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| Sponsored by: |
ADMA Biologics, Inc. |
| Information provided by: | ADMA Biologics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00632463 |
Purpose
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 |
|
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: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Dose regimen 1
|
Biological: RI-001
Dose 1
|
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2: Experimental
Dose regimen 2
|
Biological: RI-001
Dose 2
|
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3: Placebo Comparator
Placebo
|
Biological: RI-001
Placebo
|
Eligibility
| Ages Eligible for Study: | 3 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mark D Sorrentino, MD MS | 201 478-5552 | sorrentinom@admabio.com |
| United States, Illinois | |||||
| Northwestern University Feinberg School of Medicine | Recruiting | ||||
| Chicago, Illinois, United States, 60611 | |||||
| Principal Investigator: Michael Ison, MD | |||||
| Rush University Medical Center | Recruiting | ||||
| Chicago, Illinois, United States, 60612 | |||||
| Principal Investigator: Forrest Dodson, MD | |||||
| United States, Massachusetts | |||||
| New England Medical Center | Recruiting | ||||
| Boston, Massachusetts, United States, 02111 | |||||
| Principal Investigator: Cody Meissner, MD | |||||
| United States, New Jersey | |||||
| Hackensack University Medical Center | Recruiting | ||||
| Hackensack, New Jersey, United States, 07601 | |||||
| Principal Investigator: Scott Rowley, MD | |||||
| United States, Oklahoma | |||||
| Children's Hospital of Oklahoma | Recruiting | ||||
| Oklahoma City, Oklahoma, United States, 73104 | |||||
| Principal Investigator: Susana Chavez-Bueno, MD | |||||
| United States, Texas | |||||
| Cook Children's Medical Center | Recruiting | ||||
| Fort Worth, Texas, United States, 76104 | |||||
| Principal Investigator: Donald Murphey, MD | |||||
| Children's Medical Center of Dallas | Recruiting | ||||
| Dallas, Texas, United States, 75235 | |||||
| Principal Investigator: Octavio Ramilo, MD | |||||
| Australia, New South Wales | |||||
| Westmead Hospital | Recruiting | ||||
| Westmead, New South Wales, Australia, 2145 | |||||
| Principal Investigator: Tania Sorrell, MD | |||||
| Australia, Queensland | |||||
| Prince Charles Hospital | Recruiting | ||||
| Chermside, Queensland, Australia, 4032 | |||||
| Principal Investigator: Peter Hopkins, MD | |||||
| Australia, South Australia | |||||
| Royal Adelaide Hospital | Recruiting | ||||
| Adelaide, South Australia, Australia, 5000 | |||||
| Principal Investigator: Ian Lewis, MD | |||||
| Australia, Victoria | |||||
| Royal Children's Hospital | Recruiting | ||||
| Melbourne, Victoria, Australia, 3052 | |||||
| Principal Investigator: Karin Tiedemann, MD | |||||
| New Zealand, Auckland | |||||
| Starship Children's Hospital | Recruiting | ||||
| Grafton, Auckland, New Zealand, 1142 | |||||
| Principal Investigator: Lochie Teague, MD | |||||
| New Zealand, Private Bag | |||||
| Christchurch Hospital | Recruiting | ||||
| Christchurch, Private Bag, New Zealand | |||||
| Principal Investigator: Steve Gibbons, MD | |||||
| ADMA Biologics, Inc. |
| Principal Investigator: | Upton Allen, MBBS | Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada |
More Information
| Responsible Party: | ADMA Biologics ( Mark Sorrentino, MD, MS, Chief Medical Officer ) |
| Study ID Numbers: | ADMA-001 |
| First Received: | March 3, 2008 |
| Last Updated: | August 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00632463 |
| Health Authority: | United States: Food and Drug Administration |
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