PK of SOF/LED in HCV - Infected Adolescents With Haematological Disorders

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, controlled, open-label, pharmacokinetic study. This study aims at studying the PK of sofosbuvir, ledipasvir and sofosbuvir metabolite (GS-331007) in HCV infected children with hematological Disorders. to develop predictive pharmacokinetic model for the 3 moieties in the studied population.

In this study, patients in both treatment groups will receive 12 weeks of treatment with a fixed-dose combination tablet containing 400 mg of sofosbuvir and 90 mg of ledipasvir(SOF/LED) orally, once daily with food.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

Inclusion criteria:

• Adolescents (ages 12-18 years) and/ or weight more than 35 Kg

• Diagnosed with beta-thalassemia major and receiving regular blood transfusion

• spleenectomised

• Chronic HCV infection (defined as more than 6 months history of the disease)

• Naïve non-cirrhotic population with FIB Score: F0 to F3 as measured by Fibroscan

• Screening laboratory values of the beta-thalassemia group within the following thresholds (absolute neutrophil count > 1500/mm3, platelets > 7500 cells/mm3 , Serum creatinine < 1.2 mg/dl, creatinine clearance > 40 mL/min, albumin >3.5 gm/dl, and aspartate transaminase (AST) and alanine transaminase (ALT) level less than 5 fold of the normal limit). Control group should have normal biochemical profile.

• Assent of the patients and consent of their legal guardians are required

Exclusion Criteria:

• Previous treatment for HCV.

• History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol or affect the pharmacokinetics of the study drugs. Such as,

• Ongoing or untreated cancer including haematologic and hepatic cancers

• Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus or hepatitis B virus

• Clincal hepatic decompensation (i.e., ascites, encephalopathy or variceal haemorrhage)

• Renal dysfunction

• Active infection (any infection showing clinical manifestation at time of sampling)

• Known hypersensitivity to study medications

• Ongoing treatment with cyclosporine, rifampin, phenytoin, carbamazepine, phenobarbital, or amiodarone.