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NCT00632463 · ClinicalTrials.gov registry record · Phase 2
RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness
A Phase 2 study of Lower Respiratory Tract Infection and Upper Respiratory Tract Infection, sponsored by ADMA Biologics.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 19
- Study locations
NCT00632463 is a Phase 2 study of Lower Respiratory Tract Infection and Upper Respiratory Tract Infection that has completed, run by ADMA Biologics. The registered enrollment target is 21 participants, below the 1,463-participant average among 3 other Lower Respiratory Tract Infection trials with a reported enrollment target (99% lower). The trial reports 19 study locations across 15 states.
The verdict
NCT00632463, a Phase 2 study of Lower Respiratory Tract Infection and Upper Respiratory Tract Infection, has completed, sponsored by ADMA Biologics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 19
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL RI-001
Study Locations (19)
New York
- Schneider Children's Hospital - New Hyde Park
- University of Rochester Medical Center - Rochester
Texas
- Children's Medical Center of Dallas - Dallas
- Cook Children's Medical Center - Fort Worth
Washington
- Seattle Children's Hospital and Regional Medical Center - Seattle
- Fred Hutchinson Cancer Research Center - Seattle
Quebec
- Hopital Maisonneuve Rosemont - Montreal
- Hopital Sainte Justine - Montreal
California
- University of California San Francisco - San Francisco
Colorado
- University of Colorado Health Sciences Center - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- All Children's Hospital - St. Petersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2008-02 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00632463
The ClinicalTrials.gov registry entry for NCT00632463 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,463-participant average among 3 other Lower Respiratory Tract Infection trials with a reported enrollment target (99% lower). The listed sponsor is ADMA Biologics, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Lower Respiratory Tract Infection appearing as the primary indexed condition, and to 1 intervention - of which RI-001 is the first listed.
NCT00632463 reports 19 study locations spanning 15 distinct geographic areas - top geographies include New York, Texas, Washington.
Frequently Asked Questions
What is clinical trial NCT00632463 about?
NCT00632463 is a clinical study titled "RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness". 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 in...
What is the current status of trial NCT00632463?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2008-02. Estimated completion is 2010-05.
What conditions does trial NCT00632463 study?
This clinical trial studies the following conditions: Lower Respiratory Tract Infection, Upper Respiratory Tract Infection.
What interventions are being tested in trial NCT00632463?
The interventions under investigation include: RI-001 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00632463?
This trial is sponsored by ADMA Biologics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00632463 being conducted?
This trial has 19 study locations across California, Colorado, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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