Chronic Hepatitis C Treatment in Egyptian Children With Gaucher Disease.

• Status: Unknown status
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This prospective open label study is designed to screen all available Gaucher disease patients [either on enzyme replacement therapy (ERT) or not] for hepatitis C virus (HCV) infection. Furthermore to evaluate the safety and effectiveness of combined Sofosbuvir/Ledipasvir regimen given for 12 weeks in chronically infected patients aged 6-18 years.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University Children Hospital
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Sofosbuvir

Criteria

Inclusion Criteria:

• Aged 6 to <18 years

• Parent or legal guardian must provide written informed consent

• Treatment naïve or experienced children with chronic HCV infection

• 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)

Exclusion Criteria:

• Patients with other sever comorbidities of chronic medical illness (e.g. decompensated heart disease, chronic kidney insufficiency)

• Concomitant hepatitis B virus (HBV) or Human immunodeficiency virus (HIV) infection

• Medications (systemic steroids, immunosuppressives)

• Patients or guardians who are unwilling to participate or sign informed consent