CLINICAL TRIALS PROFILE FOR ELAFIBRANOR
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All Clinical Trials for elafibranor
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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NCT02704403 ↗ | Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) | Terminated | Genfit | Phase 3 | 2016-03-01 | The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. |
NCT03124108 ↗ | Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid | Completed | Genfit | Phase 2 | 2017-04-05 | The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA). |
NCT03765671 ↗ | Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients | Completed | Syneos Health | Phase 1 | 2018-12-12 | This study is being conducted in order to assess the need for dose adjustment for elafibranor in patients with hepatic impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in hepatic impaired patients (mild, moderate and severe according to Child-Pugh categories) versus healthy participants after a single oral administration of elafibranor 120 mg. |
NCT03765671 ↗ | Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients | Completed | University of Miami | Phase 1 | 2018-12-12 | This study is being conducted in order to assess the need for dose adjustment for elafibranor in patients with hepatic impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in hepatic impaired patients (mild, moderate and severe according to Child-Pugh categories) versus healthy participants after a single oral administration of elafibranor 120 mg. |
NCT03765671 ↗ | Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients | Completed | Genfit | Phase 1 | 2018-12-12 | This study is being conducted in order to assess the need for dose adjustment for elafibranor in patients with hepatic impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in hepatic impaired patients (mild, moderate and severe according to Child-Pugh categories) versus healthy participants after a single oral administration of elafibranor 120 mg. |
NCT03844555 ↗ | Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients | Completed | Genfit | Phase 1 | 2019-02-28 | This study is being conducted in order to assess the need for dose adjustment for elafibranor in participants with renal impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in severe renal impaired participants (eGFR<15mL/mn/1.73m^2) versus healthy participants after a single oral administration of elafibranor 120 mg |
NCT03883607 ↗ | Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH) | Terminated | Genfit | Phase 2 | 2019-06-25 | 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). |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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