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.

Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Daclatasvir (DCV) in Combination with Sofosbuvir (SOF) in Children from 3 to less than 18 Years of Age with GT-1 to -6 Chronic Hepatitis C (CHC) Infection

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003338-94-DE

Enrollment

Registered

2018-02-22

Start date

2018-05-09

Completion date

Unknown

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C (CHC) Infection MedDRA version: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Daklinza 60 mg film-coated tablets Product Name: Daclatasvir 60mg Film Coated Tablet (Clinical Formulation) Product Code: BMS-790052-05 Pharmaceutical Form: Film-coated tablet INN or Propo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Participant/participant’s legal representative must provide written Informed Consent, and participants Assent when applicable 2) 3 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 - To determine the proportion of participants with SVR12 - To evaluate genotypic substitution(s) associated with virologic failure - 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)	—

Measure

Time frame

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 - To determine the proportion of participants with SVR12 - To evaluate genotypic substitution(s) associated with virologic failure - 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)

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Secondary

Measure	Time frame
Secondary end point(s): - Frequencies of serious adverse events (SAEs), adverse events (AEs) leading to discontinuation of study therapy, AEs by intensity, and laboratory abnormalities by toxicity grade on treatment and during follow-up - Proportion of participants with HCV RNA <LLOQ (TD or TND) at post-treatment follow-up Week 12 - Frequencies of NS5A and NS5B resistance-associated variants (RAVs) emergent at the time of virologic failure on treatment and during follow-up in nonresponders - 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	—

Measure

Time frame

Secondary end point(s): - Frequencies of serious adverse events (SAEs), adverse events (AEs) leading to discontinuation of study therapy, AEs by intensity, and laboratory abnormalities by toxicity grade on treatment and during follow-up - Proportion of participants with HCV RNA <LLOQ (TD or TND) at post-treatment follow-up Week 12 - Frequencies of NS5A and NS5B resistance-associated variants (RAVs) emergent at the time of virologic failure on treatment and during follow-up in nonresponders - 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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Countries

Australia, Germany, Poland, Romania, Spain, Taiwan

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026