloidosis and the ability of GSK2315698A in depleting levels of serum amyloid protein (SAP) will be measured.
Detailed description
This study is an open label, dose characteristic study assessing safety and pharmacokinetic and pharmacodynamic considerations of GSK2315698A. GSK2315698A is a ligand known to bind to serum amyloid protein (SAP), a key component of an anti-SAP approach to the treatment of systemic amyloidosis. Safety assessments will include adverse events, vital signs, ECGs and other relevant clinical laboratory tests. Dose administration routes will also be determined focusing on the tolerability of intravenous dose administration versus subcutaneous. The study aims to recruit up to 30 patients with a medical diagnosis of systemic amyloidosis. Subjects will be asked to attend 2 dosing sessions, each session will involve an intravenous infusion of GSK2315698A over 48 hours followed by a single subcutaneous dose in session 1 and up to 3 subcutaneous doses in session 2 to be administered over a 24 hour period.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: GSK2315698Intravenous infusion for approximately 48 hours followed by subcutaneous injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- medically diagnosed with systemic amyloidosis
- AST,ALT, alkaline phosphatase <= 3xULN and bilirubin ,1.5xULN
- undergone radio-labelled-SAP scanning as part of their routine clinical care
- male or female between 18 and 80 years of age inclusive, at time of signing the informed consent
- subject is ambulant and capable of attending CUC
Key exclusion criteria (14 listed)
- a positive pre-study Hepatitis B surface antigen or Hepatitis C antibody result within 3 months of screening
- the subject has participated in a clinical trial and has received an investigational therapeutic product (unlicensed) within 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
- pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing
- lactating females
- unwillingness or inability to follow the procedures outlined in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK2315698Intravenous infusion for approximately 48hours followed by subcutaneous injection | Drug | Intervention |
Primary outcome
Blood concentrations of SAP
Time frame: 19 weeks
comparison of predicted vs observed
Plasma concentrations of GSK2315698
Time frame: 19 weeks
changes in plasma concentrations of GSK2315698 over time
2 secondary outcomes
safety and tolerability of GSK2315698
Time frame: 19 weeks
Change from baseline in blood SAP levels
Time frame: 19 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Results for study 114527 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Related trials for Amyloidosis
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Recruiting
Longitudinal Quantitative Neuromuscular MRI in Neuropathic Patients
Charcot-Marie-Tooth Neuropathy Type 1A, Hereditary Transthyretin Amyloid Neuropathy
Not yet recruitingObservational study
PET/CT Imaging in Carriers of TTR Mutations
ATTR, ATTR Gene Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK2315698 in people with Amyloidosis, run by GlaxoSmithKline at 1 site in United Kingdom.
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 9 inclusion and 14 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: finished, as of the sponsor's last update on 9 Jun 2017. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood concentrations of SAP (time frame: 19 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2017.