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Pegaferon and Ribavirin for Hepatitis C

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ClinicalTrials.gov Identifier: NCT01137383
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : June 30, 2010
Sponsor:
Collaborator:
Pars No Tarkib Co
Information provided by:
Tehran University of Medical Sciences

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.

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Locally Manufactured Pegylated Interferon in Hepatitis C Patients
Study Start Date : December 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  1. Adverse drug events [ Time Frame: 18 months from start of treatment ]
    Any adverse event reported by patient or seen in laboratory data



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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: June 30, 2010
Last Verified: June 2010

Keywords provided by Tehran University of Medical Sciences:
Hepatitis C

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