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-DE

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 5

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the PK profile of DCV in combination with SOF in children and adolescents aged 3 to <18 years of age;Secondary Objective: - To assess the safety and tolerability of the DCV+SOF regimen in pediatric participants<br>- To determine the proportion of participants with SVR12<br>- To evaluate genotypic substitution(s) associated with virologic failure<br>- To assess the acceptability and palatability for the age-appropriate chewable tablet formulation, and acceptability for adult film-coated tablet;Primary end point(s): Pharmacokinetic parameters (Cmin, Cmax, Tmax, AUC (TAU), CLT/F) for DCV derived from plasma concentration versus time data on Day 10 (± 3 days) ;Timepoint(s) of evaluation of this end point: Day 10 (± 3 days)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Frequencies of serious adverse events (SAEs), adverse events (AEs) leading to discontinuation of<br>study therapy, AEs by intensity, and laboratory abnormalities by toxicity grade on treatment and<br>during follow-up<br>- Proportion of participants with HCV RNA <LLOQ (TD or TND) at post-treatment follow-up Week 12<br>- Frequencies of NS5A and NS5B resistance-associated variants (RAVs) emergent at the time of virologic failure on treatment and during follow-up in nonresponders<br>- Summary of responses from questionnaire assessing acceptability and palatability at Day 1, Week 4, and Week 12;Timepoint(s) of evaluation of this end point: Timepoints are outlined above for each endpoint

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