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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: Completed Phase 2 study of Clostridium Infections, sponsored by MassBiologics.
NCT00350298 is a Phase 2 study of Clostridium Infections that has completed, run by MassBiologics. The registered enrollment target is 200 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Determine if the addition of C. difficile toxin A and toxin B human monoclonal anti-toxin antibodies to standard of care treatment reduces the number of subjects with recurrent CDAD compared to standard of care and placebo. Standard of care treatment is defined as receipt of either metronidazole by mouth or parenterally or receipt of vancomycin by mouth with a standard duration of treatment defined as 10 - 14 days (+ 2 days)). Recurrence of CDAD is defined as the development of a new episode of
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 |
What the finished NCT00350298 record still lists
NCT00350298 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
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 names 20 study sites across 17 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00350298's enrollment target sits among peer trials
200 304th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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