Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

Study Identifier
M12-114
CT.gov Identifier
NCT01314261
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
  • ABT-267
  • Pegylated interferon (pegIFN)
  • Ribavirin (RBV)
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Treatment naïve participants * Females must be either postmenopausal for at least 2 years or surgically sterile * Males must be surgically sterile or practicing specific forms of birth control * Chronic hepatitis C virus (HCV), genotype-1 infected participants * Documented FibroTest score in combination with an Aspartate Aminotransferase to Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document absence of cirrhosis
    Exclusion Criteria:
    * Pregnant or breastfeeding female * Use of any medications contraindicated for use with pegylated interferon(pegIFN) or ribavirin (RBV) 2 weeks prior to study drug administration or 10 half-lives, whichever is longer * Clinically significant cardiac, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic disease, or any uncontrolled medical illness or psychiatric disease or disorder * Current or past clinical evidence of cirrhosis or bridging fibrosis * Abnormal screening laboratory results

    Protocol Summary

    The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected participants.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 56623
    Birmingham, Alabama, United States, 35215
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 48476
    Los Angeles, California, United States, 90048
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 51345
    Orlando, Florida, United States, 32809
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 51498
    Honolulu, Hawaii, United States, 96814
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 48473
    Indianapolis, Indiana, United States, 46202
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 52782
    Kansas City, Missouri, United States, 64131
    Status
    Not applicable
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