Pegaferon and Ribavirin for Hepatitis C

Safety and Efficacy of Locally Manufactured Pegylated Interferon in Hepatitis C Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01137383

Enrollment

108

Registered

2010-06-04

Start date

2007-12-31

Completion date

2010-02-28

Last updated

2010-06-30

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

Conditions

Hepatitis C

Keywords

Hepatitis C

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

Detailed description

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

Interventions

DRUGPegaferon (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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Sustained viral response	6 months after end of treatment	Negative hepatitis C viral RNA with a highly sensitive assay 6 months after end of treatment

Secondary

Measure	Time frame	Description
Adverse drug events	18 months from start of treatment	Any adverse event reported by patient or seen in laboratory data

Countries

Iran

Outcome results

None listed

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