Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
Status:
Completed
Trial end date:
2018-09-13
Target enrollment:
Participant gender:
Summary
This study will have two parts as follows:
The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and
confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric
participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days
of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.
The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF
dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the
Treatment Phase with no interruption of study drug administration. The Treatment Phase will
evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in
pediatric participants with genotype 2 or 3 HCV infection, respectively.