Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With Chronic Hepatitis C Virus (HCV) Infection

• Status: Terminated
• Trial end date: 2020-02-19
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the steady-state pharmacokinetics (PK) and confirm the age-appropriate dose of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Sofosbuvir; Sofosbuvir-velpatasvir drug combination

Criteria

Key Inclusion Criteria:

• Consent of parent or legal guardian required

• Chronic HCV infection

• Screening laboratory values within defined thresholds

• Individuals must have a determination of prior treatment status:

• DAA-naive is defined as either:

• Treatment naive with no prior exposure to any interferon (IFN), ribavirin (RBV), or approved or experimental HCV-specific DAA

• Treatment experienced with an IFN-based regimen and no prior exposure to an approved or experimental HCV-specific DAA

• DAA-experienced is defined as prior exposure to a regimen including any DAA (eg, non-structural protein (NS)3/4A protease inhibitor, NS5A inhibitor, or NS5B nucleotide/nucleoside inhibitor)

Key Exclusion Criteria:

• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

• Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV) or hepatitis B virus (HBV)

• Clinical hepatic decompensation (eg, clinical ascites, encephalopathy, and/or variceal hemorrhage)

• Pregnant or nursing females

• Known hypersensitivity to study medication

• Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

Note: Other protocol defined Inclusion/Exclusion criteria may apply.