Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to provide anti-HCV drugs to +/- 200 subjects treated in prior BMS studies with placebo + Peginterferon Alfa-2a and Ribavirin and determine if the addition of these drugs can result in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b subjects rolling over from BMS study AI447-028 who received placebo will be treated with active drugs in this study.


Clinical Trial Description

- Intervention Model:

- Parallel: for all subjects entering the trial

- Cross-over: for genotype 1b subjects rolling over from AI447-028 who require rescue therapy after initial treatment in this study

- Peginterferon Alfa-2a (pegIFNα-2a)

- Ribavirin (RBV)

- Daclatasvir (DCV)

- Asunaprevir (ASV) ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01428063
Study type Interventional
Source Bristol-Myers Squibb
Contact
Status Completed
Phase Phase 2
Start date September 2011
Completion date December 2014

See also
  Status Clinical Trial Phase
Completed NCT02907996 - Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
Completed NCT02207088 - Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease Phase 3
Not yet recruiting NCT02893046 - HCV Care Pathway in Ile-de-France N/A
Completed NCT01396005 - A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123) Phase 1
Completed NCT01195181 - Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice. Phase 4
Completed NCT00219999 - Hepatitis C Virus and the Humoral Immune System N/A
Completed NCT02243293 - A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection Phase 2/Phase 3
Completed NCT02265237 - A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1) Phase 3
Not yet recruiting NCT06104046 - Prevalence of Seroconversion of Hepatitis c Virus Among Children With CKD on Regular Hemodialysis
Completed NCT02604017 - A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection Phase 3
Withdrawn NCT00947245 - Japanese Bridging Study Conducted in the United States Phase 1
Completed NCT01713283 - Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection Phase 2
Completed NCT01458535 - A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-267 and With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Phase 2
Completed NCT01479881 - A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus Phase 1
Completed NCT01193361 - Ph IIA Study (SOC +/- NS5B) Phase 2
Completed NCT01241773 - TMC435-TiDP16-C123 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents Efavirenz and Raltegravir Phase 1
Completed NCT01006031 - Retreatment With High Doses of pegIFN Alfa-2a and Ribavirin of Previous Nonresponders HIV-coinfected Patients With Cirrhosis Due to HCV 1-4 Phase 2/Phase 3
Completed NCT00819026 - Observational Trial of Hepatitis C Virus Infected Patients on Calcineurin Inhibitors N/A
Completed NCT00382798 - Adaptive Phase I HCV Study With Nucleoside Analogue, in Combination With Interferon and Ribavirin Phase 1/Phase 2
Completed NCT02592057 - Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India