Purpose

This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase. The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection. The primary objective of the Treatment Phase is to evaluate the safety and tolerability of SOF/VEL for 12 weeks in pediatric participants with chronic HCV.

Condition

Eligibility

Eligible Ages
Between 3 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Chronic HCV-infected, treatment-naive and treatment-experienced adolescent and pediatric individuals aged 3 to < 18 as determined at Day 1.

Note: Other protocol defined Inclusion/

Exclusion Criteria

may apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PK Lead-in Phase: Cohort 1 (12 to < 18 years old)
SOF/VEL FDC (1 x 400/100 mg tablet or 2 x 200/50 mg tablets) for 7 days
  • Drug: SOF/VEL
    FDC tablet or oral granules administered once daily
    Other names:
    • Epclusa®
    • GS-7977/GS-5816
Experimental
PK Lead-in Phase: Cohort 2 (6 to < 12 years old)
Pending PK and safety results from Cohort 1, participants in Cohort 2 will initiate and receive SOF/VEL FDC (age-appropriate dose) for 7 days.
  • Drug: SOF/VEL
    FDC tablet or oral granules administered once daily
    Other names:
    • Epclusa®
    • GS-7977/GS-5816
Experimental
PK Lead-in Phase: Cohort 3 (3 to < 6 years old)
3 to < 6 years of age: SOF/VEL FDC 200/50 mg oral granules (4 x 50/12.5 mg packets) administered once daily, for participants who weigh ≥17 kg; SOF/VEL FDC 150/37.5 mg oral granules (3 x 50/12.5 mg packets) administered once daily, for participants who weigh < 17 kg
  • Drug: SOF/VEL
    FDC tablet or oral granules administered once daily
    Other names:
    • Epclusa®
    • GS-7977/GS-5816
Experimental
Treatment Phase: Group 1 (12 to < 18 years old)
Participants from the PK Lead-in will immediately rollover into Treatment Phase with no interruption of study drug administration until the appropriateness of the dose has been confirmed by PK and safety results from the PK Lead-in. Additional participants (12 to < 18 years of age) will be enrolled in the Treatment Phase upon confirmation of the appropriateness of the dose from the PK Lead-in Phase and will receive SOF/VEL FDC for 12 weeks.
  • Drug: SOF/VEL
    FDC tablet or oral granules administered once daily
    Other names:
    • Epclusa®
    • GS-7977/GS-5816
Experimental
Treatment Phase: Group 2 (3 to < 12 years old)
Participants from the PK Lead-in will immediately rollover into Treatment Phase with no interruption of study drug administration until the appropriateness of the dose has been confirmed by PK and safety results from the PK Lead-in. Additional participants (3 to < 12 years of age) will be enrolled in the Treatment Phase upon confirmation of the appropriateness of the dose from the PK Lead-in Phase and will receive SOF/VEL FDC for 12 weeks.
  • Drug: SOF/VEL
    FDC tablet or oral granules administered once daily
    Other names:
    • Epclusa®
    • GS-7977/GS-5816

More Details

NCT ID
NCT03022981
Status
Active, not recruiting
Sponsor
Gilead Sciences

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.