NCT00887081

Brief Summary

Worldwide, several studies report that 4.4% to 85.4% of thalassemia patients were positive for anti hepatitis C antibodies. Recently, three different studies reported the efficacy and the safety of combination therapy with pegylated interferon and ribavirin in thalassemic patients. This study is carried ahead to assess the impact of combination therapy with pegylated-interferon and ribavirin in a large cohort of italian patients with beta thalassemia major - transfused and not transfused, sickle cell disease and sickle/beta-thalassemia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 23, 2009

Status Verified

April 1, 2009

Enrollment Period

4.9 years

First QC Date

April 21, 2009

Last Update Submit

April 22, 2009

Conditions

Hemoglobinopathies

Keywords

antiviral treatment in hemoglobinopathiesmanagement of chronic viral hepatitis C infectionantiviral treatment

Outcome Measures

Primary Outcomes (1)

  • A sustained virological response (SVR), defined as absence of HCV RNA in serum by a highly sensitive test at the end of treatment and 6 months late.

    from 6 to 12 months

Secondary Outcomes (1)

  • Early virological response (EVR) , defined as the loss of HCV RNA during the first 12 weeks of therapy; main side effects enclosing changes in blood transfusion requirement; increase in ferritin levels and variations in chelation treatment

    from 6 to 12 months

Study Arms (1)

Interferon and Ribavirin

EXPERIMENTAL

Patients with hemoglobinopathy will receive Interferon and Ribavirin

Drug: PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin

Interventions

PEG-IFN alpha2a or PEG-IFN alpha2b and RibavirinDRUG

PEG-IFN alpha2a 180 mcg weekly or PEG-IFN alpha2b 1.5 mcg/kg of body weight weekly plus ribavirin 800-1200 mg daily according to body weight.

Also known as: Pegasis, Rebetol
Interferon and Ribavirin

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Thalassemia Major or Sickle Cell Disease or Sickle/Beta Thalassemia patients
  • Regularly transfused (hemoglobin ≥ 9.5 gr/dl) or not transfused, under or not iron chelation regimen
  • With positivity to HCV-RNA and chronic liver disease with or without cirrhosis, naïve or non-responder or relapser after interferon mono-therapy

You may not qualify if:

  • Thalassemia Major or Sickle Cell Disease or Sickle/Beta Thalassemia patients with not compensated liver failure or heart failure
  • Low white blood cells (neutrophils \< 1.500/mmc and/or white blood cells \< 3.000/mmc)
  • Low platelets count (\< 100.000/mmc)
  • Significant positivity to Coombs test with clinical and serologic evidence of immune hemolytic anemia, severe endocrinopathy, detection of high titre autoantibodies, co-infection with HBV (HbsAg positive)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOVCervello

Palermo, 90100, Italy

RECRUITING

MeSH Terms

Conditions

Hemoglobinopathies

Interventions

peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Aurelio Maggio, M.D.

    Azienda Ospedaliera V. Cervello

    STUDY CHAIR

  • Gaetano Restivo, M.D.

    Azienda Ospedaliera V. Cervello

    PRINCIPAL INVESTIGATOR

  • Disma Renda, M.D.

    Azienda Ospedaliera V. Cervello

    STUDY DIRECTOR

Central Study Contacts

Aurelio Maggio, M.D.

CONTACT

00390916885251aureliomaggio@virgilio.it

Gaetano Restivo, M.D.

CONTACT

00390916802976101dalmatians@tele2.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 23, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 23, 2009

Record last verified: 2009-04

Locations

IT(1)