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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02868242 |
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Date of registration:
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11/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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August 28, 2016 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02868242 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Gilead Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gilead Sciences |
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Key inclusion & exclusion criteria
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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.
Age minimum:
12 Years
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hepatitis C Virus Infection
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Intervention(s)
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Drug: LDV/SOF
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Primary Outcome(s)
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Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
[Time Frame: First dose date up to Week 12]
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
[Time Frame: Posttreatment Week 12]
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Secondary Outcome(s)
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HCV RNA Change From Baseline/Day 1
[Time Frame: Baseline; Weeks 1, 4, 8, and 12]
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Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)
[Time Frame: Posttreatment Week 4]
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Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)
[Time Frame: Posttreatment Week 24]
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Percentage of Participants With HCV RNA < LLOQ While on Treatment
[Time Frame: Weeks 1, 4, 8, and 12]
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Percentage of Participants With Virologic Failure
[Time Frame: Baseline to Posttreatment Week 24]
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Secondary ID(s)
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GS-US-337-1904
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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