Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection

Study Identifier
M15-582
CT.gov Identifier
NCT02609659
EudraCT Identifier
Not available
EUCTIS ID
Not available
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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
  • ribavirin
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Chronic hepatitis C virus (HCV) infection * Non-cirrhotic subjects * Screening laboratory results showing HCV Genotype 1a (HCV GT1a) infection * HCV treatment-naïve or if treated previously, only with interferon (IFN) or pegylated interferon (pegINF) with or without ribavirin (RBV)
    Exclusion Criteria:
    * Pregnant or breastfeeding women * Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) * HCV genotype of any subtype other than GT1a or unable to subtype * Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN or RBV. Subjects with previous participation in trials of investigational direct-acting antiviral agents (DAAs) may be enrolled if they can produce documentation that they received only placebo. * Current enrollment in another interventional clinical study or receipt of any investigational product within 6 weeks prior to study drug administration.

    Protocol Summary

    This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without Ribavirin (RBV).

    Study Locations

    No locations found.