Status:
TERMINATED
Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C
Chronic Hepatitis
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
June 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03487848
Start Date
June 25 2018
End Date
September 17 2020
Last Update
April 20 2021
Active Locations (2)
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1
Local Institution
Melbourne, Victoria, Australia, 3052
2
Local Institution
Barcelona, Spain, 08950