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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2009

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.

Interventions

  • 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)]

Arms, Groups and Cohorts

  • Experimental: 1
    • Thalassemic Patients with HCV

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Baqiyatallah Medical Sciences University
  • Collaborator
    • Baqiyatallah Research Center for Gastroenterology and Liver Diseases
  • Provider of Information About this Clinical Study
    • Professor Seyed-Moayed Alavian, Baqiyatallah Research Center for Gastroenterology and Liver Diseases
  • Overall Official(s)
    • Seyed-Moayed Alavian, Professor, Study Chair, Baqiyatallah Research Center for Gastroenterology and Liver Disea
    • Seyyed Mohammad Miri, M.D., Study Director, Baqiyatallah Research Center for Gastroenterology and Liver Disea
    • Pegah Karimi, M.D., Principal Investigator, Baqiyatallah Research Center for Gastroenterology and Liver Diseases
    • Maryam Keshvari, M.D., Principal Investigator, Iranian blood Transfusion Research Center
    • Bita Behnava, M.D., Principal Investigator, Baqiyatallah Research Center for Gastroenterology and Liver Diseases
    • Mohammad Hossein Somi, M.D., Principal Investigator, Research Center for Gastroenterology and Hepatology, Tabriz University of Medical Sciences, Tabriz
    • Fariborz Mansour-Ghanaei, M.D., Principal Investigator, Gastroenterology and Liver Diseases, Gastrointestinal and Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran

References

Harmatz P, Jonas MM, Kwiatkowski JL, Wright EC, Fischer R, Vichinsky E, Giardina PJ, Neufeld EJ, Porter J, Olivieri N; Thalassemia Clinical Research Network. Safety and efficacy of pegylated interferon alpha-2a and ribavirin for the treatment of hepatitis C in patients with thalassemia. Haematologica. 2008 Aug;93(8):1247-51. doi: 10.3324/haematol.12352. Epub 2008 Jun 12.

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