Clinical trials: Cirrhosis
Cirrhosis, Hepatic Encephalopathy
A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy
This is a phase 2 study of HPN-100 in subjects with hepatic encephalopathy (HE) consisting of an open label safety lead-in (Part A), followed by randomized, double-blind, placebo-controlled treatment (Part B).
- Trial name
- HALT-HE (NCT00999167)
- Testing
- HPN-100
- Where
- 28 sites in United States
- Volunteers
- 189 people
- Sponsor
- Amgen
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT04594694
- Testing
- Obeticholic acid, Bezafibrate 200 MG, Bezafibrate 400 MG
- Where
- 33 sites in Australia, Belgium and 15 more
- Volunteers
- 75 people
- Sponsor
- Intercept Pharmaceuticals
Compensated Cirrhosis, Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
- Trial name
- REVERSE (NCT03439254)
- Testing
- Obeticholic acid (10 mg), Obeticholic acid (10 mg to 25 mg)
- Where
- 192 sites in United States, Australia and 10 more
- Volunteers
- 919 people
- Sponsor
- Intercept Pharmaceuticals
Chronic Hepatitis C, Liver Fibrosis
Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)
The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no treatment for the prevention of fibrosis progression in adult participants with moderate to severe liver fibrosis secondary to chronic…
- Trial name
- NCT00049842
- Testing
- peginterferon alfa-2b (SCH 54031)
- Volunteers
- 540 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C Virus Infection
Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with…
- Trial name
- NCT02996682
- Testing
- SOF/VEL, RBV
- Where
- 33 sites in Japan
- Volunteers
- 102 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C, Hepatitis C Virus
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection
This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with Genotype 1 hepatitis C virus infection without cirrhosis
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, HCV
- Trial name
- NCT02604017
- Testing
- ABT-493/ABT-530
- Volunteers
- 703 people
- Sponsor
- AbbVie
Liver Fibrosis, Cirrhosis
FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis
This prospective and multicenter study is to determine the diagnostic performance (accuracy, specificity and sensitivity) of transient elastography (FibroTouch) for liver fibrosis assessment in chronic hepatitis B (CHB) patients…
- Conditions
- Liver Fibrosis, Cirrhosis, Chronic Hepatitis B
- Trial name
- NCT02476695
- Testing
- FibroTouch Examination, FibroScan Examination, Ultrasonic B Examination
- Where
- 15 sites in China
- Volunteers
- 412 people
- Sponsor
- Wuxi Hisky Medical Technology Co Ltd
Hepatitis C, Cirrhosis
Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection.
- Conditions
- Hepatitis C, Cirrhosis, Portal Hypertension, With or Without Liver Decompensation
- Trial name
- NCT01687257
- Testing
- SOF, RBV
- Where
- 9 sites in United States, Australia and 3 more
- Volunteers
- 50 people
- Sponsor
- Gilead Sciences
Hepatitis, Hepatitis B, Chronic
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the…
- Conditions
- Hepatitis, Hepatitis B, Chronic, Cirrhosis
- Trial name
- NCT00076336
- Testing
- Telbivudine, Lamivudine
- Where
- 28 sites in United States, Australia and 19 more
- Volunteers
- 232 people
- Sponsor
- Novartis Pharmaceuticals
Decompensated Cirrhosis
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-17
This study is a companion protocol that will use the data generated by Conatus' study of emricasan under protocol IDN-6556-17.The IDN-6556-17 study is a Phase 2, multicenter, double-blind, placebo-controlled trial of Emricasan in…
- Trial name
- NCT03462576
- Testing
- Methacetin Breath Test, Emricasan
- Where
- United States
- Volunteers
- 199 people
- Sponsor
- Meridian Bioscience, Inc.
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
Hepatitis C Virus (HCV)
A Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection
This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (GLE)/pibrentasvir (PIB) for an 8 or 12-week treatment duration in adults in Brazil with chronic hepatitis C virus (HCV)…
- Trial name
- NCT03219216
- Testing
- Glecaprevir/Pibrentasvir
- Where
- 14 sites in Brazil
- Volunteers
- 100 people
- Sponsor
- AbbVie
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
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
Hypertension, Portal
Clinical Trial to Evaluation the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients With Nash Cirrhosis
Study GT 026 is a Phase 2, multicenter, parallel group, North American, randomized, placebo controlled, double blind study. This study will enroll subjects with portal hypertension (HVPG greater than or equal to 6 mm Hg) who also…
- Trial name
- NASH-CX (NCT02462967)
- Testing
- GR-MD-02
- Where
- 46 sites in United States
- Volunteers
- 162 people
- Sponsor
- Galectin Therapeutics Inc.
Hepatitis C Virus Infection
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and SOF/VEL FDC and ribavirin (RBV) for 12 weeks in participants with…
- Trial name
- NCT02781558
- Testing
- SOF/VEL, RBV
- Where
- 28 sites in Spain
- Volunteers
- 204 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks compared to treatment with sofosbuvir (SOF)…
- Trial name
- ASTRAL-2 (NCT02220998)
- Testing
- SOF/VEL, SOF, RBV
- Where
- 51 sites in United States, Puerto Rico
- Volunteers
- 269 people
- Sponsor
- Gilead Sciences
Decompensated Cirrhosis and Ascites
Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites
This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in participants…
- Trial name
- PRECIOSA (NCT03451292)
- Testing
- Albutein 20%, SMT
- Where
- 66 sites in United States, Belgium and 12 more
- Volunteers
- 410 people
- Sponsor
- Grifols Therapeutics LLC
Chronic Hepatitis C Virus, Hepatitis C Virus
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection
The purpose of this phase 3, multicenter study is to evaluate the efficacy and safety of ABT-493/ABT-530 in Japanese adults with chronic Hepatitis C Virus (HCV)-infected, HCV direct-acting antiviral agent (DAA) treatment-naïve…
- Trial name
- CERTAIN-1 (NCT02707952)
- Testing
- ABT-493/ABT-530, OBV/PTV/r
- Volunteers
- 295 people
- Sponsor
- AbbVie
Primary Biliary Cirrhosis
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
- Trial name
- NCT01389973
- Testing
- ustekinumab 90 mg, ustekinumab 45 mg, ustekinumab 180 mg
- Where
- 10 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Janssen Research & Development, LLC