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

Phase 4

Completed

• Conditions: Hepatitis C; Hemophilia
• Interventions: Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)

• Registration Number: NCT00707772
• Lead Sponsor: Baqiyatallah Medical Sciences University

Brief 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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-07-01
• Status Verified: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Last Update Submitted: 2009-09-16
• Last Update Posted: 2009-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)	Other Genotypes (except 2 or 3) in Hemophilic Patients with HCV
1	PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)	Genotype 2 or 3 in Hemophilic Patients with HCV

Primary Outcome Measures

Name	Time	Method
Early Virologic Response	After 12 weeks of Treatment
End of Treatment Response	24 weeks for : Genotype 2 & 3; 48 Weeks for other genotype
Sustained Virologic Response	24 weeks after Treatment
Rapid Virologic Response	One month after Treatment

Secondary Outcome Measures

Name	Time	Method
Tolerability of drugs for whole therapy period	During Treatment
Biochemical response (ALT)	End of Treatment AND 24 weeks after Treatment
Laboratory Parameters	During Treatment AND End of treatment

Trial Locations

Locations (1)

Baqiyatallah Research Center for Gastroenterology and Liver Diseases; 🇮🇷 Tehran, Iran, Islamic Republic of