Clinical trials: Cirrhosis
Edema Due to Heart Failure or Cirrhosis
A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients
This is a 2-part, 2 periods per part, open-label study with spironolactone oral suspension in pediatric patients with edema due to HF or hepatic cirrhosis.
- Trial name
- NCT06021860
- Testing
- Spironolactone Oral Suspension
- Volunteers
- 96 people
- Sponsor
- CMP Development, LLC
Safety and Tolerability
A First in Human Study to Evaluate the Safety, Tolerability and PK of GB1211 in Healthy Subjects
This was a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered GB1211 will be evaluated in healthy adult subjects and adult…
- Trial name
- NCT03809052
- Testing
- GB1211
- Where
- United Kingdom
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Galecto Biotech AB
Pruritus, Primary Biliary Cholangitis
TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis
A phase 2a, multicenter, randomized, double-blind, placebo-controlled study of TH104 in primary biliary cholangitis (PBC) participants with moderate to severe pruritus.
- Trial name
- NCT06733519
- Testing
- Nalmefene
- Volunteers
- 40 people
- Sponsor
- Tharimmune Inc
Primary Biliary Cholangitis
Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis
Saroglitazar Magnesium 1 mg and 2 mg tablets for treatment of subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- EPICS-III (NCT05133336)
- Testing
- Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg
- Where
- 57 sites in United States, Argentina and 2 more
- Volunteers
- 196 people
- Sponsor
- Zydus Therapeutics Inc.
Chronic Hepatitis C Virus (HCV)
ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis
This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT-450/r/ ABT-267 and ABT-333 coadministered with RBV for 12 weeks in HCV genotype 1b, treatment naïve and Interferon (IFN) (alpha, beta or…
- Trial name
- NCT02517528
- Testing
- ABT-450/r/ABT-267, ABT-333, ribavirin
- Volunteers
- 104 people
- Sponsor
- AbbVie
Chronic Hepatitis C, Hepatitis C Virus
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection
The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) at different doses in…
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, HCV
- Trial name
- NCT02243280
- Testing
- ABT-493, ABT-530
- Volunteers
- 174 people
- Sponsor
- AbbVie
Hepatic Impairment, Cirrhosis
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease
- Conditions
- Hepatic Impairment, Cirrhosis, Cholestatic Liver Disease
- Trial name
- NCT05045482
- Testing
- Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zydus Therapeutics Inc.
Hepatic Impairment, Cirrhosis
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
In this study, a single dose of VIR-2218 up to 200 mg SC or VIR-3434 at 300 mg SC monotherapy or a combination of VIR-2218 and VIR-3434 will be administered to assess the pharmacokinetic (PK) exposure, safety, and tolerability of…
- Trial name
- NCT05484206
- Testing
- VIR-2218, VIR-3434
- Where
- 4 sites in United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.
Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Evaluating the Pharmacokinetics and Safety of Miricorilant
A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Non-alcoholic Fatty Liver Disease (NAFLD)
- Trial name
- NCT07553663
- Testing
- Miricorilant
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Corcept Therapeutics
Moderate Liver Impairment, Severe Liver Impairment
A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment
The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment.
- Trial name
- NCT04634149
- Testing
- BMS-986036
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Nonalcoholic Steatohepatitis
Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
The goal of this clinical study is to understand whether the study drugs, semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR), cause fibrosis improvement and Nonalcoholic Steatohepatitis…
- Trial name
- WAYFIND (NCT04971785)
- Testing
- Semaglutide (SEMA), Cilofexor (CILO)/Firsocostat (FIR), PTM SEMA
- Where
- 242 sites in United States, Australia and 5 more
- Volunteers
- 457 people
- Sponsor
- Gilead Sciences
Nonalcoholic Steatohepatitis
Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
The primary objectives of this study are: To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or…
- Trial name
- ATLAS (NCT03449446)
- Testing
- SEL, FIR, CILO
- Where
- 101 sites in United States, Australia and 4 more
- Volunteers
- 395 people
- Sponsor
- Gilead Sciences
Cirrhosis
A Trial of OPC-41061 in Patients With Hepatic Edema - Investigation of the Safety of Treatment at 7.5 mg Beyond 7 Days and of the Effect of Dose Escalation to 15 mg
OPC-41061 will be orally administered at 7.5 mg/day for 7 days to cirrhosis patients with ascites despite having received conventional diuretic therapy.
- Trial name
- NCT01048788
- Testing
- OPC-41061
- Where
- 6 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Acute on Chronic Hepatic Failure
Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units
Patients with compensated chronic liver disease who have an episode of acute deterioration of liver function (acute-on-chronic liver failure) are known to have up to 90% mortality rate.
- Trial name
- HEPATICUS-1 (NCT01079091)
- Testing
- ADVOS (Hepa Wash), Standard Medical Therapy
- Where
- Germany
- Volunteers
- 14 people
- Sponsor
- Hepa Wash GmbH
Hepatic Ascites
Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects
This trial adopts a randomized, double-blind, positive drug-controlled, dose-escalated phase Ib clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary effectiveness of recombinant…
- Trial name
- NCT05249374
- Testing
- Recombinant Human Serum Albumin, Human serum albumin
- Where
- 8 sites in China
- Volunteers
- 36 people
- Sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.
Primary Biliary Cholangitis
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis
- Trial name
- NCT03394924
- Testing
- EDP-305 1 mg, EDP-305 2.5 mg
- Where
- 86 sites in United States, Australia and 8 more
- Volunteers
- 68 people
- Sponsor
- Enanta Pharmaceuticals, Inc
Liver Cirrhosis, Hepatic Cirrhosis
A Study of IDN-6556 in Cirrhotic Subjects With Portal Hypertension
This is an open-label pilot study to evaluate the safety, tolerability, and efficacy of IDN-6556 in treating portal hypertension in subjects with liver cirrhosis.
- Conditions
- Liver Cirrhosis, Hepatic Cirrhosis, Portal Hypertension
- Trial name
- PH (NCT02230683)
- Testing
- IDN-6556
- Where
- 16 sites in United States
- Volunteers
- 23 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Hepatitis C, Chronic
A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive
The main purpose of this study is to evaluate the safety and tolerability of a combination treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese participants with genotype 1 or 2 chronic hepatitis C…
- Trial name
- NCT02993250
- Testing
- AL-335, Odalasvir (ODV), Simeprevir (SMV)
- Where
- 14 sites in Japan
- Volunteers
- 33 people
- Sponsor
- Janssen Pharmaceutical K.K.
Primary Biliary Cholangitis
Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
This study is a Phase 2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-104.
- Trial name
- NCT05104853
- Testing
- CNP-104
- Where
- 19 sites in United States
- Volunteers
- 42 people
- Sponsor
- COUR Pharmaceutical Development Company, Inc.
Hepatitis C Virus
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1)
The purpose of this study in HCV genotype 4-infected participants with compensated cirrhosis is to assess the safety and to compare the percentage of participants achieving a 12-week sustained virologic response (SVR12), [HCV…
- Trial name
- AGATE-1 (NCT02265237)
- Testing
- ombitasvir/paritaprevir/ritonavir, ribavirin
- Volunteers
- 184 people
- Sponsor
- AbbVie