A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Study Identifier
M14-222
CT.gov Identifier
NCT02167945
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Plain Language Summary
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Scientific Result Summary
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Study Details

Medical Condition
  • Hepatitis
    • Study Drug
  • ABT-450/r/ABT-267
  • ABT-333
  • Ribavirin (RBV)
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control 2. Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 1,000 IU/mL at screening) 3. HCV genotype 1 infection per screening laboratory result
    Exclusion Criteria:
    1. Use of contraindicated medications within 2 weeks of dosing 2. Abnormal laboratory tests 3. Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody 4. History of solid organ transplant, clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation 5. Presence of hepatocellular carcinoma at screening

    Protocol Summary

    The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.

    Study Locations

    Location
    Status
    Location
    St. Josephs Hospital and Med Center /ID# 127800
    Phoenix, Arizona, United States, 85013
    Status
    Not applicable
    Location
    Franco Felizarta, Md /Id# 126569
    Bakersfield, California, United States, 93301
    Status
    Not applicable
    Location
    Ruane Clinical Research Group /ID# 126577
    Los Angeles, California, United States, 90036
    Status
    Not applicable
    Location
    California Pacific Medical Center /ID# 128681
    San Francisco, California, United States, 94115
    Status
    Not applicable
    Location
    Univ of Colorado Cancer Center /ID# 126568
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    Medstar Health Research Institute /ID# 128683
    Washington D.C., District of Columbia, United States, 20010
    Status
    Not applicable
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