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Sponsors and Collaborators: |
Tehran Hepatitis Center Kermanshah University of Medical Sciences |
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Information provided by: | Tehran Hepatitis Center |
ClinicalTrials.gov Identifier: | NCT00527540 |
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 |
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Hepatitis C |
Drug: Pegylated Interferon alpha 2a + Ribavirin |
Phase III |
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 |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Iran, Islamic Republic of | |
Tehran Hepatitis Center | |
Tehran, Iran, Islamic Republic of |
Study Chair: | Seyed M Alavian, Prof. | Tehran Hepatitis Center |
Principal Investigator: | Behzad Hajarizadeh, MD | Tehran Hepatitis Center |
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 |
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 |
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 |