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

Baqiyatallah Medical Sciences University

Status and phase: Completed; Phase 4

Conditions: Hepatitis C; Hemophilia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00707772

BRCGL-07-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

1

Active Comparator group

Description:

Genotype 2 or 3 in Hemophilic Patients with HCV

Treatment:

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

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

2

Active Comparator group

Description:

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

Treatment:

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

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