Overview

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