Status:
COMPLETED
Pegaferon and Ribavirin for Hepatitis C
Lead Sponsor:
Tehran University of Medical Sciences
Collaborating Sponsors:
Pars No Tarkib Co
Conditions:
Hepatitis C
Eligibility:
All Genders
15-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of a locally produced 40KD pegylated interferon alpha-2a (Pegaferon) in patients with hepatitis C. 100 patients will be treated using s...
Detailed Description
The product is locally produced and needs to be evaluated in terms of efficacy and safety.
Eligibility Criteria
Inclusion
- Chronic hepatitis C
- Age between 15 and 65
Exclusion
- previous treatment for chronic hepatitis C
- co-infection with human immunodeficiency virus or hepatitis B virus
- major thalassemia or hemophilia
- active drug user
- being treated for major depression or psychosis
- decompensated cirrhosis
- serum creatinine \> 1.5 mg/dL
- solid organ transplant
- untreated thyroid disease
- uncontrolled diabetes mellitus
- uncontrolled autoimmune disease
- advanced cardiac or pulmonary disease.
- planning to become pregnant in the next 1.5 years
- patients with inadequate contraception
- not consenting to the study
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01137383
Start Date
December 1 2007
End Date
February 1 2010
Last Update
June 30 2010
Active Locations (2)
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1
Emam Hospital
Tehran, Iran
2
Shariati Hospital
Tehran, Iran