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Sponsored by: |
Aga Khan University |
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Information provided by: | Aga Khan University |
ClinicalTrials.gov Identifier: | NCT00538811 |
When administered simultaneously, interferon-alpha 2b + interferon-gamma result in dramatic antiviral synergy.Ribavirin has shown to enhance interferon-gamma levels in patients with chronic hepatitis C treated with interferon-alpha. Enhancement of immune responses, especially those related to type-1 T helper cell activity, may contribute to better efficacy in combining ribavirin with IFN-alpha for treatment of chronic hepatitis C. The aim of the present study is to evaluate the efficacy and safety of a triple regimen, a combination treatment with Interferon gamma, Interferon alfa-2b plus Ribavirin in patients who have not previously responded to interferon alpha in combination of ribavirin.
Condition | Intervention | Phase |
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Hepatitis C Genotype 3 Non-Responders Relapsers |
Drug: interferon alpha-2b, ribavirin, interferon-gamma, Drug: interferon alpha-2b, ribavirin, amantadine |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Interferon-Gamma With Interferon Alpha and Ribavirin for Hepatitis C Patients Who Are Non-Responders to Interferon Alpha Plus Ribavirin |
Estimated Enrollment: | 40 |
Arms | Assigned Interventions |
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1: Experimental
Interferon alpha, ribavirin, interferon gamma
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Drug: interferon alpha-2b, ribavirin, interferon-gamma, |
2: Active Comparator
Interferon alpha, ribavirin, amantadine
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Drug: interferon alpha-2b, ribavirin, amantadine |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pakistan | |
The Aga Khan University Hospital | Recruiting |
Karachi, Pakistan, 74800 | |
Contact: Zaigham Abbas, FCPS, FACG +92-21-4930051 zaigham@akunet.org | |
Contact: Javed Yakoob, PhD +92-21-4930051 yakoobjaved@hotmail.com | |
Principal Investigator: Zaigham Abbas, FACG | |
Sub-Investigator: Saeed Hamid, FRCP | |
Sub-Investigator: Wasim Jafri, FRCP | |
Medicare Clinic | Recruiting |
Karachi, Pakistan, 74800 | |
Contact: Zaigham Abbas, FCPS +92-21-4934294 zaigham@akunet.org | |
Principal Investigator: Zaigham Abbas, FACG |
Principal Investigator: | Zaigham Abbas, FCPS, FACG | The Aga Khan University Hospital |
Study ID Numbers: | 648-Med |
Study First Received: | October 2, 2007 |
Last Updated: | October 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00538811 |
Health Authority: | Pakistan: Research Ethics Committee |
Interferon-alpha Interferon Type I, Recombinant Liver Diseases Interferon Type II Ribavirin Interferons Hepatitis, Viral, Human Hepatitis |
Virus Diseases Digestive System Diseases Hepatitis C Interferon Alfa-2a Amantadine Interferon Alfa-2b Interferon-gamma, Recombinant |
Antimetabolites Anti-Infective Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Immunologic Factors Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |