Clinical trials: Liver Fibroses
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
Primary Biliary Cholangitis
A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA
This study evaluates the safety and efficacy of baricitinib in participants with primary biliary cholangitis (PBC) who do not respond or are unable to take ursodeoxycholic acid (UDCA).
- Trial name
- NCT03742973
- Testing
- Baricitinib
- Where
- 12 sites in United States, Puerto Rico
- Volunteers
- 2 people
- Sponsor
- Eli Lilly and Company
Liver Fibrosis, Hepatitis C Virus
Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED)
This study will assess the repeatability of Magnetic Resonance Elastography (MRE) in both healthy volunteers and Hepatitis C Virus (HCV)-infected patients with fibrosis and lay the groundwork for the validation of MRE as an…
- Trial name
- NCT00896233
- Testing
- MRE
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Liver Cirrhosis
A Study to Compare How Different Substances (Caffeine, Warfarin, Omeprazole, Metoprolol, and Midazolam) Are Handled by the Body of Healthy People and People With Liver Cirrhosis
This study is open to healthy adults and adults with liver cirrhosis. The purpose of this study is to compare how different medicines are handled by the body in people with and without liver cirrhosis.
- Trial name
- NCT05741385
- Testing
- Caffeine, Warfarin sodium, Omeprazole
- Where
- Germany
- Volunteers
- 4 people
- Sponsor
- Boehringer Ingelheim
NASH With Fibrosis
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat ([14C] CRV431).
- Trial name
- NCT05737433
- Testing
- [14C]-rencofilstat 225mg
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hepion Pharmaceuticals, Inc.
Chronic Hepatitis C Infection
Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients With Hepatic Fibrosis
Current treatment of chronic liver disease relies upon removing the primary insult to the liver (e.g., alcohol) or treating the underlying viral infection (HBV, HCV, etc.).
- Trial name
- NCT00854087
- Testing
- Fuzheng Huayu
- Where
- 8 sites in United States
- Volunteers
- 118 people
- Sponsor
- Tarek Hassanein
Sonoelastography, Elastography
Shear Wave Sonoelastography in Pediatric Liver Fibrosis
Reliable methods of evaluating liver fibrosis using noninvasive techniques in the pediatric population are limited and inconclusive.
- Conditions
- Sonoelastography, Elastography, Elastograms, Liver Fibrosis
- Trial name
- NCT02372682
- Testing
- Shear wave sonoelastography
- Where
- United States
- Volunteers
- 171 people, healthy volunteers welcome
- Sponsor
- St. Louis University
Primary Biliary Cholangitis, Primary Biliary Cirrhosis
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy.
- Conditions
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Cholangitis, Cholestasis
- Trial name
- PRONTO-PBC (NCT04604652)
- Testing
- HTD1801 (BUDCA)
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Primary Sclerosing Cholangitis
Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis
- Trial name
- NCT04480840
- Testing
- PLN-74809
- Where
- 60 sites in United States, Australia and 7 more
- Volunteers
- 121 people
- Sponsor
- Pliant Therapeutics, Inc.
Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease
Ultrasound Method to Measure Fibrosis of the Liver in Children
HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate quantitative measurements that can be used to stage liver fibrosis in pediatric patients with chronic liver disease.
- Conditions
- Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease, HCV Coinfection, HBV
- Trial name
- NCT02086708
- Testing
- Shear Wave sonoelastography
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Massachusetts General Hospital
Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic…
- Trial name
- RESOLVE-IT (NCT02704403)
- Testing
- Elafibranor
- Where
- 326 sites in United States, Argentina and 23 more
- Volunteers
- 2,157 people
- Sponsor
- Genfit
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
Cholestasis
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC).
- Trial name
- NCT02966834
- Testing
- GSK2330672
- Where
- 66 sites in United States, Australia and 8 more
- Volunteers
- 147 people
- Sponsor
- GlaxoSmithKline
Hepatitis C
Low-Dose Peginterferon and Ribavirin to Treat Chronic Hepatitis C in Patients Infected With HCV Genotype 2 or 3
This study will examine the effectiveness of low-dose peginterferon and ribavirin therapy for certain patients with chronic hepatitis C-a liver disease that, in some patients, can progress to cirrhosis of the liver, liver cancer…
- Trial name
- NCT00056862
- Testing
- Peginterferon alfa-2a, Ribavirin
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Fatty Liver, Non-Alcoholic Steatohepatitis
A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH
This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18 to 75 years of age, with Non-Alcoholic…
- Conditions
- Fatty Liver, Non-Alcoholic Steatohepatitis, Liver Diseases, Liver Fibroses
- Trial name
- Aramchol_005 (NCT02279524)
- Testing
- Aramchol
- Where
- 78 sites in United States, Chile and 9 more
- Volunteers
- 247 people
- Sponsor
- Galmed Research and Development, Ltd.
Cirrhosis, Hepatic Encephalopathy
FMT in Cirrhosis and Hepatic Encephalopathy
Patients with end stage of liver disease or cirrhosis can develop confusion due to high ammonia and inflammation. This confusion is brought upon by changes in the bacteria in the bowels and may not respond to current standard of…
- Trial name
- NCT03796598
- Testing
- Fecal Microbial transplant Capsules, Fecal Microbial Transplant Enema
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- VA Office of Research and Development
Hepatitis C, Depression
Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment
To determine the effect of an integrated care protocol on antiviral treatment and sustained virologic response (SVR) rates following initiation of direct acting antiviral therapies (DAA) treatments in 2011.
- Conditions
- Hepatitis C, Depression, PTSD, Substance Use Disorder
- Trial name
- NCT02648022
- Testing
- Brief mental health interventions and case management
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- VA Office of Research and Development
Liver Cirrhosis, Biliary
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver…
- Trial name
- COBALT (NCT02308111)
- Testing
- Obeticholic Acid (OCA)
- Where
- 181 sites in United States, Argentina and 29 more
- Volunteers
- 334 people
- Sponsor
- Intercept Pharmaceuticals
Hepatitis C, Chronic
Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243)
The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting.
- Trial name
- PRACTICE (NCT00709059)
- Testing
- PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Volunteers
- 538 people
- Sponsor
- Merck Sharp & Dohme LLC
Non-Alcoholic Fatty Liver Disease
Treatment of Non Alcoholic Fatty Liver Disease With n-3 Fatty Acids
Non alcoholic fatty liver disease (NAFLD) imposes a high and increasing burden on the NHS, yet there is presently no licensed treatment or validated approach to management.
- Trial name
- WELCOME (NCT00760513)
- Testing
- OMACOR
- Where
- United Kingdom
- Volunteers
- 103 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust