A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects

Study Identifier
M14-748
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English, Dutch, German, Spanish, Spanish
Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Hepatitis
  • Study Drug
  • Ombitasvir/paritaprevir/ritonavir
  • Dasabuvir
  • Ribavirin
  • Ombitasvir mini tablet
  • Paritaprevir mini tablet
  • Ritonavir mini tablet
  • Dasabuvir mini tablet
  • Ribavirin solution
  • Phase
    Phase 2/Phase 3
    Sex
    Female & Male
    Age
    3 - 17 Years

    Protocol Summary

    This was a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in Hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4)-infected pediatric participants of ≥ 3 to 17 years of age.

    Study Locations

    Location
    Status
    Location
    UCSF Benioff Childrens Hosp /ID# 136774
    San Francisco, California, United States, 94158
    Status
    Not applicable
    Location
    Children's Hospital Colorado /ID# 137017
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    University of Florida - Archer /ID# 136830
    Gainesville, Florida, United States, 32610
    Status
    Not applicable
    Location
    Advent Health /ID# 167663
    Orlando, Florida, United States, 32803
    Status
    Not applicable
    Location
    Indiana University /ID# 137015
    Indianapolis, Indiana, United States, 46202
    Status
    Not applicable
    Location
    Boston Childrens Hospital /ID# 137174
    Boston, Massachusetts, United States, 02115
    Status
    Not applicable
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