Clinical trials: Compensated Liver Cirrhosis
Non-alcoholic Steatohepatitis, Fatty Liver
An Evaluation of the Safety and Efficacy of Nitazoxanide on Collagen Turnover in NASH Patients With Fibrosis
To evaluate the safety and tolerability of Nitazoxanide (NTZ) 500mg Twice Daily (BID) after 24 weeks of treatment in patients with NASH induced Stage 2 or Stage 3 fibrosis
- Conditions
- Non-alcoholic Steatohepatitis, Fatty Liver, Fibrosis, Liver, Compensated Cirrhosis
- Trial name
- NCT03656068
- Testing
- Nitazoxanide 500mg BID
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Pinnacle Clinical Research, PLLC
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
Chronic Hepatitis C Virus (HCV) Infection Genotype 1
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic…
- Trial name
- TOPAZ-II (NCT02167945)
- Testing
- ABT-450/r/ABT-267, ABT-333, Ribavirin (RBV)
- Where
- 48 sites in United States
- Volunteers
- 615 people
- Sponsor
- AbbVie
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
Hepatitis C Virus (HCV)
A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection
The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in…
- Trial name
- DORA (NCT03067129)
- Testing
- Glecaprevir/Pibrentasvir Adult Formulation, Glecaprevir + Pibrentasvir Pediatric Formulation
- Where
- 38 sites in United States, Belgium and 7 more
- Volunteers
- 129 people
- Sponsor
- AbbVie
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
Chronic Hepatitis C, Hepatitis C Virus
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an…
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis, Severe Renal Impairment
- Trial name
- NCT02207088
- Testing
- ombitasvir/paritaprevir/ritonavir, dasabuvir, Ribavirin
- Volunteers
- 68 people
- Sponsor
- AbbVie
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
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.
Chronic Hepatitis C
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir
The purpose of this study is to evaluate the safety and tolerability of AL-335 in combination with odalasvir (ODV) with or without simeprevir (SMV) in participants with genotype (GT)1 or GT2 or GT3 chronic hepatitis C (CHC)…
- Trial name
- NCT02569710
- Testing
- AL-335, Odalasvir (ODV), Simeprevir (SMV)
- Where
- 11 sites in Mauritius, Moldova and 2 more
- Volunteers
- 161 people
- Sponsor
- Alios Biopharma Inc.
Chronic Hepatitis C Infection, Compensated Cirrhosis
A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis
The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir)…
- Trial name
- TURQUOISE-II (NCT01704755)
- Testing
- ABT-450/r/ABT-267, ABT-333, Ribavirin (RBV)
- Volunteers
- 381 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Hepatitis C Virus Infection, Chronic Hepatitis C
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis
The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.
- Conditions
- Hepatitis C Virus Infection, Chronic Hepatitis C, Compensated Cirrhosis
- Trial name
- EXPEDITION-1 (NCT02642432)
- Testing
- ABT-493/ABT-530
- Volunteers
- 146 people
- Sponsor
- AbbVie
NASH - Nonalcoholic Steatohepatitis
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.
- Trial name
- NCT05039450
- Testing
- EFX
- Where
- 49 sites in United States, Mexico and 1 more
- Volunteers
- 213 people
- Sponsor
- Akero Therapeutics, Inc
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
Chronic Hepatitis C Infection, Compensated Cirrhosis
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis
The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.
- Trial name
- TURQUOISE-III (NCT02219503)
- Testing
- Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir
- Volunteers
- 60 people
- Sponsor
- AbbVie
Chronic Hepatitis C
Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir (r) - Ombitasvir, + Dasabuvir Without Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis in the Russian Federation
This prospective, multi-center, observational study is designed to assess the real world effectiveness of paritaprevir/r - ombitasvir with dasabuvir (3DAA [direct-acting antiviral agent] ABBVIE REGIMEN) without ribavirin (RBV)…
- Trial name
- CITRIN (NCT03053180)
- Where
- 7 sites in Russia
- Volunteers
- 60 people
- Sponsor
- AbbVie
Cirrhosis, Aerobic Exercises
The Efficacy of Aerobic Exercise Training on ANS and Endothelial Function in Compensated Cirrhosis
The goal of this randomized controlled trial is to investigate whether a 16-week structured aerobic exercise program combined with nutritional consultation can improve autonomic and endothelial function in patients with…
- Conditions
- Cirrhosis, Aerobic Exercises, Lifestyle Modification, Endothelial Function
- Trial name
- NCT06288828
- Testing
- Aerobic exercise + Nutrition consultant, Nutrition consultant
- Where
- Thailand
- Volunteers
- 50 people
- Sponsor
- King Chulalongkorn Memorial Hospital
Hepatitis C, Chronic, Liver Cirrhosis
Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116)
The objective is to evaluate the efficacy and safety of combination therapy with peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks in participants with chronic hepatitis C and type C…
- Trial name
- NCT00687219
- Testing
- Peginterferon alfa-2b, Ribavirin
- Volunteers
- 102 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Liver Cirrhosis
Open Label Single Dose Phase I Trial of BI 201335 to Study Pharmacokinetics and Safety in Patients With Compensated Liver Cirrhosis
This trial was intended to investigate the pharmacokinetics, safety and tolerability of BI 201335 NA soft-gel capsules in patients with compensated liver cirrhosis, i.e. grade A according to Child-Pugh classification (< 7 points).
- Trial name
- NCT01909778
- Testing
- BI 201335
- Where
- Germany
- Volunteers
- 2 people
- Sponsor
- Boehringer Ingelheim
Hepatitis C Virus (HCV)
A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate…
- Trial name
- EXPEDITION-8 (NCT03089944)
- Testing
- Glecaprevir/Pibrentasvir
- Where
- 113 sites in United States, Bulgaria and 17 more
- Volunteers
- 343 people
- Sponsor
- AbbVie