Protocol Summary

Protocol No.: OCR16448

Sponsor Protocol No.: GS-US-342-1143;Gilead 342-1143

Protocol Title.: Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection

Principal Investigator: Jolley, Christopher

Objective: 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.

Phase: Phase II

Age Group: Children

Age: 3 Years - 17 Years

Gender: All

Scope: National

Treatment:

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

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.

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

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.

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.

Detailed Eligibility:

Key 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.

Applicable Conditions:

  • Hepatitis C
  • Participation Institution:

  • UF Gainesville : Patrick Horne
  • Contact:
    Patrick Horne
    Phone: +1 352-273-9464
    Email: patrick.horne@medicine.ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT03022981