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Trial record 57 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Hepatitis C Virus Infection in Patients With Hemoglobinopathies

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ClinicalTrials.gov Identifier: NCT03149289
Recruitment Status : Completed
First Posted : May 11, 2017
Last Update Posted : May 11, 2017
Sponsor:
Collaborators:
University of Cagliari
University of Turin, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Ente Ospedaliero Ospedali Galliera
University of Campania "Luigi Vanvitelli"
Cardarelli Hospital
Reggio Calabria
University of Palermo
Information provided by (Responsible Party):
Società Italiana Talassemie ed Emoglobinopatie

Brief 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.

Condition or disease Intervention/treatment
Hepatitis C, Chronic Hemoglobinopathies Drug: Antiviral drugs

Detailed Description:

Many patients with hemoglobinopathies have been infected with hepatitis C virus (HCV) through blood transfusion, mostly before screening of blood donors was introduced in 1992. The reported prevalence of anti-HCV-positive thalassemia patients varies between 4.4% in Turkey and 85.4% in Italy. HCV infection is associated with decompensated cirrhosis, hepatocellular carcinoma and other liver complications, especially if left untreated. Prevalence of cirrhosis in thalassemia patients up to 32% have been reported.

Thalassemia patients with cirrhosis have an increased risk of death. Progression of liver fibrosis is strongly related to the presence of chronic HCV infection and extent of iron overload. Thalassemia patients with elevated serum aminotransferase levels for >6 months should be tested for HCV infection and, in the event of HCV infection, HCV genotyping is recommended in order to plan antiviral therapy and the likelihood of response. Noninvasive transient elastography (FibroScan®) can be used to determine the presence of fibrosis in thalassemia patients with HCV infection.

Effective chelation therapy and treatment of HCV infection are needed in order to prevent liver complications and decrease morbidity and mortality. For many years, pegylated interferon (peg-IFN) plus ribavirin was the standard of care for the treatment of chronic HCV infection and decompensated cirrhosis. Studies of peg-IFN plus ribavirin have demonstrated sustained virological response (SVR) rates of 25−64% in patients with thalassemia and HCV infection. However, peg-IFN and ribavirin are both associated with anemia. Ribavirin-associated hemolysis leads to an increased requirement for blood transfusions, which in turn can lead to worsening of iron overload. Therefore, European Association for the Study of the Liver (EASL) 2015 guidelines recommend interferon-free regimens for the treatment of HCV infection in patients with hemoglobinopathies. The aim of this study was to evaluate the safety and efficacy of DAA standard regimens in patients with hemoglobinopathies and chronic HCV liver disease treated in Italy.

Antiviral treatments were administered according to Italian Medicines Agency (AIFA) guidelines.


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Study Type : Observational
Actual Enrollment : 168 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment of Hepatitis C Virus Infection With Direct-acting Antiviral Drugs in Patients With Hemoglobinopathies
Study Start Date : March 1, 2015
Actual Primary Completion Date : March 1, 2016
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
HCV RNA positive
hemoglobinopathies with hepatites C treated with antiviral drugs
Drug: Antiviral drugs
sofosbuvir, ribavirin, daclatasvir, ledipasvir, simeprevir, paritaprevir, dasabuvir, ombitasvir
Other Name: Direct-acting antiviral drugs'




Primary Outcome Measures :
  1. Change in the number of participants with undetectable serum HCV RNA is being assessed at the end of treatment [ Time Frame: baseline and 12 weeks ]
    The quantification of hepatitis virus particles in serum is assessed and expressed in IU/mL (IU, international units ) through quantitation of virus ribonucleic acid by real time polymerase chain reaction (PCR).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with hemoglobinopathies with cronic hepatitis C
Criteria

Inclusion Criteria:

  • Patients with hemoglobinopathies, chronic hepatitis due to HCV and the presence of fibrosis (defined as Fibroscan® stiffness ≥10 kPa) or a bioptic evaluation of cirrhosis (same ISHAK fibrosis score) determined within 6 months previously. Patients with extrahepatic manifestations of chronic hepatitis C virus infection (cryoglobulinemia with organ damage, B-lymphoproliferative disorders) were also included.

Exclusion Criteria:

  • Patients with active cancer, including hepatocellular carcinoma, and pregnant or lactating females were excluded from the study

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): NCT03149289


Sponsors and Collaborators
Società Italiana Talassemie ed Emoglobinopatie
University of Cagliari
University of Turin, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Ente Ospedaliero Ospedali Galliera
University of Campania "Luigi Vanvitelli"
Cardarelli Hospital
Reggio Calabria
University of Palermo
Investigators
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Study Director: Vito Di Marco, MD University of Palermo, Palermo, Italy

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Responsible Party: Società Italiana Talassemie ed Emoglobinopatie
ClinicalTrials.gov Identifier: NCT03149289     History of Changes
Other Study ID Numbers: HCV-SITE
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hemoglobinopathies
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Hepatitis, Chronic
Hematologic Diseases
Genetic Diseases, Inborn
Antiviral Agents
Anti-Infective Agents