Clinical trials: Compensated Cirrhosis
Primary Biliary Cholangitis, Compensated Cirrhosis
A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis.
A Trial to Investigate the Pharmacokinetics (PK) Effects and Safety Profile of K-808 (Pemafibrate) in Primary Biliary Cholangitis (PBC) Subjects with and without Cirrhosis.
- Trial name
- NCT06525311
- Testing
- K-808
- Where
- 10 sites in United States, Japan
- Volunteers
- 17 people
- Sponsor
- Kowa Research Institute, Inc.
Liver Cirrhosis
A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)
This study is open to adults with a type of confirmed liver condition called compensated cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH).
- Trial name
- NCT07325526
- Testing
- BI 3802876
- Where
- 27 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Boehringer Ingelheim
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
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 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
Metabolic Dysfunction-associated Steatohepatitis
A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
- Trial name
- NEBULA-1 (NCT07701993)
- Testing
- Efimosfermin alfa
- Where
- 15 sites in United States, Japan
- Volunteers
- 1,740 people
- Sponsor
- GlaxoSmithKline
Metabolic Dysfunction-associated Steatohepatitis
A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH.
- Trial name
- NEBULA-2 (NCT07704892)
- Testing
- Efimosfermin alfa
- Where
- 20 sites in United States, Japan
- Volunteers
- 380 people
- Sponsor
- GlaxoSmithKline
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated…
- Trial name
- NCT06920043
- Testing
- Efimosfermin
- Where
- 30 sites in United States
- Volunteers
- 42 people
- Sponsor
- GlaxoSmithKline
HCV, Hepatitis C Infection
Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt
This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.
- Conditions
- HCV, Hepatitis C Infection, Genotype 4
- Trial name
- NCT02247401
- Testing
- 2 DAA, RBV
- Volunteers
- 160 people
- Sponsor
- AbbVie
Hepatitis C Virus (HCV)
A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection and Renal Impairment
This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection…
- Trial name
- EXPEDITION-5 (NCT03069365)
- Testing
- Glecaprevir/pibrentasvir
- Where
- 38 sites in United States, Canada and 8 more
- Volunteers
- 101 people
- Sponsor
- AbbVie
Hepatitis C Virus (HCV)
A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6…
- Trial name
- ENDURANCE-5 6 (NCT02966795)
- Testing
- Glecaprevir/Pibrentasvir
- Where
- 25 sites in United States, Australia and 7 more
- Volunteers
- 84 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
Primary Biliary Cholangitis, Compensated Cirrhosis
An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Participants with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
- Conditions
- Primary Biliary Cholangitis, Compensated Cirrhosis, Hepatic Impairment
- Trial name
- NCT04950764
- Testing
- Seladelpar
- Where
- 20 sites in United States, South Korea and 2 more
- Volunteers
- 24 people
- Sponsor
- Gilead Sciences
Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)
Researchers are looking for ways to treat a type of liver disease caused by elevated liver fat, called metabolic dysfunction-associated steatohepatitis (MASH). MASH was formerly called non-alcoholic steatohepatitis (NASH).
- Conditions
- Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, NAFLD, Metabolic Dysfunction-associated Steatotic Liver Disease
- Trial name
- NCT06465186
- Testing
- Efinopegdutide
- Where
- 68 sites in United States, Australia and 9 more
- Volunteers
- 85 people
- Sponsor
- Merck Sharp & Dohme LLC
NASH - Nonalcoholic Steatohepatitis
PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis
This is an open-label, single-dose study to evaluate the PK profile of the liquid SC formulation of BIO89-100 in approximately 8 male and female subjects with NASH with compensated cirrhosis.
- Trial name
- NCT05022693
- Testing
- BIO89-100
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- 89bio, Inc.
Hepatitis C
Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy
An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan
- Trial name
- NCT03071133
- Where
- Japan
- Volunteers
- 344 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis C, Hepatitis C Virus
A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)
The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of ABT-493 and ABT-530 in adults with genotype 1 HCV.
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis
- Trial name
- NCT01995071
- Testing
- ABT-493, ABT-530, ABT-450/r/ABT-267, ABT-333
- Volunteers
- 89 people
- Sponsor
- AbbVie
Liver Fibrosis Due to NASH
Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH
The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH).
- Trial name
- NASH (NCT01672879)
- Testing
- SIM
- Where
- 59 sites in United States, Canada and 6 more
- Volunteers
- 259 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection
A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)
The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection.
- Conditions
- Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection, Chronic Hepatitis C, Compensated Cirrhosis and Non-cirrhotics
- Trial name
- EXPEDITION-2 (NCT02738138)
- Testing
- ABT-493 coformulated with ABT-530
- Volunteers
- 153 people
- Sponsor
- AbbVie
Liver Fibrosis, Hepatic Cirrhosis
A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis.
The purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo in participants with liver fibrosis and compensated cirrhosis.
- Trial name
- BORANA (NCT06750276)
- Testing
- AZD2389
- Where
- 9 sites in United States, Puerto Rico and 1 more
- Volunteers
- 40 people
- Sponsor
- AstraZeneca