NCT00707772

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

A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Hemophilic Patients With Chronic Hepatitis C Infection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Baqiyatallah Medical Sciences University · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatitis C
• Hemophilia

Interventions

Type	Name	Description
DRUG	PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)	PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: 800 milligram per day (PO)
DRUG	PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)	PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: \[=\<75 kg: 1000 mg; \>75 kg: 1200 mg per day (PO)\]

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2008-07-01
• Last updated: 2009-09-17

Locations

1 site across 1 country: Iran