Pegasys® Plus Ribavirin in Thalassemic Patients With Hepatitis C Virus Infection

August 30, 2010 updated by: Baqiyatallah Medical Sciences University

A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Thalassemic Patients With Chronic Hepatitis C Infection

Antiviral treatment of HCV in thalassemia has raised concerns of ribavirin-induced hemolysis and increased iron loading. Blood Transfusion in Thalassemic patients are a known high risk for acquiring hepatitis C. The investigators are trying the PEGASYS (Peginterferon alpha-2a(40 KD)) plus Ribavirin in Thalassemic patients with HCV.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with Thalassemia receive chronic blood transfusions and have an increased prevalence of chronic Hepatitis C virus (HCV) infection, particularly if transfused before HCV serological testing became available. The investigators enrolled 300 patients into the study. The patients received PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 1000 milligram for weight less than or equal 75 kg and 1200 milligram for more than 75 kg for 48 weeks. Follow up period is 6 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the third months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 14155-3651
        • Baqiyatallah Research Center for Gastroenterology and Liver Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HCV RNA positive
  • Age older than 12 years

Exclusion Criteria:

  • Ongoing pregnancy or breast feeding
  • History (Hx) of Hepatocellular Carcinoma (HCC)
  • Hx of alcoholic liver disease
  • Hx of bleeding from esophageal varices
  • Hx of hemochromatosis
  • Hx of autoimmune hepatitis
  • Hx of Suicidal attempt
  • Hx of cerebrovascular dis
  • Hx of severe retinopathy
  • Hx of severe psoriasis
  • Hx of scleroderma
  • Hx of metabolic liver disease
  • Hx of Systemic Lupus Erythematosus (SLE)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Thalassemic Patients with HCV
Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: [=<75 kg: 1000 mg; >75 kg: 1200 mg per day (PO)]
Other Names:
  • Peginterferon Alfa-2a (40KD) plus COPEGUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Early Virologic Response
Time Frame: After 12 weeks of Treatment
After 12 weeks of Treatment
End of Treatment Response
Time Frame: 48 Weeks
48 Weeks
Sustained Virologic Response
Time Frame: 24 weeks after Treatment
24 weeks after Treatment
Rapid Virologic Response
Time Frame: One month after Treatment
One month after Treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerability of drugs for whole therapy period
Time Frame: During Treatment
During Treatment
Biochemical response (ALT)
Time Frame: End of Treatment AND 24 weeks after Treatment
End of Treatment AND 24 weeks after Treatment
Laboratory Parameters
Time Frame: During Treatment AND End of treatment
During Treatment AND End of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baqiyatallah Medical Sciences University

Collaborators

Guilan University of Medical Sciences
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Tehran Hepatitis Center
Tabriz Research Center for Gastroenterology and Liver Diseases

Investigators

  • Study Chair: Seyed-Moayed Alavian, Professor, Baqiyatallah Research Center for Gastroenterology and Liver Disea
  • Study Director: Seyyed Mohammad Miri, M.D., Baqiyatallah Research Center for Gastroenterology and Liver Disea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

June 26, 2008

First Submitted That Met QC Criteria

June 30, 2008

First Posted (ESTIMATE)

July 1, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 31, 2010

Last Update Submitted That Met QC Criteria

August 30, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRCGL-08-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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