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

Hepatitis C Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868242
• Other study ID #: GS-US-337-1904
• Status: Completed
• Phase: Phase 2
• Start date: August 28, 2016
• Est. completion date: February 3, 2019

Study information

• Verified date: July 2019
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 3, 2019
• Est. primary completion date: November 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection
• Infection
• Virus Diseases

Intervention

Drug:
• LDV/SOF
Tablet(s) administered orally once daily

Locations

Country	Name	City	State
Egypt	National Cancer Institute, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 50 IU/mL) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Primary	Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event		First dose date up to Week 12
Secondary	Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)	SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.	Posttreatment Week 4
Secondary	Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)	SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.	Posttreatment Week 24
Secondary	Percentage of Participants With HCV RNA < LLOQ While on Treatment		Weeks 1, 4, 8, and 12
Secondary	HCV RNA Change From Baseline/Day 1		Baseline; Weeks 1, 4, 8, and 12
Secondary	Percentage of Participants With Virologic Failure	Virologic failure was defined as: On-treatment virologic failure: Breakthrough (confirmed HCV RNA = LLOQ after having previously had HCV RNA < LLOQ while on treatment), or; Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or; Non-response (HCV RNA persistently = LLOQ through 8 weeks of treatment); Virologic relapse: Confirmed HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit	Baseline to Posttreatment Week 24