Pegaferon and Ribavirin for Hepatitis C

NCT ID: NCT01137383

Last Updated: 2010-06-30

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-02-28

Brief Summary

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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 standard guidelines for hepatitis C. Response to treatment and side effects will be recorded.

Detailed Description

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The product is locally produced and needs to be evaluated in terms of efficacy and safety.

Conditions

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Hepatitis C

Keywords

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Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

Group Type EXPERIMENTAL

Pegaferon (pegylated interferon alpha 2a) + ribavirin

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Pegaferon

Eligibility Criteria

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Inclusion Criteria

* Chronic hepatitis C
* Age between 15 and 65

Exclusion Criteria

* 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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pars No Tarkib Co

UNKNOWN

Sponsor Role collaborator

Tehran University of Medical Sciences

OTHER

Sponsor Role lead

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

Site Status

Shariati Hospital

Tehran, , Iran

Site Status

Countries

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Iran

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.

Reference Type DERIVED
PMID: 20597564 (View on PubMed)

Other Identifiers

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DDRC.86.90

Identifier Type: -

Identifier Source: org_study_id