Phase 2
Completed N=19
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy
Source: ClinicalTrials.gov NCT02868242 ↗Enrolled (actual)
19
Serious AEs
15.8%
Results posted
Aug 2019
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 100.0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
100.0 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event |
— | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4) |
100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24) |
100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ While on Treatment |
89.5; 100.0; 94.7; 100.0 | — |
| SECONDARY HCV RNA Change From Baseline/Day 1 |
-3.34; -3.62; -3.36; -3.62 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
— | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02868242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.