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NCT03008070 · ClinicalTrials.gov registry record · Phase 2
Phase 2b Study in NASH to Assess IVA337
A Phase 2 study of Non-alcoholic Steatohepatitis (NASH), sponsored by Inventiva Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 247
- Enrollment target
- 20
- Study locations
NCT03008070: Completed Phase 2 study of Non-alcoholic Steatohepatitis (NASH), sponsored by Inventiva Pharma.
NCT03008070 is a Phase 2 study of Non-alcoholic Steatohepatitis (NASH) that has completed, run by Inventiva Pharma. The registered enrollment target is 247 participants, above the 181-participant average among 16 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (36% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03008070, a Phase 2 study of Non-alcoholic Steatohepatitis (NASH), has completed, sponsored by Inventiva Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 247 participants
- Enrollment target
- 20
- Study locations
Study Summary
Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes mellitus, or insulin resistance and is very common. However, Treatment of NASH is a significant unmet clinical need. IVA337 (lanifibranor) is a next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist addressing the pathophysiology of NASH : metabolic, inflammatory and fibrotic. The purpose of this research is to evaluate the efficacy and the safety of two doses of IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver steatosis and moderate to severe necroinflammation without cirrhosis.
Primary Outcome
SAF-A is the activity part of the Steatosis Activity Fibrosis \[SAF\] histological score, calculated as the sum of lobular inflamation score and balloning score. No worsening of fibrosis means that the CRN fibrosis score (CRN-F) remains stable or decreases.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG IVA337
Study Locations (20)
Other
- Flinders Medical Centre Department of Hepatology - Bedford Park
- Monash Medical Centre - Clayton
- Lyell McEwin Hospital & The University of Adelaide - Elizabeth Vale
- Royal Brisbane and Women's Hospital - Herston
- Fiona Stanley Hospital - Murdoch
- Medical University Vienna - Vienna
California
- ACTRI - La Jolla
- National Research Institute - Los Angeles
Florida
- Palmetto Research, LLC - Hialeah
- Florida Digestive Health Specialists, LLP - Lakewood Rch
North Carolina
- Duke University Medical Center - Durham
- Carolina's Center for Liver Disease/CHG - Huntersville
Texas
- The Texas Liver Institute - San Antonio
- Digestive Health Research, LLC - San Antonio
Virginia
- University of Virginia Health System - Charlottesville
- Virginia Commonwealth University - Richmond
Alabama
- North Alabama GI Research Center - Madison
Massachusetts
- Northeast GI Research Division - Concord
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2017-02-07 |
| Est. Completion | 2020-03-16 |
| Phase | Phase 2 |
What the finished NCT03008070 record still lists
NCT03008070 is an interventional study that assigns participants to a tested intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap, above the 181-participant average among 16 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (36% higher).
The record links to 1 condition, with Non-alcoholic Steatohepatitis (NASH) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03008070 names 20 study sites across 10 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03008070 about?
NCT03008070 is a clinical study titled "Phase 2b Study in NASH to Assess IVA337". Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes mellitus, or insulin resistance and is very common. However, Treatment of NASH is a significant unmet clinical need. IVA33...
What is the current status of trial NCT03008070?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 247 participants. The study started on 2017-02-07. Estimated completion is 2020-03-16.
What conditions does trial NCT03008070 study?
This clinical trial studies the following conditions: Non-alcoholic Steatohepatitis (NASH).
What interventions are being tested in trial NCT03008070?
The interventions under investigation include: Placebo (DRUG), IVA337 (DRUG).
Who is sponsoring clinical trial NCT03008070?
This trial is sponsored by Inventiva Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03008070 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Massachusetts, North Carolina. 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 NCT03008070's enrollment target sits among peer trials
247 4th of 16 higher than 13 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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