Clinical trial · Interventional
Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy
NCT03903185CI-TRIAL-00069000completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, controlled, open-label, pharmacokinetic study. This study aims at studying the PK of ledipasvir, sofosbuvir, and GS-331007 metabolite in HCV infected children with hematological malignancy. In this study, patients in both treatment groups will receive 12 weeks of treatment with a fixed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir (LDV/SOF) orally, once daily with food.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hepatitis C, Chronic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ledipasvir / Sofosbuvir Oral Product | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- HCV-infected patients with hematological malignancy
- description
- HCV-infected patients with hematological malignancy on maintenance chemotherapy
- interventionNames
- Drug: Ledipasvir / Sofosbuvir Oral Product
- type
- ACTIVE_COMPARATOR
- label
- Control HCV-infected patients
- description
- Control HCV-infected patients without haematological malignancy or co-morbidities.
- interventionNames
- Drug: Ledipasvir / Sofosbuvir Oral Product
Primary outcomes (1)
- measure
- Measurement of the pharmacokinetics of LDV\SOF
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Children (6 to \< 12 years of age and/or weighing 17.5 to \< 35 Kg). * Chronic HCV genotype 4 infection for at least 6 months without cirrhosis (confirmed by Fibroscan). * Naïve patients to previous anti-HCV treatment. * Diagnosed with hematological malignancy and on maintenance chemotherapy. Exclusion Criteria: * Known hypersensitivity to any of the study medications. * Ongoing treatment with any interacting medications like carbamazepine, fosphenytoin, phenytoin, oxcarbazepine, phenobarbital, and rifampin. * History of any comorbid illness that may interfere with the pharmacokinetics of the study drugs or prohibit the compliance with the study protocol such as; 1. Decompensated liver disease as shown by the presence of ascites, encephalopathy, or a history of variceal hemorrhage. 2. The ongoing treatment of other types of cancer or blood disorders. 3. Co-infection with human immunodeficiency virus (HIV), or hepatitis B virus. 4. Renal dysfunction. 5. Active infection that is currently producing symptoms.
References
Publications (2)
- DERIVEDAbdelMagid AM, Abbassi MM, Ebeid FS, El-Sayed MH, Farid SF. Population Pharmacokinetics of Ledipasvir/Sofosbuvir in Pediatric Patients: Impact of Acute Lymphoblastic Leukemia. Clin Ther. 2025 Feb;47(2):e5-e15. doi: 10.1016/j.clinthera.2024.11.022. Epub 2024 Dec 19. PMID 39706761
- DERIVEDAbdelMagid AM, Abbassi MM, Ebeid FS, Farid SF, El-Sayed MH. Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancies: A Pharmacokinetic Study. Clin Ther. 2024 Jan;46(1):e12-e22. doi: 10.1016/j.clinthera.2023.10.007. Epub 2023 Nov 3. PMID 37925363