Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV
NCT01866930 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 453
Last updated 2023-06-13
Summary
To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1
Conditions
- Chronic Hepatitis C Infection
Interventions
- BIOLOGICAL
-
Pegylated Interferon Lambda-1a
- DRUG
-
Daclatasvir (DCV)
- DRUG
-
Ribasphere (RBV)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-07-11
- Primary Completion
- 2015-08-27
- Completion
- 2015-08-27
Countries
- United States
- Argentina
- Belgium
- Canada
- France
- Germany
- Italy
- Mexico
- Poland
- Russia
- Spain
- United Kingdom
Study Locations
More Related Trials
-
Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus
NCT01628692 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C
NCT01754974 ·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NCT01797848 ·Status: WITHDRAWN ·Phase: PHASE3
-
Safety and Efficacy Study of Daclatasvir (BMS-790052) Plus Pegylated Interferon-Alfa 2a and Ribavirin in Patients Coinfected With Untreated Hepatitis C Virus and HIV Virus
NCT01471574 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
NCT01598090 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
NCT01741545 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluating the Safety and Effectiveness of Interferon-Free Treatment of Hepatitis C Virus Infection in HIV-Coinfected Adults on Antiretroviral Therapy
NCT02194998 ·Status: TERMINATED ·Phase: PHASE2
-
Chronically-infected HCV Genotype 2 and 3 Treatment-naive Subjects: Part A: Safety and Efficacy of INX-08189 With Peg IFN Alfa-2a and Ribavirin. Part B: INX-08189 in Interferon Free Treatment With Daclatasvir and/or Ribavirin
NCT01425970 ·Status: TERMINATED ·Phase: PHASE2
-
Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants
NCT01180790 ·Status: COMPLETED ·Phase: PHASE2
-
Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
NCT01257204 ·Status: COMPLETED ·Phase: PHASE2
-
PEG-Interferon a-2b + Ribavirin for Treatment of Chronic HRN 005 Hepatitis C Infection in HIV-Infected Persons Not Previously Treated With Interferon
NCT00215891 ·Status: COMPLETED ·Phase: PHASE3
-
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
-
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
-
A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected With Both HIV and Hepatitis C Virus (HCV)
NCT00008463 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
NCT01125189 ·Status: COMPLETED ·Phase: PHASE2
-
Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
NCT01987453 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care
NCT01012895 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Setrobuvir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Genotype 1 Chronic Hepatitis C
NCT01903954 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy of Pegylated Interferon Plus Ribavirin Plus Nitazoxanide in HCV Genotype 4 and HIV Coinfection
NCT01529073 ·Status: UNKNOWN ·Phase: PHASE2
-
BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C
NCT01389323 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
NCT01846832 ·Status: COMPLETED ·Phase: PHASE3
-
CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Non-Responder (Null And Partial Responder) Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
NCT00277238 ·Status: COMPLETED ·Phase: PHASE2
-
Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (ANRS HC32 QUATTRO)
NCT02107365 ·Status: COMPLETED ·Phase: PHASE2
-
Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials
NCT01428063 ·Status: COMPLETED ·Phase: PHASE2
-
Interest of Ribavirin in the Maintenance Treatment of Liver Fibrosis Using Low Dose Pegylated Interferon alpha2b in Patients With Chronic Hepatitis C Non Responders to Previous Antiviral Therapy.
NCT00323804 ·Status: COMPLETED ·Phase: PHASE2/PHASE3