Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Collaborator: Cairo University
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Sofosbuvir

Criteria

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.