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

Primary Purpose

Hepatitis C Virus Infection

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

LDV/SOF

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection focused on measuring HCV genotype 1 or 4 (GT-1 or GT-4), Direct Acting Antiviral, Combination Therapy, Hepatitis C, Chronic, Liver Diseases, Virus Diseases

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Cancer Institute, Cairo University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LDV/SOF

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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.

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.

Percentage of Participants With HCV RNA < LLOQ While on Treatment

HCV RNA Change From Baseline/Day 1

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

Full Information

NCT ID

NCT02868242

First Posted

August 11, 2016

Last Updated

February 18, 2020

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02868242

Brief Title

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

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

August 28, 2016 (Actual)

Primary Completion Date

November 12, 2018 (Actual)

Study Completion Date

February 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LDV/SOF

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

LDV/SOF

Other Intervention Name(s)

Harvoni®, GS-5885/GS-7977

Intervention Description

Tablet(s) administered orally once daily

Primary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

Description

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 50 IU/mL) at 12 weeks after stopping study treatment.

Time Frame

Posttreatment Week 12

Title

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

Time Frame

First dose date up to Week 12

Secondary Outcome Measure Information:

Title

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

Description

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.

Time Frame

Posttreatment Week 4

Title

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

Description

SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.

Time Frame

Posttreatment Week 24

Title

Percentage of Participants With HCV RNA < LLOQ While on Treatment

Time Frame

Weeks 1, 4, 8, and 12

Title

HCV RNA Change From Baseline/Day 1

Time Frame

Baseline; Weeks 1, 4, 8, and 12

Title

Percentage of Participants With Virologic Failure

Description

Time Frame

Baseline to Posttreatment Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilead Study Director

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

Facility Name

National Cancer Institute, Cairo University

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing URL

https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

Citations:

PubMed Identifier

35149641

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.

Results Reference

derived

Learn more about this trial

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

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