ClinicalTrials.Veeva

Menu

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

Bristol-Myers Squibb (BMS) logo

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)

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

Trial documents
2

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems