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NCT03883607 · ClinicalTrials.gov registry record · Phase 2
Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)
A Phase 2 study, sponsored by Genfit.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT03883607: Clinical Trial Phase 2 study, sponsored by Genfit.
NCT03883607 is a Phase 2 study that was terminated before completion, run by Genfit. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03883607, a Phase 2 study, was terminated before completion, sponsored by Genfit.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
The study was being conducted in order to assess the pharmacokinetics and the safety of elafibranor following once daily administration of two dose levels of elafibranor (80 milligrams \[mg\] and 120mg) during 3 months in children and adolescent population (8 to 17 years of age) with non alcoholic steatohepatitis (NASH).
Primary Outcome
Cmax was defined as maximum observed plasma concentration.
Interventions
- DRUG Elafibranor 80mg
- DRUG Elafibranor 120mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-06-25 |
| Est. Completion | 2020-06-16 |
| Phase | Phase 2 |
Why NCT03883607 stopped before completion
NCT03883607 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Elafibranor 80mg is the first listed.
NCT03883607 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03883607 about?
NCT03883607 is a clinical study titled "Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)". The study was being conducted in order to assess the pharmacokinetics and the safety of elafibranor following once daily administration of two dose levels of elafibranor (80 milligrams \[mg\] and 120mg) during 3 months in children and adolescent population (8 to 17 years of age) with non alcoholic s...
What is the current status of trial NCT03883607?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2019-06-25. Estimated completion is 2020-06-16.
What interventions are being tested in trial NCT03883607?
The interventions under investigation include: Elafibranor 80mg (DRUG), Elafibranor 120mg (DRUG).
Who is sponsoring clinical trial NCT03883607?
This trial is sponsored by Genfit, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03883607's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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