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Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT00527540
Recruitment Status : Completed
First Posted : September 11, 2007
Last Update Posted : January 21, 2009
Information provided by:

Study Description
Brief Summary:
Pegylation of interferon prolongs the medication half-life which has resulted in Pegylated Interferon (PEG-IFN) as the new modality for treatment of chronic hepatitis C. We current this clinical trial to assess the efficacy and safety of domestic PEG-IFN alpha-2a (Pegaferon®) in the patients with chronic hepatitis C.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Pegylated Interferon alpha 2a + Ribavirin Phase 3

Detailed Description:
We enroll 50 patients in to the study. The patients receive Pegaferon® 180 micgr per week plus ribavirin 10-15mg/kg per day. The patients are visited every 4 weeks with biochemistry lab tests. They are checked with quantitative HCV PCR on the third month after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C
Study Start Date : February 2007
Primary Completion Date : June 2008
Study Completion Date : December 2008

Arms and Interventions

Intervention Details:
    Drug: Pegylated Interferon alpha 2a + Ribavirin
    Pegaferon: Ampule, 180 microgram per week Ribaverin: Tablet, 10-15 mg/kg per day
    Other Name: Pegaferon

Outcome Measures

Primary Outcome Measures :
  1. End of treatment response rate (HCV RNA:Neg) [ Time Frame: End of treatment course ]

Secondary Outcome Measures :
  1. Sustain response rate (HCV RNA:Neg) 6 month after end of treatment [ Time Frame: 6 month after end of treatment ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HCV RNA: Positive
  • Biopsy approved in genotype 1
  • Age older than 18 yrs

Exclusion Criteria:

  • ongoing pregnancy or breast feeding
  • Hx of hemochromatosis
  • Hx of metabolic liver dis.
  • Hx of HCC
  • Hx of autoimmune hepatitis
  • Hx of alcoholic liver dis.
  • Hx of bleeding from esophageal varices
  • ongoing systemic anti-viral or anti-neoplasmic treatment
  • Hx of treatment with an anti-depressant medication at therapeutic doses for at least 3 months at any pervious time
  • Hx of treatment with an tranquilizer at therapeutic doses for psychosis for at least 3 months at any pervious time
  • Hx of hospitalization for psychiatric dis.
  • Hx of suicidal attempt
  • Hx of IBD
  • Hx of SLE
  • Hx of scleroderma
  • Hx of rheumatoid arthritis
  • Hx of ITP
  • Hx of autoimmune hemolytic anemia
  • Hx of severe psoriasis
  • Hx of chronic pulmonary dis. associated with functional limitation
  • Hx of MI or unstable angina
  • Hx of arrhythmia requiring ongoing treatment
  • Hx of functional class III or IV
  • Hx of severe seizure dis. or current anti-convulsant use
  • Hx of organ transplantation with existing functional graft
  • Hx of severe retinopathy
  • Hx of Thalassemia
  • Hx of spherocytosis
  • Hx of cerebrovascular dis.
Contacts and Locations

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): NCT00527540

Iran, Islamic Republic of
Tehran Hepatitis Center
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran Hepatitis Center
Kermanshah University of Medical Sciences
Study Chair: Seyed M Alavian, Prof. Tehran Hepatitis Center
Principal Investigator: Behzad Hajarizadeh, MD Tehran Hepatitis Center
More Information

Responsible Party: Prof SM Alavian, Tehran Hepatitis Center
ClinicalTrials.gov Identifier: NCT00527540     History of Changes
Other Study ID Numbers: THC-10
First Posted: September 11, 2007    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: January 2009

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