Hepatic ImpairmentPhase 1NCT02571816
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215
A Phase 1 study testing ASP2215 in people with Hepatic Impairment and Healthy, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in subjects with mild and moderate hepatic impairment to matched healthy subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy
- What is being tested?
- ASP2215
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2015to 5 Mar 2016
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A prospective subject is eligible for the clinical study if all of the following apply:
- Subject has a Body Mass Index (BMI) range of 18.5 - 34.0 kg/m2, inclusive and weighs at least 50 kg at screening.
- Female subject must be nonchildbearing potential;
- Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
- Documented surgically sterile (at least 1 month prior to screening), and
- Female subject must have a negative pregnancy test at screening and Day -1.
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- Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 45 days after the final study drug administration.
- Female subject must not donate ova starting at screening and throughout the study period and for 45 days after the final study drug administration.
- Male subject and their female spouse/partners who are of childbearing potential must be using 2 forms of highly effective birth control (1 of which must be a barrier method) starting at screening and continue throughout the study period and for 105 days after the final study drug administration.
- Male subject must not donate sperm starting at screening and throughout the study period and for 105 days after the final study drug administration.
- Subject agrees not to participate in another interventional study while participating in the present study, defined as signing the informed consent form until completion of the last study visit.
- In addition, subjects with mild or moderate hepatic impairment must also meet the following inclusion criterion:
- Subject must have a Child-Pugh classification Class A (mild, 5 to 6 points) or Class B (moderate, 7 to 9 points) liver function impairment at screening.
Who cannot join
- A prospective subject will be excluded from participation in this clinical study if any of the following apply:
- Female subject who has been pregnant within 6 months prior to screening assessment or breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to ASP2215, or any components of the formulation used.
- Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies prior to study drug administration).
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to day -1.
- Subject has a long QT interval (QTc) at baseline
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- Subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or long corrected QT interval (QTc) syndrome or family history of long QTc syndrome
- Subjects with hypokalemia and hypomagnesemia at screening (defined as values below lower limit of normal).
- Subject has a mean pulse < 40 or > 90 bpm; mean systolic blood pressure (SBP) >160 mmHg; mean diastolic blood pressure (DBP) >100 mmHg (measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse will be measured automatically) at day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate can be taken.
- Subject who has received the following drugs/products within 2 weeks prior to dosing:
- Strong or moderate inhibitors (e.g., ketoconazole or fluconazole) or inducers (e.g., rifampin or phenytoin) of cytochrome P450 (CYP)3A4
- Inhibitors and inducers of P-glycoprotein (P-gp)
- Substrates of multidrug and toxin extrusion (MATE) 1
- Drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5 hydroxytryptamine receptor 2B (5HT2BR)
- Subject has a history of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit.
- Subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor) or the subject tests positive for alcohol or drugs of abuse at screening or day -1 (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates).
- Subject has used any drugs of abuse within 3 months prior to admission to the clinical unit.
- Subject anticipates an inability to abstain from xanthine (e.g., caffeine), grapefruit, Seville oranges (including marmalade), star fruit or any products containing these items from 72 hours prior to day -1 and throughout the duration of the study.
- Subject has significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to day -1.
- Subject has participated in any clinical study or has been treated with any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening.
- Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation.
- Subject is an employee of the Astellas Group or Contract Research Organization.
- In addition, healthy subjects must also NOT meet the following exclusion criteria:
- Subject used any prescribed or nonprescribed drugs (including vitamins, oral contraceptives or hormone replacement therapy, natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to study drug administration, except for occasional use of acetaminophen (up to 2 g per day).
- Subject has any clinically significant abnormality following the investigator's review of the physical examination, ECG and protocol defined clinical laboratory tests at screening or day -1.
- Subject uses any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the clinical unit.
- Subject has a positive serology test for hepatitis B surface antigen, hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies, hepatitis B core antibody or human immunodeficiency virus type 1 or 2 at screening.
- Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy, as judged by the investigator.
- Subject has any of the liver chemistry tests (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and total bilirubin) above the upper limit of normal at day -1. If the test is outside the reference range, the test may be repeated once.
- In addition, subjects with mild or moderate hepatic impairment must also NOT meet the following exclusion criteria:
- Subject has any clinically significant abnormality, not related to their current disease state, following the investigator's review of the physical examination, ECG and protocol defined clinical laboratory tests at screening or day -1.
- Subject has a fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment within the screening period (e.g., worsening ascites, infection of ascites, fever, active gastrointestinal bleeding).
- Subject has had a change in dose regimen of medically required medication within the last 2 weeks before prestudy examination (allowed co medication in patients), and/or the use of unallowed co medication in the 3 weeks prior to admission to the clinical unit (not allowed: any known hepatic enzyme altering agents or compounds known to restrict metabolism).
- Subject has presence of a hepatocellular carcinoma or an acute liver disease caused by an infection or drug toxicity.
- Subject has severe portal hypertension or surgical porto-systemic shunts, including Transjugular intrahepatic portosystemic shunt (TIPSS).
- Subject has biliary liver cirrhosis, biliary obstruction or other cause of hepatic impairment not related to parenchymal disorder and/or disease of the liver.
- Subject has signs of significant hepatic encephalopathy (hepatic encephalopathy grade >2).
- Subject has severe ascites and/or pleural effusion.
- Subject had esophageal/gastric variceal bleeding in the past 6 months prior to screening.
- Subject has a thrombocyte level below 40 × 109 /L and/or hemoglobin below 90 g/L.
- Subject had a previous liver transplantation.
- Subject has severe or moderate renal dysfunction (estimated glomerular filtration rate [eGFR] below 60 mL/min/1.73m2) estimated via the following Modification of Diet in Renal Disease (MDRD) equation: eGFR (mL/min/1.73 m2) = 175 × (SCr [mg/dL]) -1.154 × (Age) -0.203 × (0.742 if female) × (1.212 if black)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215
The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in subjects with mild and moderate hepatic impairment to matched healthy subjects with normal hepatic function.
This study will also assess the safety and tolerability of single-dose ASP2215 in subjects with mild and moderate hepatic impairment and matched control subjects.
Read the detailed description
Subjects will be admitted to the site one day before each study drug administration (i.e. Day -1) and confined at the site till the collection of post-dose PK samples (Day 21). For subjects with hepatic impairment, subject will discharge on Day 21, and will visit the clinical unit on Day 24 (±1 day) and Day 28 (±1 day) for collection of post-dose PK samples. End of study Visit For Healthy subjects will take place 1 to 5 days following collection of last PK sample.
- Conditions
- Hepatic Impairment, Healthy
- Being tested
- ASP2215
- Keywords
- Hepatic Impairment, Mild Hepatic Impairment, Healthy, ASP2215, Moderate Hepatic Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP2215Drug
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP2215: Subjects with mild hepatic impairment | Experimental | Subjects with Child Pugh classification score of 5-6 (mild) Receives: Drug: ASP2215 |
| ASP2215: Subjects with moderate hepatic impairment | Experimental | Subjects with Child Pugh classification score of 7-9 (moderate) Receives: Drug: ASP2215 |
| ASP2215: Subjects with normal hepatic function | Experimental | Healthy subjects that match with respect to age, sex and body mass index (BMI) Receives: Drug: ASP2215 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of ASP2215 in plasma: AUCinf
Area under the curve from time zero to infinity (AUCinf)
Measured: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: AUClast, 480
Area under the concentration-time curve from the time of dosing to the last measurable concentration within 480 hours postdose (AUClast,480)
Measured: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: Cmax
Maximum concentration (Cmax)
Measured: Up to Day 28
Secondary outcomes (13)
Pharmacokinetics of ASP2215 in plasma: t1/2
Apparent Terminal Elimination Half-life (t1/2)
Measured: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: tmax
The time after dosing when Cmax occurs (tmax)
Measured: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: CL/F
Apparent total systemic clearance after extravascular dosing (CL/F)
Measured: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: Vz/F
Apparent volume of distribution during the terminal elimination phase after single extravascular dosing (Vz/F)
Measured: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: fu
Fraction of parent or metabolite available systemically unbound (=free fraction) (fu)
Measured: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: AUClast
Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
Measured: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: AUClast,u
Area under the concentration-time curve from the time of dosing to the last measurable concentration for unbound concentration (AUClast,u)
Measured: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: AUCinf,u
Area under the concentration-time curve from the time of dosing extrapolated to time infinity for unbound concentration (AUCinf,u)
Measured: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: AUClast,480,u
Area under the concentration-time curve from the time of dosing to the last measurable concentration within 480 postdose for unbound concentration (AUClast,480,u)
Measured: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: Cmax,u
Maximum concentration for unbound concentration (Cmax,u)
Measured: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: CLu/F
Apparent total systemic clearance of unbound ASP2215 after extravascular dosing (CLu//F)
Measured: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: Vz,u/F
Apparent volume of distribution during the terminal elimination phase of unbound ASP2215 after extravascular dosing (Vz,u/F)
Measured: Up to Day 28
Safety profile assessed by Adverse Events (AEs), Clinical laboratory evaluations, 12-Lead electrocardiogram (ECG) and Vital signs
Clinical laboratory evaluations include hematology, biochemistry, and urinalysis. Vital signs include oral temperature, respiration rate, pulse, and supine blood pressure.
Measured: Up to Day 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study start23 Oct 2015
- Primary completion5 Mar 2016
- Study completion5 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571816
- Sponsor's protocol ID
- 2215-CL-0106
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2015
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
James AJ, Smith CC, Litzow M, Perl AE, Altman JK, Shepard D, Kadokura T, Souda K, Patton M, Lu Z, Liu C, Moy S, Levis MJ, Bahceci E. Pharmacokinetic Profile of Gilteritinib: A Novel FLT-3 Tyrosine Kinase Inhibitor. Clin Pharmacokinet. 2020 Oct;59(10):1273-1290. doi: 10.1007/s40262-020-00888-w.
PubMed 32304015
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215
- ClinicalTrials.gov ID
- NCT02571816
- Acronym / sponsor ID
- 2215-CL-0106
- Conditions
- Hepatic Impairment, Healthy
- Keywords
- Hepatic Impairment, Mild Hepatic Impairment, Healthy, ASP2215, Moderate Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2015 (actual)
- Primary completion
- 5 Mar 2016 (actual)
- Study completion
- 5 Mar 2016 (actual)
- First posted
- 8 Oct 2015 (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.
The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in subjects with mild and moderate hepatic impairment to matched healthy subjects with normal hepatic function.
This study will also assess the safety and tolerability of single-dose ASP2215 in subjects with mild and moderate hepatic impairment and matched control subjects.
Detailed description
Subjects will be admitted to the site one day before each study drug administration (i.e. Day -1) and confined at the site till the collection of post-dose PK samples (Day 21). For subjects with hepatic impairment, subject will discharge on Day 21, and will visit the clinical unit on Day 24 (±1 day) and Day 28 (±1 day) for collection of post-dose PK samples. End of study Visit For Healthy subjects will take place 1 to 5 days following collection of last PK sample.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASP2215: Subjects with mild hepatic impairment | Experimental | Drug: ASP2215Subjects with Child Pugh classification score of 5-6 (mild) |
| ASP2215: Subjects with moderate hepatic impairment | Experimental | Drug: ASP2215Subjects with Child Pugh classification score of 7-9 (moderate) |
| ASP2215: Subjects with normal hepatic function | Experimental | Drug: ASP2215Healthy subjects that match with respect to age, sex and body mass index (BMI) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject has a Body Mass Index (BMI) range of 18.5 - 34.0 kg/m2, inclusive and weighs at least 50 kg at screening.
- Female subject must be nonchildbearing potential;
- Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 45 days after the final study drug administration.
- Female subject must not donate ova starting at screening and throughout the study period and for 45 days after the final study drug administration.
- Male subject and their female spouse/partners who are of childbearing potential must be using 2 forms of highly effective birth control (1 of which must be a barrier method) starting at screening and continue throughout the study period and for 105 days after the final study drug administration.
Key exclusion criteria (42 listed)
- A prospective subject will be excluded from participation in this clinical study if any of the following apply:
- Female subject who has been pregnant within 6 months prior to screening assessment or breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to ASP2215, or any components of the formulation used.
- Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies prior to study drug administration).
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to day -1.
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 |
|---|---|---|
| ASP2215oral | Drug | ASP2215: Subjects with mild hepatic impairment, ASP2215: Subjects with moderate hepatic impairment, ASP2215: Subjects with normal hepatic function |
Primary outcome
Pharmacokinetics of ASP2215 in plasma: AUCinf
Time frame: Up to Day 28
Area under the curve from time zero to infinity (AUCinf)
Pharmacokinetics of ASP2215 in plasma: AUClast, 480
Time frame: Up to Day 28
Area under the concentration-time curve from the time of dosing to the last measurable concentration within 480 hours postdose (AUClast,480)
Pharmacokinetics of ASP2215 in plasma: Cmax
Time frame: Up to Day 28
Maximum concentration (Cmax)
13 secondary outcomes
Pharmacokinetics of ASP2215 in plasma: t1/2
Time frame: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: tmax
Time frame: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: CL/F
Time frame: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: Vz/F
Time frame: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: fu
Time frame: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: AUClast
Time frame: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: AUClast,u
Time frame: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: AUCinf,u
Time frame: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: AUClast,480,u
Time frame: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: Cmax,u
Time frame: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: CLu/F
Time frame: Up to Day 28
Pharmacokinetics of ASP2215 in plasma: Vz,u/F
Time frame: Up to Day 28
Safety profile assessed by Adverse Events (AEs), Clinical laboratory evaluations, 12-Lead electrocardiogram (ECG) and Vital signs
Time frame: Up to Day 34
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 5 Nov 2024.
- Derived from this study: PubMed 32304015James AJ, Smith CC, Litzow M, Perl AE, Altman JK, Shepard D, Kadokura T, Souda K, Patton M, Lu Z, Liu C, Moy S, Levis MJ, Bahceci E. Pharmacokinetic Profile of Gilteritinib: A Novel FLT-3 Tyrosine Kinase Inhibitor. Clin Pharmacokinet. 2020 Oct;59(10):1273-1290. doi: 10.1007/s40262-020-00888-w.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Medical Monitor study director
Astellas Pharma Global Development, Inc.
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 ASP2215 in people with Hepatic Impairment and Healthy, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
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 13 inclusion and 42 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 5 Nov 2024. 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 States. 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?
Pharmacokinetics of ASP2215 in plasma: AUCinf (time frame: Up to Day 28). The study lists 3 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 NCT02571816, 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 5 Nov 2024.