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Hepatitis C Virus Infection in Patients With Hemoglobinopathies

NCT03149289 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 168

Last updated 2017-05-11

No results posted yet for this study

Summary

Progression of liver fibrosis in patients with hemoglobinopathies is strongly related to the severity of iron overload and the presence of chronic hepatitis C virus (HCV) infection. Effective iron chelation therapy and HCV infection eradication are efficacy to prevent liver complications. EASL and AASLD guidelines recommend interferon-free regimens for the treatment of HCV infection in patients with hemoglobinopathies. However, data regarding the use of direct-acting antiviral drugs (DAAs) in this patient population are very few This large, observational study evaluated the safety and efficacy of standard therapy with DAAs in a large Italian cohort of with hemoglobinopathies, chronic HCV infection and advanced liver fibrosis.

Conditions

  • Hepatitis C, Chronic
  • Hemoglobinopathies

Interventions

DRUG

Antiviral drugs

sofosbuvir, ribavirin, daclatasvir, ledipasvir, simeprevir, paritaprevir, dasabuvir, ombitasvir

Sponsors & Collaborators

  • University of Cagliari

    collaborator OTHER

  • University of Turin, Italy

    collaborator OTHER

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

    collaborator OTHER

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    collaborator OTHER

  • Ente Ospedaliero Ospedali Galliera

    collaborator OTHER

  • University of Campania Luigi Vanvitelli

    collaborator OTHER

  • Cardarelli Hospital

    collaborator OTHER

  • Reggio Calabria

    collaborator OTHER

  • University of Palermo

    collaborator OTHER

  • Società Italiana Talassemie ed Emoglobinopatie

    lead OTHER

Principal Investigators

  • Vito Di Marco, MD · University of Palermo, Palermo, Italy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-01
Primary Completion
2016-03-01
Completion
2017-02-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03149289 on ClinicalTrials.gov