Pegaferon and Ribavirin for Hepatitis C

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137383
• Other study ID #: DDRC.86.90
• Status: Completed
• Phase: Phase 3
• First received: June 3, 2010
• Last updated: June 28, 2010
• Start date: December 2007
• Est. completion date: February 2010

Study information

• Verified date: June 2010
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Emam Hospital	Tehran
Iran, Islamic Republic of	Shariati Hospital	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	Pars No Tarkib Co

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained viral response	Negative hepatitis C viral RNA with a highly sensitive assay 6 months after end of treatment	6 months after end of treatment	No
Secondary	Adverse drug events	Any adverse event reported by patient or seen in laboratory data	18 months from start of treatment	Yes