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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 is a Phase 2 study that was terminated before completion, run by Genfit. The registered enrollment target is 10 participants.

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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).

Interventions

  • DRUG Elafibranor 80mg
  • DRUG Elafibranor 120mg

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2019-06-25
Est. Completion 2020-06-16
Phase Phase 2

Sponsor

Genfit

11 total trials

What the Registry Record Tells You About NCT03883607

The ClinicalTrials.gov registry entry for NCT03883607 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genfit, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Elafibranor 80mg is the first listed.

NCT03883607 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.