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

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ClinicalTrials.gov Identifier: NCT03032666
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Ala'a Sharara, American University of Beirut Medical Center

Brief 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


Condition or disease Intervention/treatment Phase
Thalassemia Hepatitis C Drug: sofosbuvir/velpatasvir Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sofosbuvir/Ledipasvir for Hepatitis C Genotype 1-6 in Patients With Transfusion-Dependent Thalassemia: An Open Label Trial
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : August 6, 2018
Actual Study Completion Date : August 6, 2018


Arm Intervention/treatment
Experimental: sofosbuvir/velpatasvir
Epclusa
Drug: sofosbuvir/velpatasvir
treatment of hepatitis C genotype 1-6 in patients with transfusion-dependent thalassemia.
Other Name: Epclusa




Primary Outcome Measures :
  1. Sustained Viral Response following 12-week therapy (SVR 12) with sofosbuvir/velpatasvir in transfusion-dependent patients with HCV genotype 1-6 [ Time Frame: 12 weeks ]
    Via tests of HepC RNA levels



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032666


Locations
Lebanon
American University of Beirut Medical Center
Beirut, Lebanon
Sponsors and Collaborators
Ala'a Sharara
Gilead Sciences

Responsible Party: Ala'a Sharara, Professor, Head of Gastroenterology Department, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT03032666     History of Changes
Other Study ID Numbers: IM.AS1.47
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Ala'a Sharara, American University of Beirut Medical Center:
Thalassemia
HCV
Sofosbuvir
Ledipasvir

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Thalassemia
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Sofosbuvir
Ledipasvir
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents