Clinical trials: Chronic Liver Disease and Cirrhosis
Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection
A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection
The primary objectives of this study are to assess the safety of ABT-450/r/ABT-267 with and without ABT-333 coadministered with and without ribavirin (RBV) for 12 and 24 weeks in HCV GT1- or 4-infected participants with HIV-1…
- Conditions
- Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection, Chronic Hepatitis C, Compensated Cirrhosis and Non-cirrhotics
- Trial name
- TURQUOISE-I (NCT01939197)
- Testing
- ABT-450/r/ABT-267, ABT-333, ribavirin
- Volunteers
- 318 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
Liver Fibrosis
Liver Fibrosis Assessment With ShearWave Elastography
Chronic liver disease/fibrosis can be the result of various causes, and the result is that the liver tissue becomes stiff. ShearWave™ elastography, available on the Aixplorer® ultrasound system, is a method that can be used to…
- Trial name
- NCT02181452
- Where
- 13 sites in Belgium, China and 7 more
- Volunteers
- 2,333 people
- Sponsor
- SuperSonic Imagine
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
Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant
This trial was open to participants who had received a liver transplant or had cirrhosis due to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were followed for 24 weeks post treatment.
- Trial name
- ALLY 1 (NCT02032875)
- Testing
- Daclatasvir, Sofosbuvir, Ribavirin
- Where
- 5 sites in United States
- Volunteers
- 116 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C Virus Infection
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in adults with chronic hepatitis C virus (HCV)…
- Trial name
- NCT04112303
- Testing
- SOF/VEL
- Where
- 22 sites in Japan
- Volunteers
- 37 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24…
- Trial name
- ASTRAL-4 (NCT02201901)
- Testing
- SOF/VEL, RBV
- Where
- 50 sites in United States, Puerto Rico
- Volunteers
- 268 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection
This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based…
- Trial name
- GIFT-II (NCT02023112)
- Testing
- ABT-450/r/ABT-267, Ribavirin
- Volunteers
- 171 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 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
Liver Fibrosis, Hepatic Fibrosis
A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV
This is a double-blind, multicenter study involving patients with chronic HCV infection who had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete cirrhosis; achieved a sustained virologic response…
- Conditions
- Liver Fibrosis, Hepatic Fibrosis, Liver Cirrhosis, Hepatic Cirrhosis
- Trial name
- POLT-HCV-SVR (NCT02138253)
- Testing
- IDN-6556
- Where
- 35 sites in United States
- Volunteers
- 64 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Hepatitis C Virus Infection
Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants…
- Trial name
- NCT02994056
- Testing
- SOF/VEL, RBV
- Where
- 12 sites in United States, France
- Volunteers
- 32 people
- Sponsor
- Gilead Sciences
Viral Hepatitis B, Viral Hepatitis D
Replicor Compassionate Access Program
The goal of this compassionate access program is to provide early access to REP 2139-Mg for patients with HBV mono-infection or HBV / HDV co-infection who either have advanced (decompensated) cirrhosis or who have failed to…
- Conditions
- Viral Hepatitis B, Viral Hepatitis D, Cirrhosis, Liver, Decompensated Cirrhosis
- Trial name
- RCAP (NCT05683548)
- Testing
- REP 2139-Mg, Tenofovir Disoproxil Fumarate, Pegylated interferon alpha2a
- Where
- 13 sites in Austria, France and 3 more
- Sponsor
- Replicor Inc.
Hepatitis, Hepatitis C, Chronic
PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)
The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed…
- Conditions
- Hepatitis, Hepatitis C, Chronic, Fibrosis, Liver Cirrhosis
- Trial name
- NCT00039871
- Testing
- PegIntron (peginterferon alfa-2b; SCH 54031), REBETOL (ribavirin; SCH 18908)
- Volunteers
- 2,333 people
- Sponsor
- Merck Sharp & Dohme LLC
Liver Fibroses
SWE Liver Stiffness as a Predictor of Progression of Chronic Liver Diseases
This study is a multicenter individual patient-based meta-analysis that will assess the performances of liver stiffness measurements performed with supersonic shear imaging shearwave elastography (SSI-SWE) in patients with liver…
- Trial name
- SWE Predict (NCT03389152)
- Testing
- Elastography
- Volunteers
- 2,148 people
- Sponsor
- SuperSonic Imagine
Hepatitis C Virus Infection
Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with…
- Trial name
- POLARIS-3 (NCT02639338)
- Testing
- SOF/VEL/VOX, SOF/VEL
- Where
- 70 sites in United States, Australia and 6 more
- Volunteers
- 220 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic, Cirrhosis
Adefovir Dipivoxil For The Treatment Of Patients With Chronic Hepatitis B Related Advanced Fibrosis Or Cirrhosis
This 36-month open-label study of adefovir dipivoxil investigates the clinical benefits of the therapy in chronic hepatitis B patients with advanced fibrosis or cirrhosis confirmed with biopsy.
- Conditions
- Hepatitis B, Chronic, Cirrhosis, Fibrosis, Chronic Hepatitis B
- Trial name
- NCT00347009
- Testing
- adefovir dipivoxil
- Where
- 12 sites in Hong Kong, Singapore and 3 more
- Volunteers
- 155 people
- Sponsor
- GlaxoSmithKline
Liver Cirrhosis, Hepatitis C, Chronic
Antiviral Efficacy, Pharmacokinetics and Safety of BILN 2061 ZW in Patients With Cirrhosis and Chronic Hepatitis C
Study to assess the antiviral efficacy, pharmacokinetics, and tolerability of 200 mg BILN 2061 ZW in a polyethylene glycol 400 (PEG 400: ethanol) drinking solution given orally for two days bid to patients with cirrhosis and…
- Trial name
- NCT02226939
- Testing
- BILN 2061 ZW
- Volunteers
- 10 people
- Sponsor
- Boehringer Ingelheim
Hepatitis C, Chronic, Liver Cirrhosis
Inhibition of Disease Progression in Hepatitis C-infected Patients With Compensated Liver Cirrhosis (P03811) (COMPLETED)
The objective of the study is to evaluate the superiority of treatment with PegIntron and Rebetol over no antiviral therapy (control group) in subjects with chronic hepatitis C and type C compensated cirrhosis.
- Trial name
- NCT00811967
- Testing
- PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Volunteers
- 50 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C Virus Infection
Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis
This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV) ± ribavirin (RBV) for 8 weeks in…
- Trial name
- NCT02226549
- Testing
- LDV/SOF, VDV, RBV
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Gilead Sciences