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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.
Sponsor:
Collaborator:
Kermanshah University of Medical Sciences
Information provided by:
Tehran Hepatitis Center
ClinicalTrials.gov Identifier:
NCT00527540
First received: September 8, 2007
Last updated: January 18, 2009
Last verified: January 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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

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

ClinicalTrials.gov processed this record on May 23, 2013