Hepatitis C Virus Infection in Patients With Hemoglobinopathies

NCT03149289 | Completed FDA Drug

• 1 other identifier: HCV-SITE
• Study Type: observational
• Target: 168
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C, Chronic; Hemoglobinopathies

Outcome Measures

Primary Outcomes (1)

• Change in the number of participants with undetectable serum HCV RNA is being assessed at the end of treatment

  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).

  baseline and 12 weeks

Study Arms (1)

HCV RNA positive

hemoglobinopathies with hepatites C treated with antiviral drugs

Drug: Antiviral drugs

Interventions

Antiviral drugs DRUG

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

Also known as: Direct-acting antiviral drugs'

HCV RNA positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with hemoglobinopathies with cronic hepatitis C

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Società Italiana Talassemie ed Emoglobinopatie: lead
• University of Cagliari: collaborator
• University of Turin, Italy: collaborator
• Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• Ente Ospedaliero Ospedali Galliera: collaborator
• University of Campania Luigi Vanvitelli: collaborator
• Cardarelli Hospital: collaborator
• Reggio Calabria: collaborator
• University of Palermo: collaborator

MeSH Terms

Conditions

Hepatitis C, Chronic; Hemoglobinopathies

Interventions

Antiviral Agents

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Vito Di Marco, MD

  University of Palermo, Palermo, Italy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: May 11, 2017
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: February 1, 2017
• Last Updated: May 11, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share