Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection

• Status: Terminated
• Trial end date: 2020-09-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Sofosbuvir

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Participants monoinfected with HCV genotype -1 to -6

• HCV RNA ≥1,000 IU/mL at Screening

• Participants who are HCV-treatment naïve or treatment experienced

• Participants in Cohort 1 must have a body weight ≥ 45kg at Day 1

Exclusion Criteria:

• Mixed genotype HCV infections

• Evidence of an ongoing medical condition contributing to chronic liver disease other than HCV

• Evidence of cirrhosis, either compensated or decompensated

• Prior exposure to sofosbuvir and/or NS5A inhibitor

Other protocol defined inclusion/exclusion criteria could apply