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Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)

NCT03883607 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-10-28

Study results available
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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).

Conditions

  • Non Alcoholic Steatohepatitis

Interventions

DRUG

Elafibranor 80mg

Once daily oral intake of elafibranor 80 mg during 3 months

DRUG

Elafibranor 120mg

Once daily oral intake of elafibranor 120 mg during 3 months

Sponsors & Collaborators

  • Genfit

    lead INDUSTRY

Principal Investigators

  • Carol Addy, MD MMSc · Genfit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2020-06-16
Completion
2020-06-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03883607 on ClinicalTrials.gov