Clinical trials: Fibrosis, Liver
Primary Biliary Cirrhosis
Use of Fenofibrate for Primary Biliary Cirrhosis
This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.
- Trial name
- NCT00575042
- Testing
- Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of Florida
Cirrhosis, Liver, Portal Hypertension
A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients
This is a randomized single-blind feasibility trial to test the utilization of home blood pressure devices to improve the clinical management of decompensated cirrhosis patients.
- Conditions
- Cirrhosis, Liver, Portal Hypertension, Ascites Hepatic
- Trial name
- WATCH (NCT05928624)
- Testing
- Withings Home Blood Pressure Device and Scale, Standard of Care
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- University of California, San Francisco
Cirrhosis, Liver
Using Data-Driven Implementation Strategies to Improve the Quality of Cirrhosis Care
This Veteran Affairs (VA) Quality Improvement project aims to understand which data-driven implementation strategies promote evidence based practices that improve high-quality care for Veterans with cirrhosis.
- Trial name
- NCT04178096
- Testing
- Quality Improvement Intervention
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- VA Office of Research and Development
Liver Fibrosis Due to NASH
Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants…
- Trial name
- NCT01672866
- Testing
- SIM
- Where
- 68 sites in United States, Belgium and 7 more
- Volunteers
- 222 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis…
- Trial name
- ASTRAL-1 (NCT02201940)
- Testing
- SOF/VEL
- Where
- 80 sites in United States, Belgium and 7 more
- Volunteers
- 741 people
- Sponsor
- Gilead Sciences
Cirrhosis, Portal Hypertension
Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension
This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this…
- Conditions
- Cirrhosis, Portal Hypertension, Non-alcoholic Steatohepatitis
- Trial name
- ENCORE-PH (NCT02960204)
- Testing
- Emricasan
- Where
- 37 sites in United States, Germany and 1 more
- Volunteers
- 263 people
- Sponsor
- Histogen
Hepatocellular Carcinoma, Cirrhosis
Durvalumab (MEDI4736) and Tremelimumab for Hepatocellular Carcinoma in Patients Listed for a Liver Transplant
Immunotherapy can safely downstage patients and achieve durable systemic disease control to improve clinical outcomes in HCC patients undergoing liver transplant.
- Conditions
- Hepatocellular Carcinoma, Cirrhosis, Portal Hypertension
- Trial name
- NCT05027425
- Testing
- Durvalumab, Tremelimumab, Liver Transplant
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- University of Cincinnati
Hepatitis C Virus, Advanced Fibrosis
Study of Long-term Peg Intron vs. Colchicine in Non-responders.
In this study Peg-Intron will be tested to see if it will give better results than Colchicine. At this time, there is currently no recommended maintenance treatment for patients who have failed to respond to…
- Conditions
- Hepatitis C Virus, Advanced Fibrosis, Cirrhosis
- Trial name
- COPILOT (NCT00179413)
- Testing
- PEG -Intron, Colchicine
- Where
- 49 sites in United States
- Volunteers
- 549 people
- Sponsor
- Beth Israel Deaconess Medical Center
Non Alcoholic Steatohepatitis (NASH)
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic…
- Trial name
- REGENERATE (NCT02548351)
- Testing
- Obeticholic Acid
- Where
- 346 sites in United States, Australia and 19 more
- Volunteers
- 2,477 people
- Sponsor
- Intercept Pharmaceuticals
Non-alcoholic Steatohepatitis (NASH)
Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis
The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.
- Trial name
- TANDEM (NCT03517540)
- Testing
- Tropifexor (LJN452), Cenicriviroc (CVC)
- Where
- 65 sites in United States, Argentina and 15 more
- Volunteers
- 193 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis C, Chronic
Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)
The objective of this study is to compare the efficacy of peginterferon alfa-2b (PegIFN-2b) monotherapy administered at a dose of 0.5 ug/kg vs stronger neo minophagen C (SNMC) in participants with chronic hepatitis C (CHC) and…
- Trial name
- NCT00686881
- Testing
- Peginterferon alfa-2b (PegIFN-2b), Comparator: Stronger neo minophagen C (SNMC)
- Volunteers
- 261 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Encephalopathy, Cirrhosis
The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy
The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.
- Trial name
- NCT01842581
- Testing
- Rifaximin, Lactulose
- Where
- 43 sites in United States
- Volunteers
- 222 people
- Sponsor
- Bausch Health Americas, Inc.
Hepatic Cirrhosis, Hepatic Encephalopathy (HE)
MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
The main reason for this study is to see how the study drug interacts with the body. It will compare different doses of the study drug with a drug already in use.
- Trial name
- NCT03712280
- Testing
- MNK6106, Rifaximin
- Where
- 5 sites in United States, Puerto Rico
- Volunteers
- 50 people
- Sponsor
- Mallinckrodt
Nonalcoholic Fatty Liver Disease (NAFLD)
Impact of Fructose on Metabolism, Energy Homeostasis and Magnetic Resonance Biomarkers in Nonalcoholic Fatty Liver Disease
This study will advance several goals of the NIH Action Plan: 1) establish a multidisciplinary team to develop quantitative methodologies and imaging protocols for liver, 2) validate diagnostic criteria and methodologies for…
- Trial name
- NCT01930123
- Testing
- intravenous fructose challenge, Blood Draw
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Manal F Abdelmalek
Hepatorenal Syndrome
Treatment of Type I Hepatorenal Syndrome (HRS) With Pentoxyfylline
Pentoxyfylline therapy in addition to the standard of care of albumin, midodrine and octreotide therapy is superior to the standard of care alone in the treatment of Type I hepatorenal syndrome in the first 14 days of…
- Trial name
- NCT02123576
- Testing
- Pentoxyfylline, AMO Therapy
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Patrick Northup, MD
Hepatitis C Virus Infection
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis
The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with…
- Trial name
- NCT02114151
- Testing
- Simeprevir, Sofosbuvir
- Where
- 34 sites in United States, Canada
- Volunteers
- 103 people
- Sponsor
- Janssen Infectious Diseases BVBA
Compensated Cirrhosis and Portal Hypertension
An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension
The main purpose of this exploratory study was to investigate the effect of serelaxin (RLX030) infusion on the hepatic and renal circulation in patients with compensated cirrhosis and portal hypertension.
- Trial name
- NCT01640964
- Testing
- Terlipressin acetate, Serelaxin (RLX030)
- Where
- United Kingdom
- Volunteers
- 47 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis C, Cirrhosis
Intravenous Interferon During Liver Transplant
The main goal of this study is to prevent liver allograft infection with Hepatitis C virus in hepatitis C positive patients undergoing liver transplantation.
- Trial name
- NCT01192698
- Testing
- IV interferon
- Volunteers
- 15 people
- Sponsor
- Wake Forest University Health Sciences
Nonalcoholic Steatohepatitis
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.
- Trial name
- STELLAR-3 (NCT03053050)
- Testing
- SEL
- Where
- 298 sites in United States, Argentina and 25 more
- Volunteers
- 808 people
- Sponsor
- Gilead Sciences
Non Alcoholic Steatohepatitis, Fibrosis
Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis
This is a randomized, placebo-controlled phase 1/2a study to investigate the safety and tolerability of Idebenone in patients 18 years of age or older with non-alcoholic steatohepatitis, with stage 1-3 fibrosis.
- Trial name
- NCT04669158
- Testing
- Idebenone
- Where
- 2 sites in United States
- Volunteers
- 53 people
- Sponsor
- Stanford University