A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil

Study Identifier
M14-225
CT.gov Identifier
NCT02442271
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
  • ribavirin
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control * Males must be surgically sterile or agree to practice acceptable forms of birth control * Chronic hepatitis C virus (HCV) infection at screening * Fibrosis stage F3 or greater, documented by acceptable tests * Participants with cirrhosis: Absence of hepatocellular carcinoma (HCC) as indicated by acceptable methods
    Exclusion Criteria:
    * Women who are pregnant or breastfeeding * Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody positive (HIV Ab) * Use of contraindicated medications within 2 weeks of dosing * Clinically significant abnormalities or co-morbidities * History of solid organ transplant * Abnormal laboratory tests * Current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation

    Protocol Summary

    The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.

    Study Locations

    No locations found.