NCT03883607

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

An Open Label, Randomized, Multicenter Study to Assess the Pharmacokinetic and Pharmacodynamic Profile and the Safety and Tolerability of Two Dose Levels of Elafibranor (80 mg and 120 mg) in Children and Adolescents, 8 to 17 Years of Age, With Nonalcoholic Steatohepatitis (NASH)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Genfit · Industry
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-06-25
• Primary completion: 2020-06-16
• Completion: 2020-06-16
• First posted: 2019-03-21
• Last updated: 2021-10-28
• Results posted: 2021-10-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study