A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection

Study Identifier
M14-224
CT.gov Identifier
NCT02356562
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Hepatitis
    • Study Drug
  • ombitasvir/paritaprevir/ritonavir and dasabuvir
  • Sofosbuvir
  • Ribavirin
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * History of previous direct acting antiviral (DAA) therapy failure; Part 2 only: history of previous direct acting antiviral (DAA) therapy failure and received at least 8 weeks of SOF/ledipasvir; participant must be treatment naïve to all other anti-HCV therapies * HCV genotype 1 infection * Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
    Exclusion Criteria:
    * Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody * Discontinuation of the prior DAA treatment for reasons other than virologic failure * Confirmed presence of hepatocellular carcinoma * Abnormal lab tests

    Protocol Summary

    The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir (SOF) and ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus infection. This study will contain 2 parts.

    Part 1: Approximately 20 participants and at least 10 of the 20 participants previously treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without RBV, and experienced treatment failure.

    Part 2: Approximately 10 participants and all participants previously treated with SOF/ledipasvir and experienced treatment failure.

    Study Locations

    No locations found.