A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C
NCT02161939 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2016-01-29
Summary
The primary objective of this program is to provide DCV for 24 weeks to be given in combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis C recurrence with either advanced fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to \<12 months, therefore, no research hypothesis will be tested and no specific endpoints are defined. However, safety data will be collected throughout the study as well as efficacy data
Conditions
- Chronic Hepatitis C
Interventions
- DRUG
-
Daclatasvir (BMS-790052)
- DRUG
-
Sofosbuvir
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
More Related Trials
-
EU: A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C
NCT02097966 ·Status: NO_LONGER_AVAILABLE
-
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
NCT02349048 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus
NCT01628692 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation
NCT01938625 ·Status: COMPLETED ·Phase: PHASE2
-
An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease
NCT02262728 ·Status: COMPLETED ·Phase: PHASE2
-
Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant
NCT02533934 ·Status: COMPLETED ·Phase: PHASE4
-
Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
NCT02010255 ·Status: COMPLETED ·Phase: PHASE2
-
Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
NCT01938430 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience
NCT02745535 ·Status: COMPLETED ·Phase: PHASE2
-
Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection
NCT01492426 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3
NCT02551861 ·Status: WITHDRAWN ·Phase: PHASE2
-
UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis
NCT01973049 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients
NCT01797848 ·Status: WITHDRAWN ·Phase: PHASE3
-
Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
NCT01125189 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
NCT02600351 ·Status: TERMINATED ·Phase: PHASE3
-
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
NCT02201901 ·Status: COMPLETED ·Phase: PHASE3
-
LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients
NCT02631772 ·Status: COMPLETED ·Phase: PHASE4
-
A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects
NCT00663208 ·Status: COMPLETED ·Phase: PHASE2
-
Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant
NCT02781571 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)
NCT02556086 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
NCT01257204 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection
NCT03487848 ·Status: TERMINATED ·Phase: PHASE2
-
Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus
NCT02098616 ·Status: COMPLETED ·Phase: NA
-
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
NCT02994056 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection
NCT02640157 ·Status: COMPLETED ·Phase: PHASE3