Clinical trials: Fibrosis, Liver
Hepatitis C Virus
Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
The purpose of this study is to evaluate the efficacy of 6 or 8 weeks of treatment regimen containing simeprevir (SMV), daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naive (not having received treatment with any approved or…
- Trial name
- ACCORDION-1 (NCT02349048)
- Testing
- Simeprevir 150 mg, Daclatasvir 60 mg, Sofosbuvir 400 mg
- Where
- 8 sites in United States, Canada
- Volunteers
- 68 people
- Sponsor
- Janssen Research & Development, LLC
Pruritus
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.
- Trial name
- NCT04950127
- Testing
- Linerixibat
- Where
- 5 sites in Germany, United Kingdom
- Volunteers
- 238 people
- Sponsor
- GlaxoSmithKline
Cholestasis
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects
In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking obeticholic acid (OCA) who experience pruritus (due to primary biliary cholangitis [PBC], OCA, or both) the addition of linerixibat to OCA…
- Trial name
- NCT04053023
- Testing
- GSK2330672 (linerixibat), Obeticholic acid
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Liver Cirrhosis, Biliary
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.
- Trial name
- NCT00550862
- Testing
- INT-747, Ursodeoxycholic Acid (URSO)
- Where
- 32 sites in United States, Austria and 6 more
- Volunteers
- 165 people
- Sponsor
- Intercept Pharmaceuticals
Hepatic Encephalopathy, Cirrhosis
Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy.
This study is being done to find out if the laxative polyethylene glycol (also known as GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver disease and/or cirrhosis) better and/or more safely…
- Conditions
- Hepatic Encephalopathy, Cirrhosis, Portosystemic Encephalopathy, PSE
- Trial name
- PSE (NCT01283152)
- Testing
- Polyethylene glycol 3350-electrolyte solution (GoLYTELY®), Lactulose
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Texas Southwestern Medical Center
Nonalcoholic Steatohepatitis
AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)
The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult participants with NASH.
- Trial name
- AURORA (NCT03028740)
- Testing
- Cenicriviroc
- Where
- 346 sites in United States, Australia and 26 more
- Volunteers
- 1,778 people
- Sponsor
- Tobira Therapeutics, Inc.
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
Hepatic Cirrhosis, Liver Fibrosis
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and liver cirrhosis (liver damage…
- Conditions
- Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis
- Trial name
- FALCON 2 (NCT03486912)
- Testing
- BMS-986036
- Where
- 91 sites in United States, Japan
- Volunteers
- 155 people
- Sponsor
- Bristol-Myers Squibb
Cirrhosis, End Stage Liver Disease
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies).
- Conditions
- Cirrhosis, End Stage Liver Disease, Acute Kidney Injury, Liver Transplant; Complications
- Trial name
- MHALT (NCT03534141)
- Testing
- Esophageal cooling/warming device, Mild hypothermia, Normothermia
- Where
- 3 sites in United States
- Volunteers
- 175 people
- Sponsor
- University of California, San Francisco
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
Portal Hypertension, Liver Fibroses
Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness
Pilot study examining changes in liver stiffness measured by ultrasound before and after TIPS creation
- Trial name
- NCT03352882
- Testing
- Ultrasound
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Pennsylvania
Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis…
- Trial name
- NCT04048876
- Testing
- CC-90001
- Where
- 142 sites in United States, Australia and 8 more
- Volunteers
- 56 people
- Sponsor
- Celgene
Liver Cirrhosis
Adult Stem Cell Therapy in Liver Insufficiency
In order to determine the clinical application potential of adult stem cells we propose to investigate the safety and toxicity of infusing adult stem cells in the hepatic artery or portal vein of five patients with chronic liver…
- Trial name
- NCT00147043
- Testing
- Leukapheresis, Infusion of stem cells via image guided scan
- Where
- United Kingdom
- Volunteers
- 5 people
- Sponsor
- Imperial College London
PBC, Primary Biliary Cirrhosis
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with…
- Trial name
- CLARITY (NCT01904058)
- Testing
- LUM001, Ursodeoxycholic Acid
- Where
- 24 sites in United States, Canada and 1 more
- Volunteers
- 66 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cirrhosis
Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA) treatment, and have persistently high…
- Trial name
- NCT03226067
- Testing
- GKT137831
- Where
- 61 sites in United States, Belgium and 7 more
- Volunteers
- 111 people
- Sponsor
- Calliditas Therapeutics AB
Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients…
- Conditions
- Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis, Cirrhosis
- Trial name
- NAVIGATE (NCT04365868)
- Testing
- belapectin
- Where
- 156 sites in United States, Argentina and 13 more
- Volunteers
- 357 people
- Sponsor
- Galectin Therapeutics Inc.
Hepatitis C Virus Infection
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection
The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to…
- Trial name
- ASTRAL-3 (NCT02201953)
- Testing
- SOF/VEL, SOF, RBV
- Where
- 76 sites in United States, Australia and 7 more
- Volunteers
- 558 people
- Sponsor
- Gilead Sciences
Liver Cirrhosis, Biliary
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment…
- Trial name
- NCT03633227
- Testing
- Obeticholic Acid (OCA)
- Where
- 40 sites in United States, Argentina and 10 more
- Volunteers
- 22 people
- Sponsor
- Intercept Pharmaceuticals
Hepatorenal Syndrome
A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin
This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.
- Trial name
- NCT01143246
- Testing
- Terlipressin
- Where
- 73 sites in United States, Canada
- Volunteers
- 196 people
- Sponsor
- Mallinckrodt
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