Trial | NCT00707772  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ribavirin interferon alpha-2b ...

  • Study Participants

    400
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 Started
Mar 31
2007
Primary Completion
Sep 30
2009
Study Completion
Sep 30
2009
Last Update
Sep 17
2009
Estimate

Drug PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)

PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: 800 milligram per day (PO)

  • Other names: Peginterferon Alfa-2a (40KD) Plus COPEGUS

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)]

  • Other names: Peginterferon Alfa-2a (40KD) plus COPEGUS

1 Active Comparator

Genotype 2 or 3 in Hemophilic Patients with HCV

2 Active Comparator

Other Genotypes (except 2 or 3) in Hemophilic Patients with HCV

Criteria 

Inclusion Criteria:

HCV RNA positive
Age older than 12 years

Exclusion Criteria:

Ongoing pregnancy or breast feeding
Hx of 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 SLE
No Results Posted