NCT03487848

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

Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children From 3 to Less Than 18 Years of Age With GT-1 to -6 Chronic Hepatitis C (CHC) Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Hepatitis C
• Chronic Hepatitis

Interventions

Type	Name	Description
DRUG	Daclatasvir	Specified dose on specified days for specified duration
DRUG	Sofosbuvir	Specified dose on specified days for specified duration

Timeline

• Start date: 2018-06-25
• Primary completion: 2018-10-18
• Completion: 2020-09-17
• First posted: 2018-04-04
• Last updated: 2021-04-20
• Results posted: 2021-04-20

Locations

2 sites across 2 countries: Australia, Spain

Regulatory

• FDA-regulated drug study