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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Chronic Hepatitis; Hepatitis C

Treatments: Drug: Sofosbuvir; Drug: Daclatasvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT03487848

2017-003338-94 (EudraCT Number)

AI444-423

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Daclatasvir with Sofosbuvir

Experimental group

Description:

Specified dose on specified days for specified duration

Treatment:

Drug: Daclatasvir

Drug: Sofosbuvir