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

NCT02868242 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GS-US-337-1904
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

  First dose date up to Week 12

Secondary Outcomes (5)

• Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)

  Posttreatment Week 4

• Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)

  Posttreatment Week 24

• Percentage of Participants With HCV RNA < LLOQ While on Treatment

  Weeks 1, 4, 8, and 12

• HCV RNA Change From Baseline/Day 1

  Baseline; Weeks 1, 4, 8, and 12

• Percentage of Participants With Virologic Failure

  Baseline to Posttreatment Week 24

Study Arms (1)

LDV/SOF

EXPERIMENTAL

Participants will receive LDV/SOF 90/400 mg fixed dose combination (FDC) (1x 90/400 mg tablet or 4 x 22.5/100 mg tablets based on swallowability assessment during screening) for 12 weeks.

Drug: LDV/SOF

Interventions

LDV/SOF DRUG

Tablet(s) administered orally once daily

Also known as: Harvoni®, GS-5885/GS-7977

LDV/SOF

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

National Cancer Institute, Cairo University

Cairo, Egypt

Location

Related Publications (1)

• 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.

  PMID: 35149641 DERIVED

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic; Liver Diseases; Virus Diseases

Interventions

ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 16, 2016
• Study Start: August 28, 2016
• Primary Completion: November 12, 2018
• Study Completion: February 3, 2019
• Last Updated: March 2, 2020
• Results First Posted: August 20, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

EG (1)