Trial | NCT01137383  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    108
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.
The product is locally produced and needs to be evaluated in terms of efficacy and safety.
Study Started
Dec 31
2007
Primary Completion
Dec 31
2009
Study Completion
Feb 28
2010
Last Update
Jun 30
2010
Estimate

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

  • Other names: Pegaferon

Treatment group Experimental

Criteria 

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
No Results Posted