Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Tehran, Tehran Province, 14155-3651, Iran
NCT Number: NCT00707850
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.
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Notify Me12 year and older
All sexes
Interventional
Phase 4
Tehran, Tehran Province, 14155-3651, Iran
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: After 12 weeks of Treatment
Time frame: 48 Weeks
Time frame: 24 weeks after Treatment
Time frame: One month after Treatment
Time frame: During Treatment
Time frame: End of Treatment AND 24 weeks after Treatment
Time frame: During Treatment AND End of treatment
Baqiyatallah Medical Sciences University
Other
A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Thalassemic Patients With Chronic Hepatitis C Infection
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