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| Sponsor: | 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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Dose regimen 1
|
Biological: RI-001
Dose 1
|
|
Experimental: 2
Dose regimen 2
|
Biological: RI-001
Dose 2
|
|
Placebo Comparator: 3
Placebo
|
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| United States, California | |
| University of California San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| All Children's Hospital | |
| St. Petersburg, Florida, United States, 33701 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| Johns Hopkins Medical Center | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11040 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Texas | |
| Children's Medical Center of Dallas | |
| Dallas, Texas, United States, 75235 | |
| Cook Children's Medical Center | |
| Fort Worth, Texas, United States, 76104 | |
| United States, Washington | |
| Seattle Children's Hospital and Regional Medical Center | |
| Seattle, Washington, United States, 98105 | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109 | |
| Canada, Alberta | |
| Alberta Children's Hospital | |
| Calgary, Alberta, Canada, T3B6A8 | |
| Canada, Ontario | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G1X8 | |
| Canada, Quebec | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T1C5 | |
| Hopital Maisonneuve Rosemont | |
| Montreal, Quebec, Canada, H1T2M4 | |
| Principal Investigator: | Upton Allen, MBBS | Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada |
More Information
| Responsible Party: | Mark Sorrentino, MD, MS, Chief Medical Officer, ADMA Biologics |
| ClinicalTrials.gov Identifier: | NCT00632463 History of Changes |
| Other Study ID Numbers: | ADMA-001 |
| Study First Received: | March 3, 2008 |
| Last Updated: | July 21, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Transplant Immunosuppression |
|
Respiratory Tract Infections Common Cold Infection Respiratory Tract Diseases |
Picornaviridae Infections RNA Virus Infections Virus Diseases |