Sofosbuvir/Ledipasvir for Hepatitis C Genotype 1-6 in Patients With Transfusion-Dependent Thalassemia: An Open Label Trial

• Status: Completed
• Trial end date: 2018-08-06
• Target enrollment: 0
• Participant gender: All

Summary

Sustained Viral Response following 12-week therapy (SVR 12) with sofosbuvir/ledipasvir in transfusion-dependent patients with HCV genotype 1-6

Secondary Objective(s):

Assessment of transfusion requirements Adverse events Efficacy in treatment-naïve vs. relapsers vs. null responders Efficacy in patients with advanced fibrosis/cirrhosis vs. F1, F2 by elastography

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

Details

• Lead Sponsor: Ala'a Sharara
• Collaborator: Gilead Sciences
• Treatments: Ledipasvir; Sofosbuvir; Velpatasvir

Criteria

Inclusion Criteria:

• Transfusion Dependent thalassemia patients with HCV genotype 1-6

• Age ≥18

• Male and female

• No evidence of hepatocellular carcinoma on ultrasound

• No known drug allergy to the FDA approved drug to be used

• Adequate iron chelation therapy

• Compensated liver disease

Exclusion Criteria:

• Age below 18

• Chronic HCV genotypes 2 or 3

• Allergy to study drug

• Hepatocellular carcinoma

• Inadequate iron chelation therapy

• Decompensated liver disease