A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection

Study Identifier
M16-123
CT.gov Identifier
NCT03067129
EudraCT Identifier
2016-004102-34
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
Download document(s)
Statistical Analysis Plan
Available Language(s): English
Download document(s)
Scientific Result Summary
Available Language(s): English
Download document(s)
Plain Language Summary
Available Language(s): English, Dutch (Belgium), German, Japanese, Russian, Spanish
Download document(s)

Study Details

Medical Condition
  • Hepatitis
    • Study Drug
  • Glecaprevir/Pibrentasvir Adult Formulation
  • Glecaprevir + Pibrentasvir Pediatric Formulation
    • Phase
    Phase 2/Phase 3
    Sex
    Female & Male
    Age
    3 - 17 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Hepatitis C virus (HCV) infection demonstrated by positive anti-HCV antibody (Ab) and HCV ribonucleic acid (RNA) greater than or equal to 1000 International Unit (IU)/mL * Subjects participating in the intense pharmacokinetic (IPK) part must have been HCV treatment-naive, with or without compensated cirrhosis (Child-Pugh A), human immunodeficiency virus type 1 (HIV-1) negative and must have had a Screening laboratory result indicating HCV genotype (GT) 1, 2, 3, 4, 5, or 6-infection.
    Exclusion Criteria:
    * Females who were pregnant or breastfeeding * Positive test result for hepatitis B surface antigen (HbsAg) or positive test result for hepatitis B virus deoxyribonucleic acid (DNA) * Participants with other known liver diseases * Decompensated cirrhosis defined as: presence of ascites, history of variceal bleeding, lab values consistent with Child-Pugh class B or C cirrhosis

    Protocol Summary

    The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in children ages 3 to \< 12 years.

    Study Locations

    Location
    Status
    Location
    Univ of California San Francis /ID# 158002
    San Francisco, California, United States, 94158
    Status
    Not applicable
    Location
    Childrens Hospital Colorado /ID# 157996
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    CT Childrens Medical Ctr, US /ID# 158639
    Hartford, Connecticut, United States, 06106
    Status
    Not applicable
    Location
    UF Hepatology Research at CTRB /ID# 158008
    Gainesville, Florida, United States, 32610-0272
    Status
    Not applicable
    Location
    Advent Health /ID# 166022
    Orlando, Florida, United States, 32803
    Status
    Not applicable
    Location
    Indiana University /ID# 158001
    Indianapolis, Indiana, United States, 46202
    Status
    Not applicable
    Showing {first} - {last} of {total} Results