Pegaferon and Ribavirin for Hepatitis C

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Pegaferon (pegylated interferon alpha 2a) + ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT01137383

DDRC.86.90

Details and patient eligibility

About

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.

Full description

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

Enrollment: 108 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

Treatment group

Experimental group

Treatment:

Drug: Pegaferon (pegylated interferon alpha 2a) + ribavirin