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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: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Dose regimen 1
|
Biological: RI-001
Dose 1
|
|
2: Experimental
Dose regimen 2
|
Biological: RI-001
Dose 2
|
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3: Placebo Comparator
Placebo
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Biological: RI-001
Placebo
|
Eligibility| Ages Eligible for Study: | 2 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 |
Show 20 Study Locations| 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 |
| 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 |
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Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
|
Communicable Diseases Respiratory Tract Diseases Respiratory Tract Infections Infection |