Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy

• Status: Completed
• Trial end date: 2019-02-03
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric participants who are undergoing cancer chemotherapy.

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

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Sofosbuvir

Criteria

Key Inclusion Criteria:

• Aged 12 to <18 years

• Parent or legal guardian must provide written informed consent

• Treatment naïve or experienced children with genotype 1 or 4 HCV infection, and are on a maintenance cancer chemotherapy regimen

• Receiving a protocol-approved maintenance chemotherapy regimen for a hematological malignancy

• Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy

• Screening laboratory values within defined thresholds

• No History of solid organ or bone marrow transplantation

• No history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)

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