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Pegaferon and Ribavirin for Hepatitis C

This study has been completed.
Sponsor:
Collaborator:
Pars No Tarkib Co
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01137383
First received: June 3, 2010
Last updated: June 28, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: Pegaferon (pegylated interferon alpha 2a) + ribavirin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Locally Manufactured Pegylated Interferon in Hepatitis C Patients

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Sustained viral response [ Time Frame: 6 months after end of treatment ] [ Designated as safety issue: No ]
    Negative hepatitis C viral RNA with a highly sensitive assay 6 months after end of treatment


Secondary Outcome Measures:
  • Adverse drug events [ Time Frame: 18 months from start of treatment ] [ Designated as safety issue: Yes ]
    Any adverse event reported by patient or seen in laboratory data


Enrollment: 108
Study Start Date: December 2007
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group 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 Name: Pegaferon

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137383

Locations
Iran, Islamic Republic of
Emam Hospital
Tehran, Iran, Islamic Republic of
Shariati Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Pars No Tarkib Co
Investigators
Study Chair: Reza Malekzadeh, MD Tehran University of Medical Sciences
  More Information

No publications provided by Tehran University of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shahin Merat, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01137383     History of Changes
Other Study ID Numbers: DDRC.86.90
Study First Received: June 3, 2010
Last Updated: June 28, 2010
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014