A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults

Study Identifier
M15-684
CT.gov Identifier
NCT02582632
EudraCT Identifier
2015-003370-33
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
  • dasabuvir
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 100 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. Chronic HCV infection at Screening. 2. Screening laboratory result indicating HCV genotype 1b infection. 3. Treatment-naïve and non-cirrhotic.
    Exclusion Criteria:
    1. HCV genotype or subtype other than GT1b. 2. Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test. 3. Any current or past clinical evidence of cirrhosis. 4. Screening laboratory analyses that shows abnormal results. 5. Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.

    Protocol Summary

    This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV).

    Study Locations

    No locations found.