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Completed

NCT Number: NCT01137383

Pegaferon and Ribavirin for Hepatitis C

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Emam Hospital, Tehran, Iran

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegaferon (pegylated interferon alpha 2a) + ribavirin

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

Other names: Pegaferon

Primary outcomes

  1. Sustained viral response

    Time frame: 6 months after end of treatment

    Negative hepatitis C viral RNA with a highly sensitive assay 6 months after end of treatment

Secondary outcomes

  1. Adverse drug events

    Time frame: 18 months from start of treatment

    Any adverse event reported by patient or seen in laboratory data

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Collaborators

  • Pars No Tarkib Co

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Jun 4, 2010
Registry last updated
Jun 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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