Pegasys® Plus Ribavirin in Thalassemic Patients With Hepatitis C Virus Infection
A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Thalassemic Patients With Chronic Hepatitis C Infection
Sponsor study identifier
interventional
300
1 country
1
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2009
Actual (reported)Study Completion
September 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
June 26, 2008
Actual (reported)July 1, 2008
Actual (reported)September 2009
Actual (reported)September 2009
Actual (reported)Early Virologic Response
After 12 weeks of Treatment
End of Treatment Response
48 Weeks
Sustained Virologic Response
24 weeks after Treatment
Rapid Virologic Response
One month after Treatment
Tolerability of drugs for whole therapy period
During Treatment
Biochemical response (ALT)
End of Treatment AND 24 weeks after Treatment
Laboratory Parameters
During Treatment AND End of treatment
Thalassemic Patients with HCV
PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: \[=\<75 kg: 1000 mg; \>75 kg: 1200 mg per day (PO)\]
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Tehran, Tehran Province, 14155-3651, Iran
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.
Seyed-Moayed Alavian, Professor
Baqiyatallah Research Center for Gastroenterology and Liver Disea
Seyyed Mohammad Miri, M.D.
Baqiyatallah Research Center for Gastroenterology and Liver Disea
Pegah Karimi, M.D.
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Maryam Keshvari, M.D.
Iranian blood Transfusion Research Center
First Submitted
June 26, 2008
First Posted
July 1, 2008
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2009
Actual (reported)Contact the study team to confirm eligibility.
Bita Behnava, M.D.
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Mohammad Hossein Somi, M.D.
Research Center for Gastroenterology and Hepatology, Tabriz University of Medical Sciences, Tabriz
Fariborz Mansour-Ghanaei, M.D.
Gastroenterology and Liver Diseases, Gastrointestinal and Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran
Study Completion
September 2009
Actual (reported)Last Updated
August 31, 2010
Record last verified: 2009-09
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Source: ClinicalTrials.gov.
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