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

This study is currently recruiting participants.
Verified by Baqiyatallah Medical Sciences University, June 2008

Sponsors and Collaborators: Baqiyatallah Medical Sciences University
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Tehran Hepatitis Center
Guilan Research Center for Gastroenterology and Liver Diseases
Tabriz Research Center for Gastroenterology and Liver Diseases
Information provided by: Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier: NCT00707850
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Thalassemia
Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
Phase IV

Genetics Home Reference related topics:   beta thalassemia   

MedlinePlus related topics:   Hepatitis    Hepatitis C    Liver Diseases    Thalassemia   

Drug Information available for:   Ribavirin    Peginterferon Alfa-2a   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Thalassemic Patients With Chronic Hepatitis C Infection

Further study details as provided by Baqiyatallah Medical Sciences University:

Primary Outcome Measures:
  • Early Virologic Response [ Time Frame: After 12 weeks of Treatment ] [ Designated as safety issue: No ]
  • End of Treatment Response [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • Sustained Virologic Response [ Time Frame: 24 weeks after Treatment ] [ Designated as safety issue: No ]
  • Rapid Virologic Response [ Time Frame: One month after Treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability of drugs for whole therapy period [ Time Frame: During Treatment ] [ Designated as safety issue: Yes ]
  • Biochemical response (ALT) [ Time Frame: End of Treatment AND 24 weeks after Treatment ] [ Designated as safety issue: No ]
  • Laboratory Parameters [ Time Frame: During Treatment AND End of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:   300
Study Start Date:   May 2007
Estimated Study Completion Date:   June 2009
Estimated Primary Completion Date:   March 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
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)]

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.

  Eligibility
Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707850

Contacts
Contact: Seyed-Moayed Alavian, Professor     +98 218126 4070     alavian@thc.ir    
Contact: Seyyed Mohammad Miri, M.D.     +98 218126 4070     manager@hepmon.ir    

Locations
Iran, Islamic Republic of
Baqiyatallah Research Center for Gastroenterology and Liver Diseases     Recruiting
      Tehran, Iran, Islamic Republic of, 14155-3651
      Contact: Seyyed Mohammad Miri, M.D.     +98 9123062496     manager@hepmon.ir    
      Principal Investigator: Seyyed Mohammad Miri, M.D.            

Sponsors and Collaborators
Baqiyatallah Medical Sciences University
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Tehran Hepatitis Center
Guilan Research Center for Gastroenterology and Liver Diseases
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    
Principal Investigator:     Pegah Karimi, M.D.     Baqiyatallah Research Center for Gastroenterology and Liver Diseases    
Principal Investigator:     Maryam Keshvari, M.D.     Iranian blood Transfusion Research Center    
Principal Investigator:     Bita Behnava, M.D.     Baqiyatallah Research Center for Gastroenterology and Liver Diseases    
Principal Investigator:     Mohammad Hossein Somi, M.D.     Research Center for Gastroenterology and Hepatology, Tabriz University of Medical Sciences, Tabriz    
Principal Investigator:     Fariborz Mansour-Ghanaei, M.D.     Gastroenterology and Liver Diseases, Gastrointestinal and Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran    
  More Information


Baqiyatallah Research Center for Gastroenterology and Liver Diseases  This link exits the ClinicalTrials.gov site
 

Publications:

Responsible Party:   Baqiyatallah Research Center for Gastroenterology and Liver Diseases ( Professor Seyed-Moayed Alavian )
Study ID Numbers:   BRCGL-08-06
First Received:   June 26, 2008
Last Updated:   June 30, 2008
ClinicalTrials.gov Identifier:   NCT00707850
Health Authority:   Iran: Ministry of Health

Keywords provided by Baqiyatallah Medical Sciences University:
Hepatitis C  
Thalassemia  
Pegasys  
Ribavirin  

Study placed in the following topic categories:
Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Hematologic Diseases
Interferons
Ribavirin
Anemia
Hepatitis, Viral, Human
Anemia, Hemolytic
Thalassemia
Hepatitis
Virus Diseases
Anemia, Hemolytic, Congenital
Digestive System Diseases
Genetic Diseases, Inborn
Hemoglobinopathies
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hemoglobinopathy
Interferon Alfa-2b
Hepatitis C, Chronic

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on October 24, 2008




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