NCT02175758

Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection

A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	SOF	SOF administered orally once daily
DRUG	RBV	RBV oral solution or capsules will be administered orally in a divided daily dose based on weight

Timeline

• Start date: 2014-07-07
• Primary completion: 2018-06-21
• Completion: 2018-09-13
• First posted: 2014-06-26
• Last updated: 2019-04-30
• Results posted: 2019-04-30

Locations

37 sites across 8 countries: United States, Australia, Belgium, Germany, Italy, New Zealand, Russia, United Kingdom

Regulatory

• FDA-regulated drug study