Sofosbuvir/Ledipasvir for Hepatitis C Genotype 1-6 in Patients With Transfusion-Dependent Thalassemia: An Open Label Trial
NCT03032666 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2018-10-11
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
Conditions
- Thalassemia
- Hepatitis C
Interventions
- DRUG
-
sofosbuvir/velpatasvir
treatment of hepatitis C genotype 1-6 in patients with transfusion-dependent thalassemia.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Ala'a Sharara
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-01
- Primary Completion
- 2018-08-06
- Completion
- 2018-08-06
- FDA Drug
- Yes
Countries
- Lebanon
Study Locations
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