Clinical trial NCT02868242: Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy
Official title: A Phase 2, Open-label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Subjects Undergoing Cancer Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus Infection
Keywords: HCV genotype 1 or 4 (GT-1 or GT-4)
Direct Acting Antiviral
Combination Therapy
Hepatitis C, Chronic
Liver Diseases
Virus Diseases
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2016-08-16
Enrollment: 19
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
timeFrame: First dose date up to Week 12
Secondary outcomes:
measure: Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)
timeFrame: Posttreatment Week 4
measure: Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)
timeFrame: Posttreatment Week 24
measure: Percentage of Participants With HCV RNA < LLOQ While on Treatment
timeFrame: Weeks 1, 4, 8, and 12
measure: HCV RNA Change From Baseline/Day 1
timeFrame: Baseline; Weeks 1, 4, 8, and 12
measure: Percentage of Participants With Virologic Failure
timeFrame: Baseline to Posttreatment Week 24
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute, Cairo University
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: El-Sayed MH, Ebeid FSE, Zekri AR, Massetto B, Kersey K, Zhang F, Gaggar A, Elsayed W, El-Haddad A. Ledipasvir-sofosbuvir in Adolescents With Chronic Hepatitis C and Hematological Malignancies Undergoing Chemotherapy. J Pediatr Gastroenterol Nutr. 2022 May 1;74(5):626-630. doi: 10.1097/MPG.0000000000003406. Epub 2022 Feb 10.