ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients

Study Identifier
M11-652
CT.gov Identifier
NCT01464827
EudraCT Identifier
2010-022455-31
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
  • ABT-333
  • ABT-267
  • Ribavirin
  • Ritonavir
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 70 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Males and females 18-70 years old, inclusive * Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control * Chronic hepatitis C virus (HCV), genotype 1 infection * Treatment-naive OR null-responders to previous treatment with pegylated interferon (pegIFN) and ribavirin (at least 12 weeks of treatment and failure to achieve a 2 log10 HCV RNA decrease at Week 12) * 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 and anti-human immunodeficiency virus antibody * Positive screen for drugs and alcohol * Significant sensitivity to any drug * Use of contraindicated or prohibited medications within 1 month of dosing * Abnormal laboratory tests

    Protocol Summary

    This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 57583
    Birmingham, Alabama, United States, 35209
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 55530
    Birmingham, Alabama, United States, 35215
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 55385
    Dothan, Alabama, United States, 36305
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 55500
    Phoenix, Arizona, United States, 85054
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 55382
    Tucson, Arizona, United States, 85724
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 61042
    Bakersfield, California, United States, 93301
    Status
    Not applicable
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