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

September 16, 2009 updated by: Baqiyatallah Medical Sciences University

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

Hemophilic patients are a known high risk groups for acquiring the hepatitis C. The surveillance data from Ministry Of Health in IR.Iran had shown that 60% of them are infected with HCV infection. We are trying the PEGASYS plus Ribavirin in Hemophilic patients with HCV.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators enroll 400 patients into the study. The patients receive PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 800 microgram for Genotype 2 and 3 and 1000 milligram for weight less than 75 kg and 1200 milligram for more than 75 kg. The duration of protocol is depends on genotypes of virus. In genotype 1 and 4, for 48 week and in genotypes 2 and 3 , for 24 weeks. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA 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. We have omitted the liver biopsy in the patients.

Study Type

Interventional

Enrollment (Anticipated)

400

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 (Child, Adult, Older Adult)

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
  • Hx of 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 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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Genotype 2 or 3 in Hemophilic 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
Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: 800 milligram per day (PO)
Other Names:
  • Peginterferon Alfa-2a (40KD) Plus COPEGUS
Active Comparator: 2
Other Genotypes (except 2 or 3) in Hemophilic 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
Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: 800 milligram 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
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
End of Treatment Response
Time Frame: 24 weeks for : Genotype 2 & 3; 48 Weeks for other genotype
24 weeks for : Genotype 2 & 3; 48 Weeks for other genotype

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

Shahid Beheshti University of Medical Sciences
Guilan University of Medical Sciences
Iran 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: Professor Seyed-Moayed Alavian, Professor, Baqiyatallah Research Center for Gastroenterology and Liver Diseases
  • Study Director: Seyyed Mohammad Miri, M.D., Baqiyatallah Research Center for Gastroenterology and Liver Diseases
  • Principal Investigator: Bashir HajiBeigi, M.D., Iranian Blood Transfusion Research Center

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

March 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 27, 2008

First Posted (Estimate)

July 1, 2008

Study Record Updates

Last Update Posted (Estimate)

September 17, 2009

Last Update Submitted That Met QC Criteria

September 16, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRCGL-07-03

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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