A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis

Study Identifier
M16-135
CT.gov Identifier
NCT03089944
EudraCT Identifier
2016-004967-38
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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Scientific Result Summary
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Plain Language Summary
Available Language(s): English, Bulgarian, Czech, Romanian, Russian, Spanish
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Study Details

Medical Condition
  • Hepatitis
    • Study Drug
  • Glecaprevir/Pibrentasvir
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6 infection. * Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000 IU/mL at Screening. * Treatment-naive to any approved or investigational anti-HCV medication. * Participant must be documented as cirrhotic, with a Child-Pugh score of less than or equal to 6.
    Exclusion Criteria:
    * Female participant who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug. * Any current or historical clinical evidence of decompensated cirrhosis. * Positive test result at Screening for hepatitis B surface antigen (HBsAg), HBV deoxyribonucleic acid \> lower limit of quantification (LLOQ) in subjects with isolated positive antibody to hepatitis B core antigen (anti-HBc) (i.e., negative HBsAg and anti-hepatitis B),or anti human immunodeficiency virus antibody (HIV Ab). * HCV genotype performed by the central laboratory during screening indicating co-infection with more than one HCV genotype. * History of suspected or confirmed hepatocellular carcinoma.

    Protocol Summary

    A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.

    Study Locations

    Location
    Status
    Location
    St. Josephs Hosp and Med Ctr /ID# 162762
    Phoenix, Arizona, United States, 85013
    Status
    Not applicable
    Location
    Mayo Clinic Arizona /ID# 162314
    Phoenix, Arizona, United States, 85054
    Status
    Not applicable
    Location
    Liver Wellness Center /ID# 162244
    Little Rock, Arkansas, United States, 72204
    Status
    Not applicable
    Location
    Felizarta /ID# 162295
    Bakersfield, California, United States, 93301
    Status
    Not applicable
    Location
    VA Long Beach Healthcare System /ID# 162298
    Long Beach, California, United States, 90822
    Status
    Not applicable
    Location
    Usc /Id# 162248
    Los Angeles, California, United States, 90033
    Status
    Not applicable
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