A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection

Study Identifier
M13-961
CT.gov Identifier
NCT01767116
EudraCT Identifier
2012-003687-52
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
  • ABT-450/r/ABT-267, ABT-333
  • Ribavirin
  • Placebo for ribavirin
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 70 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile * Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening) * Subject has never received antiviral treatment for hepatitis C infection * No evidence of liver cirrhosis
    Exclusion Criteria:
    * Significant liver disease with any cause other than HCV as the primary cause * Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody * Positive screen for drugs or alcohol * Significant sensitivity to any drug * Use of contraindicated medications within 2 weeks of dosing * Abnormal laboratory tests

    Protocol Summary

    The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.

    Study Locations

    No locations found.