Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naïve Children

• Status: Completed
• Trial end date: 2020-03-10
• Target enrollment: 0
• Participant gender: All

Summary

Chronic hepatitis C virus (HCV) infection represents a crucial health problem in children that greatly influence their quality of life. Many efforts have been directed toward the investment of effective drugs with high safety profiles and with oral administration for better compliance. The development of a new direct-acting antiviral (DAA) made it possible to achieve these goals.

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

Details

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

Criteria

• Inclusion Criteria:

• Chronic HCV infection (≥ 6 months).

• Weighing at least 35 kg.

• Treatment-naïve children with chronic HCV infection without cirrhosis or with compensated cirrhosis.

• Parent or legal guardian must provide written informed consent.

• Exclusion Criteria:

• Patients with comorbidity of chronic medical illness (decompensated heart disease, severe renal impairment (GFR < 30) or ESRD, uncontrolled DM).

• Concomitant HBV or HIV infection.

• Medications (Amiodarone, beta-blockers).