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NCT00350298 · ClinicalTrials.gov registry record · Phase 2
Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients With Clostridium Difficile Associated Disease
A Phase 2 study of Clostridium Infections, sponsored by MassBiologics.
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT00350298 is a Phase 2 study of Clostridium Infections that has completed, run by MassBiologics. The registered enrollment target is 200 participants. The trial reports 20 study locations across 17 states.
The verdict
NCT00350298, a Phase 2 study of Clostridium Infections, has completed, sponsored by MassBiologics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
Patients with Clostridium difficile associated disease who fulfill the eligibility criteria will be approached to participate. All study patients must receive standard of care treatment for Clostridium difficile associated disease. Enrolled patients will be randomized to receive a single intravenous solution of a human monoclonal antibody (huMab) to C. difficile toxin A (GS-CDA1) combined with a human monoclonal antibody to C. difficile toxin B (MDX-1388) or 0.9% sodium chloride as placebo in a 1:1 treatment allocation. Patients will be evaluated for safety and clinical outcomes through day 84 +/- 10 days. Occurrence of adverse events, use of concomitant medications, and stool output will be assessed at scheduled phone contacts and study visits. Some patients enrolled will have a subsequent visit on day 168 ± 14 days.
Conditions Studied
Interventions
- BIOLOGICAL GS-CDA1/MDX-1388
- BIOLOGICAL normal saline
Study Locations (20)
California
- LAC/USC Medical Center - Los Angeles
- UCLA CURE Digestive Diseases Center - Los Angeles
- Kaiser Permanente Vaccine Study Center - Oakland
Ohio
- Summa Health System - Akron
- Remington-Davis Clinical Research - Columbus
Delaware
- Christiana Care Health Systems - Newark
Florida
- Dr. Kiran C. Patel Research Institute - Tampa
Idaho
- Idaho Falls Infectious Diseases, PLLC - Idaho Falls
Indiana
- Central Indiana Gastroenterology Group - Anderson
Iowa
- Chest, Infectious Diseases and Critical Care Assoc., PC - Des Moines
Kentucky
- University of Kentucky Medical Center - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2006-07-20 |
| Est. Completion | 2008-06-25 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00350298
The ClinicalTrials.gov registry entry for NCT00350298 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MassBiologics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Clostridium Infections appearing as the primary indexed condition, and to 2 interventions - of which GS-CDA1/MDX-1388 is the first listed.
NCT00350298 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, Ohio, Delaware.
Frequently Asked Questions
What is clinical trial NCT00350298 about?
NCT00350298 is a clinical study titled "Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients With Clostridium Difficile Associated Disease". Patients with Clostridium difficile associated disease who fulfill the eligibility criteria will be approached to participate. All study patients must receive standard of care treatment for Clostridium difficile associated disease. Enrolled patients will be randomized to receive a single intravenous...
What is the current status of trial NCT00350298?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2006-07-20. Estimated completion is 2008-06-25.
What conditions does trial NCT00350298 study?
This clinical trial studies the following conditions: Clostridium Infections.
What interventions are being tested in trial NCT00350298?
The interventions under investigation include: GS-CDA1/MDX-1388 (BIOLOGICAL), normal saline (BIOLOGICAL).
Who is sponsoring clinical trial NCT00350298?
This trial is sponsored by MassBiologics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00350298 being conducted?
This trial has 20 study locations across California, Delaware, Florida, Idaho, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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