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Sponsored by: |
ADMA Biologics, Inc. |
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Information provided by: | ADMA Biologics, Inc. |
ClinicalTrials.gov Identifier: | NCT00632463 |
RSV infections can develop into serious, life threatening conditions among immunocompromised patients. The objective of this study (ADMA 001) is to evaluate the safety and efficacy of RI-001 for the prevention of lower respiratory tract infections in immunocompromised patients identified as being infected with RSV in the upper respiratory tract.
Condition | Intervention | Phase |
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Upper Respiratory Tract Infection Lower Respiratory Tract Infection |
Biological: RI-001 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment |
Official Title: | RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness |
Estimated Enrollment: | 30 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Dose regimen 1
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Biological: RI-001
Dose 1
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2: Experimental
Dose regimen 2
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Biological: RI-001
Dose 2
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3: Placebo Comparator
Placebo
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Biological: RI-001
Placebo
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Ages Eligible for Study: | 2 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mark D Sorrentino, MD MS | 201 478-5552 | sorrentinom@admabio.com |
Principal Investigator: | Upton Allen, MBBS | Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada |
Responsible Party: | ADMA Biologics ( Mark Sorrentino, MD, MS, Chief Medical Officer ) |
Study ID Numbers: | ADMA-001 |
Study First Received: | March 3, 2008 |
Last Updated: | February 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00632463 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Transplant Immunosuppression |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Communicable Diseases Respiratory Tract Diseases Respiratory Tract Infections Infection |