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
Study Drug
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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