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

Completed · Phase 2

Conditions studied: Hepatitis C Virus Infection

In brief

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.

Key facts

Study ID

NCT02175758

Run by

Gilead Sciences

People needed

106

Starts

2014-07-07

Expected to finish

2018-09-13

Last updated by the study team

2019-04-30

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Study site — Moscow, Russia
• Study site — Novokuznetsk, Russia
• Study site — Saint Petersburg, Russia
• Study site — Tolyatti, Russia
• Study site — Birmingham, United Kingdom
• Study site — Leeds, United Kingdom
• Study site — London, United Kingdom
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gainesville, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Fort Worth, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Morgantown, West Virginia, United States
• Study site — Westmead, New South Wales, Australia
• Study site — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.