TerminatedPhase 2

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

Stopped: Business objectives have changed

Australia, Spain5 participantsStarted 2018-06-25

Plain-language summary

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

Who can participate

Age range12 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir

Timeframe: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose

Maximum Observed Plasma Concentration (Cmax) for Daclatasvir

Timeframe: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose

Time of Maximum Observed Plasma Concentration (Tmax) for Daclatasvir

Timeframe: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose

Area Under the Concentration-Time Curve (AUC(TAU)) for Daclatasvir

Timeframe: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose

Apparent Total Body Clearance (CLT/F) for Daclatasvir

Timeframe: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose

Trial details

NCT IDNCT03487848

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10-18

Results submitted2021-03-12

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