Clinical trials: Compensated Cirrhosis
Compensated Cirrhosis, Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
- Trial name
- REVERSE (NCT03439254)
- Testing
- Obeticholic acid (10 mg), Obeticholic acid (10 mg to 25 mg)
- Where
- 192 sites in United States, Australia and 10 more
- Volunteers
- 919 people
- Sponsor
- Intercept Pharmaceuticals
Chronic Hepatitis C Virus, Hepatitis C Virus
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection
The purpose of this phase 3, multicenter study is to evaluate the efficacy and safety of ABT-493/ABT-530 in Japanese adults with chronic Hepatitis C Virus (HCV)-infected, HCV direct-acting antiviral agent (DAA) treatment-naïve…
- Trial name
- CERTAIN-1 (NCT02707952)
- Testing
- ABT-493/ABT-530, OBV/PTV/r
- Volunteers
- 295 people
- Sponsor
- AbbVie
Hepatitis B, Chronic
Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis
Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of liver disease that predisposes patients to the development of hepatocellular carcinoma (HCC).
- Trial name
- NCT02224456
- Testing
- Tenofovir disoproxil fumarate
- Where
- 19 sites in China
- Volunteers
- 197 people
- Sponsor
- GlaxoSmithKline
Non-alcoholic Steatohepatitis
A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage
Semaglutide is a medicine studied in patients with non-alcoholic steatohepatitis (NASH), as it may improve liver damage. Participants will either get semaglutide or placebo (a dummy medicine) - which treatment participants get is…
- Trial name
- NCT03987451
- Testing
- Semaglutide
- Where
- 38 sites in United States, France and 3 more
- Volunteers
- 71 people
- Sponsor
- Novo Nordisk A/S
Compensated Liver Cirrhosis, Metabolic Dysfunction Associated Steatohepatitis (MASH)
A Study to Test How Well BI 770371 is Tolerated by People With Cirrhosis Caused by a Liver Disease Called MASH
This study is open to people with cirrhosis caused by a liver disease called MASH (metabolic dysfunction-associated steatohepatitis). The purpose of this study is to find out how well a medicine called BI 770371 is tolerated.
- Trial name
- NCT06675929
- Testing
- BI 770371
- Where
- 13 sites in United States
- Volunteers
- 28 people
- Sponsor
- Boehringer Ingelheim
Metabolic Dysfunction Associated Steatohepatitis
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
This study is open to adults who are at least 18 years old and have: A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or A confirmed liver disease called metabolic-associated steatohepatitis (MASH) BMI of 27…
- Trial name
- NCT06632457
- Testing
- Survodutide
- Where
- 447 sites in United States, Argentina and 35 more
- Volunteers
- 1,590 people
- Sponsor
- Boehringer Ingelheim
Early Cirrhosis
Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis
This randomized, double-blind, controlled, clinical food study aims to explore KB174, a novel mixture of oligosaccharides, and maltodextrin, an easily digestible polysaccharide, on gut microbiome structure and function in…
- Trial name
- NCT03855956
- Testing
- KB174, Maltodextrin
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Kaleido Biosciences
Hypertension, Portal
A Study to Test Whether Two Different Doses of Avenciguat Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)
This study is open to adults with liver cirrhosis and high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether a medicine called Avenciguat helps people with this…
- Trial name
- NCT05161481
- Testing
- Avenciguat (BI 685509)
- Where
- 45 sites in United States, Argentina and 20 more
- Volunteers
- 80 people
- Sponsor
- Boehringer Ingelheim
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
Hepatitis C, Chronic, Liver Cirrhosis
Inhibition of Disease Progression in Hepatitis C-infected Patients With Compensated Liver Cirrhosis (P03811) (COMPLETED)
The objective of the study is to evaluate the superiority of treatment with PegIntron and Rebetol over no antiviral therapy (control group) in subjects with chronic hepatitis C and type C compensated cirrhosis.
- Trial name
- NCT00811967
- Testing
- PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Volunteers
- 50 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C
Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis
The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced…
- Trial name
- NCT02319031
- Testing
- Daclatasvir, Sofosbuvir, Ribavirin
- Where
- 10 sites in Australia, France
- Volunteers
- 53 people
- Sponsor
- Bristol-Myers Squibb
Compensated Cirrhosis, Nonalcoholic Steatohepatitis
Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)
A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.
- Trial name
- NCT04210245
- Testing
- aldafermin
- Where
- 49 sites in United States, Australia and 7 more
- Volunteers
- 160 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Primary Sclerosing Cholangitis, Compensated Cirrhosis
Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis
The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (CILO) in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.
- Trial name
- NCT04060147
- Testing
- Cilofexor
- Where
- 16 sites in United States
- Volunteers
- 11 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection
This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based…
- Trial name
- GIFT-II (NCT02023112)
- Testing
- ABT-450/r/ABT-267, Ribavirin
- Volunteers
- 171 people
- Sponsor
- AbbVie
Hepatitis C, Chronic
A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis
This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus…
- Trial name
- NCT01749150
- Testing
- danoprevir + ritonavir, peginterferon alfa-2a [Pegasys], ribavirin [Copegus]
- Where
- 13 sites in South Korea, Taiwan and 1 more
- Volunteers
- 61 people
- Sponsor
- Hoffmann-La Roche
Patients With Compensated Liver Cirrhosis
Assessing Portal Hypertension With Methacetin Breath Test
This study will be used to train an algorithm using Methacetin breath test (MBT) measures and to select a cut-off to determine presence or absence of Clinically Significant Portal Hypertension (CSPH) as defined by Hepatic Venous…
- Trial name
- NCT02143778
- Testing
- Methacetin Breath Test
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 246 people
- Sponsor
- Meridian Bioscience, Inc.
Hepatitis C
Early Access Program of Telaprevir With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects
The purpose of this early access program is to provide telaprevir to patients with a specific type of hepatitis C viral infection (termed 'genotype 1') who are expected to benefit from telaprevir-based therapy but who reside in…
- Trial name
- NCT01508286
- Testing
- Telaprevir + peginterferon alfa + ribavirin, peginterferon alfa + ribavirin
- Where
- 128 sites in Australia, Austria and 13 more
- Sponsor
- Janssen-Cilag International NV
Liver Fibrosis, Cirrhosis
Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis
The purpose of this research study is to test the safety and effectiveness of Interferon gamma-1b (IFN-g 1b) injected subcutaneously (under the skin) for the treatment of advanced liver fibrosis and cirrhosis in patients with…
- Trial name
- NCT00043303
- Testing
- interferon gamma-1b
- Volunteers
- 502 people
- Sponsor
- InterMune