Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
108 participants
INTERVENTIONAL
2007-12-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group
Pegaferon (pegylated interferon alpha 2a) + ribavirin
pegylated interferon 180 micrograms subcutaneously weekly - ribavirin (oral, in two divided daily doses) 800 mg for genotype 2 and 3, 1000 or 1200mg (weight less than or greater than 75kg) for genotypes 1 and 4 - Duration: 24 weeks for genotype 2 and 3, 48 weeks for genotypes 1 and 4
Interventions
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Pegaferon (pegylated interferon alpha 2a) + ribavirin
pegylated interferon 180 micrograms subcutaneously weekly - ribavirin (oral, in two divided daily doses) 800 mg for genotype 2 and 3, 1000 or 1200mg (weight less than or greater than 75kg) for genotypes 1 and 4 - Duration: 24 weeks for genotype 2 and 3, 48 weeks for genotypes 1 and 4
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 15 and 65
Exclusion Criteria
* 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
15 Years
65 Years
ALL
No
Sponsors
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Pars No Tarkib Co
UNKNOWN
Tehran University of Medical Sciences
OTHER
Responsible Party
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Tehran University of Medical Sciences
Principal Investigators
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Reza Malekzadeh, MD
Role: STUDY_CHAIR
Tehran University of Medical Sciences
Locations
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Emam Hospital
Tehran, , Iran
Shariati Hospital
Tehran, , Iran
Countries
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References
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Jabbari H, Bayatian A, Sharifi AH, Zaer-Rezaee H, Fakharzadeh E, Asadi R, Zamini H, Shahzamani K, Merat S, Nassiri-Toosi M. Safety and efficacy of locally manufactured pegylated interferon in hepatitis C patients. Arch Iran Med. 2010 Jul;13(4):306-12.
Other Identifiers
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DDRC.86.90
Identifier Type: -
Identifier Source: org_study_id