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COUNTY OF SAN MATEO
Inter-Departmental Correspondence
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San Mateo Medical Center
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DATE:
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September 23, 2005
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BOARD MEETING DATE:
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October 18, 2005
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SPECIAL NOTICE/HEARING:
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None
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VOTE REQUIRED:
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Majority
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TO:
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Honorable Board of Supervisors
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FROM:
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Nancy J. Steiger, Chief Executive Officer, San Mateo Medical Center
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SUBJECT:
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Acceptance of a Grant Award from InterMune, Inc.
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RECOMMENDATION:
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Adopt a Resolution:
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A.
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Accepting a grant from the InterMune, Inc. in an amount not to exceed $113,535 to study the safety and/or efficacy of Two Dose Levels of Daily Interferon Alfacon-1 plus Ribavirin in Hepatitis C Infected Patients Who Failed to Achieve Virologic Response After Previous Pegylated Interferon Alfa plus Ribavirin Therapy and during at least 24 Weeks of No Treatment in IRHC-001
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B.
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Authorizing the execution of an Agreement with InterMune, Inc. to conduct the clinical trial for the term February 3, 2005 to January 3, 2008, in an amount not to exceed $113,535
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VISION ALIGNMENT:
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Commitment: Ensure basic health and safety for all.
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Goal 8: Help vulnerable people – the aged, disabled, mentally ill, at risk youth and others – achieve a better quality of life.
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This grant contributes to this commitment and goal by giving SMMC the opportunity to participate in a study to assess the safety and/or efficacy of Two Dose Levels of Daily Interferon Alfacon-1 plus Ribavirin in Hepatitis C Infected Patients Who Failed to Achieve Virologic Response After Previous Pgylated Interferon Alfa plus Ribavirin Therapy and during at least 24 Weeks of No Treatment in IRHC-001.
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Performance Measure(s):
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Measure
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FY2005-06
Projected
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FY2006-07
Projected
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FY2007-08
Projected
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Number of persons recruited and assessed for this study.
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2
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2
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2
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Percent of project client’s dosage comparisons completed for this study.
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100%
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100%
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100%
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Percent of project clients with
positive response to trial medications
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50%
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50%
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50%
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A maximum of two patients will be enrolled in the study. It is anticipated the dosage comparisons for these patients will be completed and that one of these patients will have positive reactions to the medication.
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BACKGROUND:
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The Clinical Trials and Research Unit of the San Mateo County Health Center was established by the Health Services Agency in 2000 in order to provide a mechanism and infrastructure for the conduct of clinical treatment trials and medical or psychosocial research projects for the benefit of the residents of San Mateo County. A preliminary assessment by the Unit staff identified Hepatitis C as a problem affecting many of the County’s patients with HIV. The Clinical Trials and Research Unit discovered that patients are not responding to the current drug treatments. This trial will evaluate patient’s response to this new drug treatment.
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DISCUSSION:
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In October 2004 InterMune, Inc. contacted the Clinical Trials and Research Unit to participate in a Multi-center Study for patients with Hepatitis C. On January 2005, the InterMune, Inc. notified the County that our site was selected to participate in the clinical trial. InterMune, Inc. is allocating $7,569 for each patient enrolled in the study. The County will receive an amount not to exceed $113,535 for fiscal year 2005-2006.
The primary purpose of this study is to assess the safety and/or efficacy of Two Dose Levels of Daily Interferon Alfacon-1 plus Ribavirin in Hepatitis C infected patients who failed to achieve virologic response after previous Pegylated Interferon Alfa plus Ribavirin Therapy and during at least 24 weeks of no treatment in IRHC-001.
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FISCAL IMPACT:
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The grant from InterMune, Inc will not exceed $113,535. Funds are included in San Mateo Medical Center’s FY2005-06 Adopted Budget. The term of the Agreement is February 3, 2005 to January 3, 2008. Administrative oversight, technical assistance, and project monitoring will be provided by existing Clinical Trials and Research staff. There is no net county cost associated with this project.
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