A study to determine how effect and safe Daclatasvir plus Sofosbuvir treatment is for children aged between 3-18 years of age with Hepatitis C.

Phase 1

• Conditions: Chronic Hepatitis C (CHC) Infection; MedDRA version: 20.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-003338-94-PL
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-15
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) Participant/participant’s legal representative must provide written Informed Consent, and participants Assent when applicable
2) 3 to < 18 years of age on Day 1 of study treatment
3) = 10 kg at Day 1
4) Chronic HCV infection GT-1 to -6 with HCV RNA = 1,000 IU/mL at Screening
5) Non-cirrhotic
6) HCV-treatment naive or treatment experienced, with the exception of previous exposure to SOF and/or any NS5A inhibitors

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a) Mixed genotype HCV infections
b) Evidence of an ongoing medical condition contributing to chronic liver disease other than HCV
c) Evidence of cirrhosis, either compensated or decompensated
d) Positive serological test for chronic HBV-infection (HBsAg+) and/or HIV-infection
e) Inability to tolerate oral medication

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified