16 completed, 5 terminated, 1 not yet recruiting, 1 recruiting. 12 Phase 2, 11 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 6, Terminated 4, Not yet recruiting 1, Recruiting 1 |
| Phase 1 | 11 | Completed 10, Recruiting 1 |
| Phase 3 | 1 | Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Phase 2 Study of 500 mg BID NTZ on Top of Standard of Care in Patients With Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acute-on-Chronic Liver Failure NTZ 500mg BID on top of SOC - Acute Decompensation of Liver Cirrhosis, Established Acute-on-Chronic Liver Failure | Phase 2 | Not yet recruiting | Genfit | 16 | 2026-10-01 | 2026-07-09 |
| Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy Volunteers Single Dose G1090N, Multiple dosing of G1090N - Acute-on-Chronic Liver Failure | Phase 1 | Completed | Genfit | 52 | 2025-08-26 | 2026-01-16 |
| A Study to See if an Investigational Medicine Called VS-01 Can Help and How Safe it is in the Treatment of Patients With Overt Hepatic Encephalopathy VS-01 on top of SOC (Active Treatment Group), SOC - Hepatic Encephalopathy, Acute on Chronic Liver Failure (ACLF) | Phase 2 | Terminated | Genfit | 3 | 2025-08-25 | 2026-01-12 |
| Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma GNS561 + Trametinib - Cholangiocarcinoma | Phase 1 / Phase 2 | Recruiting | Genfit | 98 | 2023-08-21 | 2026-07-13 |
| Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)® VS-01 on top of SOC, SOC (Control Group) - Acute-On-Chronic Liver Failure, Ascites | Phase 2 | Terminated | Genfit | 15 | 2023-07-02 | 2026-07-23 |
| Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects Nitazoxanide - Renal Impairment, Renal Disease | Phase 1 | Completed | Genfit | 77 | 2022-04-25 | 2022-10-28 |
| Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients Nitazoxanide - Moderate Hepatic Impairment, Severe Hepatic Impairment | Phase 1 | Completed | Genfit | 25 | 2021-11-05 | 2022-10-14 |
| Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers elafibranor - Geriatrics, Healthy | Phase 1 | Completed | Genfit | 21 | 2019-11-22 | 2020-08-13 |
| Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and Indomethacin elafibranor, CHRONO-INDOCID - Drug-drug Interaction | Phase 1 | Completed | Genfit | 26 | 2019-09-23 | 2020-08-13 |
| Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL) elafibranor 120mg, Placebo - Non-Alcoholic Fatty Liver | Phase 2 | Terminated | Genfit | 17 | 2019-08-16 | 2020-08-31 |
| Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH) Elafibranor 80mg, Elafibranor 120mg - Non Alcoholic Steatohepatitis | Phase 2 | Terminated | Genfit | 10 | 2019-06-25 | 2021-10-28 |
| Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients Elafibranor - Renal Impairment, Renal Insufficiency | Phase 1 | Completed | Genfit | 23 | 2019-02-28 | 2020-08-13 |
| Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients Elafibranor - Hepatic Impairment, Liver Disease | Phase 1 | Completed | Genfit | 30 | 2018-12-12 | 2019-08-22 |
| Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid Elafibranor 80 mg, Elafibranor 120 mg, Placebo - Primary Biliary Cholangitis (PBC) | Phase 2 | Completed | Genfit | 45 | 2017-04-05 | 2019-09-24 |
| Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) Elafibranor, Placebo - Nonalcoholic Steatohepatitis (NASH) With Fibrosis | Phase 3 | Terminated | Genfit | 2157 | 2016-03-01 | 2022-03-23 |
| Mass Balance Study of 14C-labelled GFT505 in Healthy Volunteers 14C-labelled GFT505 120 mg - Healthy | Phase 1 | Completed | Genfit | 6 | 2014-04-01 | 2015-05-29 |
| Phase I Study to Evaluate the Effect of GFT505 on QT/QTc Interval in Healthy Volunteers Placebo, GFT505, Moxifloxacin 400 mg - Healthy Volunteers | Phase 1 | Completed | Genfit | 200 | 2014-02-01 | 2015-03-10 |
| Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) GFT505 80mg, GFT505 120mg, Placebo - Non-Alcoholic Steatohepatitis (NASH) | Phase 2 | Completed | Genfit | 275 | 2012-09-01 | 2022-11-03 |
| Comparative Bioavailability - Gender Effect - Single and Multiple Ascending Dose Safety and Pharmacokinetic Study of GFT505 GFT505 120mg - old formulation, GFT505 120mg - new formulation, GFT505 180mg - new formulation - Type 2 Diabetes, Diabetes Mellitus, Type 2 | Phase 1 | Completed | Genfit | 96 | 2011-11-01 | 2012-11-27 |
| Pilot Study With GFT505 (80mg) in Patients With Insulin Resistance and Abdominal Obesity GFT505 80mg, Placebo - Insulin Resistance, Abdominal Obesity | Phase 2 | Completed | Genfit | 22 | 2011-01-01 | 2012-09-24 |
Showing 20 of 23. Sign in to see all of them.
Acute-On-Chronic Liver Failure (4) · Fibrosis (4) · Liver Diseases (4) · Non-alcoholic Fatty Liver Disease (4) · Kidney Diseases (3) · Obesity, Abdominal (3) · Renal Insufficiency (3) · Cardiovascular Diseases (2) · Diabetes Mellitus, Type 2 (2) · Glucose Intolerance (2) · Metabolic Diseases (2) · Ascites (1) · Bile Duct Neoplasms (1) · Cholangiocarcinoma (1) · Dyslipidemias (1)
2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid (15) · nitazoxanide (3) · Control Groups (1) · Indomethacin (1) · Moxifloxacin (1) · trametinib (1)
France (13) · United States (11) · Romania (5) · Belgium (4) · Germany (4) · Spain (4) · Italy (3) · Netherlands (3) · United Kingdom (3) · Puerto Rico (2) · Argentina (1) · Australia (1) · Bosnia and Herzegovina (1) · Canada (1) · Chile (1)
Pascal Birman, MD (4) · Carol Addy, MD (2) · Carol Addy, MD MMSc (2) · Philippe Betting, MD (1)
PMID 23703580, PMID 21816979, PMID 23715754, PMID 26874076, PMID 33484775, PMID 37084342
2019 (4), 2008 (1), 2009 (1), 2014 (1), 2015 (1), 2016 (1), 2018 (1), 2025 (1)