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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00707772

Enrollment

400

Registered

2008-07-01

Start date

2007-03-31

Completion date

2009-09-30

Last updated

2009-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia, Hepatitis C

Keywords

Hepatitis C, Hemophilia, Pegasys, Ribavirin

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.

Interventions

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

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026