Hemophilic patients are a known high risk groups for acquiring the hepatitis C. The surveillance data from Ministry Of Health in IR.Iran had shown that 60% of them are infected with HCV infection. We are trying the PEGASYS plus Ribavirin in Hemophilic patients with HCV.
The investigators enroll 400 patients into the study. The patients receive PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 800 microgram for Genotype 2 and 3 and 1000 milligram for weight less than 75 kg and 1200 milligram for more than 75 kg. The duration of protocol is depends on genotypes of virus. In genotype 1 and 4, for 48 week and in genotypes 2 and 3 , for 24 weeks. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA 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. We have omitted the liver biopsy in the patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: 800 milligram per day (PO)
PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: \[=\<75 kg: 1000 mg; \>75 kg: 1200 mg per day (PO)\]
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Tehran, Tehran Province, Iran
Early Virologic Response
Time frame: After 12 weeks of Treatment
End of Treatment Response
Time frame: 24 weeks for : Genotype 2 & 3; 48 Weeks for other genotype
Sustained Virologic Response
Time frame: 24 weeks after Treatment
Rapid Virologic Response
Time frame: One month after Treatment
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
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