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Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C
This study has been completed.
First Received: September 8, 2007   Last Updated: January 18, 2009   History of Changes
Sponsors and Collaborators: Tehran Hepatitis Center
Kermanshah University of Medical Sciences
Information provided by: Tehran Hepatitis Center
ClinicalTrials.gov Identifier: NCT00527540
  Purpose

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 Intervention Phase
Hepatitis C
Drug: Pegylated Interferon alpha 2a + Ribavirin
Phase III

MedlinePlus related topics: Hepatitis Hepatitis C
Drug Information available for: Ribavirin Interferon alfa-2a Peginterferon Alfa-2a Interferon alfa-n1 Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C

Further study details as provided by Tehran Hepatitis Center:

Primary Outcome Measures:
  • End of treatment response rate (HCV RNA:Neg) [ Time Frame: End of treatment course ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sustain response rate (HCV RNA:Neg) 6 month after end of treatment [ Time Frame: 6 month after end of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2007
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pegylated Interferon alpha 2a + Ribavirin
    Pegaferon: Ampule, 180 microgram per week Ribaverin: Tablet, 10-15 mg/kg per day
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527540

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

No publications provided

Responsible Party: Tehran Hepatitis Center ( Prof SM Alavian )
Study ID Numbers: THC-10
Study First Received: September 8, 2007
Last Updated: January 18, 2009
ClinicalTrials.gov Identifier: NCT00527540     History of Changes
Health Authority: Iran: Ministry of Health

Study placed in the following topic categories:
Antimetabolites
Interferon-alpha
Interferon Type I, Recombinant
Liver Diseases
Immunologic Factors
Hepatitis, Chronic
Ribavirin
Interferons
Hepatitis, Viral, Human
Angiogenesis Inhibitors
Antiviral Agents
Hepatitis
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Interferon Type I, Recombinant
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Hepatitis, Chronic
Immunologic Factors
Antineoplastic Agents
Ribavirin
Physiological Effects of Drugs
Hepatitis, Viral, Human
Therapeutic Uses
Growth Inhibitors
Hepatitis C
Angiogenesis Modulating Agents
Interferon-alpha
RNA Virus Infections
Growth Substances
Interferons
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Peginterferon alfa-2a
Interferon Alfa-2a
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on May 07, 2009