Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy
NCT ID: NCT02868242
Last Updated: 2020-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
19 participants
INTERVENTIONAL
2016-08-28
2019-02-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LDV/SOF
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.
LDV/SOF
Tablet(s) administered orally once daily
Interventions
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LDV/SOF
Tablet(s) administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
12 Years
17 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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National Cancer Institute, Cairo University
Cairo, , Egypt
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GS-US-337-1904
Identifier Type: -
Identifier Source: org_study_id
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