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| Sponsor: | Aga Khan University |
|---|---|
| Information provided by: | Aga Khan University |
| ClinicalTrials.gov Identifier: | NCT00538811 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
|
1: Experimental
Interferon alpha, ribavirin, interferon gamma
|
Drug: interferon alpha-2b, ribavirin, interferon-gamma, |
|
2: Active Comparator
Interferon alpha, ribavirin, amantadine
|
Drug: interferon alpha-2b, ribavirin, amantadine |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | 648-Med |
| Study First Received: | October 2, 2007 |
| Last Updated: | October 2, 2007 |
| ClinicalTrials.gov Identifier: | NCT00538811 History of Changes |
| Health Authority: | Pakistan: Research Ethics Committee |
|
Antimetabolites Anti-Infective Agents Neurotransmitter Agents Interferon Type I, Recombinant Liver Diseases Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Interferon Type II Immunologic Factors Anti-Dyskinesia Agents Antineoplastic Agents Ribavirin Physiological Effects of Drugs Antiparkinson Agents Hepatitis, Viral, Human |
Sensory System Agents Therapeutic Uses Analgesics Growth Inhibitors Hepatitis C Angiogenesis Modulating Agents Interferon-alpha RNA Virus Infections Growth Substances Interferons Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Virus Diseases Hepatitis |