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NCT02466516 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
A Phase 2 study of Non-alcoholic Steatohepatitis (NASH), sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 20
- Study locations
NCT02466516: Completed Phase 2 study of Non-alcoholic Steatohepatitis (NASH), sponsored by Gilead Sciences.
NCT02466516 is a Phase 2 study of Non-alcoholic Steatohepatitis (NASH) that has completed, run by Gilead Sciences. The registered enrollment target is 72 participants, below the 192-participant average among 16 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02466516, a Phase 2 study of Non-alcoholic Steatohepatitis (NASH), has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of GS-4997 (selonsertib \[SEL\]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic steatohepatitis (NASH) and fibrosis stages F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.
Primary Outcome
Treatment-emergent events began on or after the first dosing date up to 30 days after the last dosing date or led to premature discontinuation of study drug. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Conditions Studied
Interventions
- DRUG SEL
- BIOLOGICAL SIM
Study Locations (20)
Texas
- Texas Clinical Research Institute - Arlington
- Methodist Dallas Medical Center - Dallas
- CHI St. Luke's Health Baylor College of Medicine - Houston
- Brooke Army Medical Center Ft. Sam - Houston
- Digestive Research Center - Live Oak
- American Research Corporation at Texas Liver Institute - San Antonio
California
- Stanford University Medical Center - Palo Alto
- University of California San Diego - San Diego
- University of California San Francisco - San Francisco
Maryland
- Mercy Medical Center - Baltimore
- Walter Reed National Military Medical Center - Bethesda
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
- University of Pittsburg Medical Center - Pittsburgh
Colorado
- University of Colorado Denver - Aurora
Illinois
- Northwestern University - Chicago
Indiana
- Indiana University School of Medicine - Indianapolis
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2015-06-08 |
| Est. Completion | 2016-10-11 |
| Phase | Phase 2 |
What the finished NCT02466516 record still lists
NCT02466516 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 192-participant average among 16 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Non-alcoholic Steatohepatitis (NASH) appearing as the primary indexed condition, and to 2 interventions - of which SEL is the first listed.
NCT02466516 names 20 study sites across 11 states, led by Texas, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT02466516 about?
NCT02466516 is a clinical study titled "Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3". The primary objective of this study is to evaluate the safety and tolerability of GS-4997 (selonsertib \[SEL\]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic steatohepatitis (NASH) and fibrosis stages F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 s...
What is the current status of trial NCT02466516?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2015-06-08. Estimated completion is 2016-10-11.
What conditions does trial NCT02466516 study?
This clinical trial studies the following conditions: Non-alcoholic Steatohepatitis (NASH).
What interventions are being tested in trial NCT02466516?
The interventions under investigation include: SEL (DRUG), SIM (BIOLOGICAL).
Who is sponsoring clinical trial NCT02466516?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02466516 being conducted?
This trial has 20 study locations across California, Colorado, Illinois, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02466516's enrollment target sits among peer trials
72 13th of 16 higher than 4 of 16 other Non-alcoholic Steatohepatitis (NASH) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-alcoholic Steatohepatitis (NASH) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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