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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00707850
Recruitment Status : Completed
First Posted : July 1, 2008
Last Update Posted : August 31, 2010
Sponsor:
Collaborators:
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Tehran Hepatitis Center
Guilan University of Medical Sciences
Tabriz Research Center for Gastroenterology and Liver Diseases
Information provided by:
Baqiyatallah Medical Sciences University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C Thalassemia Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Thalassemic Patients With Chronic Hepatitis C Infection
Study Start Date : May 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Peginterferon Alfa-2a (40KD) plus COPEGUS


Outcome Measures
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Primary Outcome Measures :
  1. Early Virologic Response [ Time Frame: After 12 weeks of Treatment ]
  2. End of Treatment Response [ Time Frame: 48 Weeks ]
  3. Sustained Virologic Response [ Time Frame: 24 weeks after Treatment ]
  4. Rapid Virologic Response [ Time Frame: One month after Treatment ]

Secondary Outcome Measures :
  1. Tolerability of drugs for whole therapy period [ Time Frame: During Treatment ]
  2. Biochemical response (ALT) [ Time Frame: End of Treatment AND 24 weeks after Treatment ]
  3. Laboratory Parameters [ Time Frame: During Treatment AND End of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707850


Locations
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Iran, Islamic Republic of
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Tehran, Iran, Islamic Republic of, 14155-3651
Sponsors and Collaborators
Baqiyatallah Medical Sciences University
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Tehran Hepatitis Center
Guilan University of Medical Sciences
Tabriz Research Center for Gastroenterology and Liver Diseases
Investigators
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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
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Publications:

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Responsible Party: Professor Seyed-Moayed Alavian, Baqiyatallah Research Center for Gastroenterology and Liver Diseases
ClinicalTrials.gov Identifier: NCT00707850    
Other Study ID Numbers: BRCGL-08-06
First Posted: July 1, 2008    Key Record Dates
Last Update Posted: August 31, 2010
Last Verified: September 2009
Keywords provided by Baqiyatallah Medical Sciences University:
Hepatitis C
Thalassemia
Pegasys
Ribavirin
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Thalassemia
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
 Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs