Clinical trial
Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C…
NCT00350298 · MassBiologics, Other · Completed
Key facts
| NCT number | NCT00350298 |
|---|---|
| Title | 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 |
| Official title | A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Effectiveness of a Human Monoclonal Antibody to Clostridium Difficile Toxin A (GS-CDA1) and a Human Monoclonal Antibody to Clostridium Difficile Toxin B (MDX-1388) in Patients Being Treated for Clostridium Difficile… |
| Lead sponsor | MassBiologics, Other |
| Collaborators | Medarex Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Clostridium Infections |
| Intervention type | Biological |
| Interventions | GS-CDA1/MDX-1388, normal saline |
| Enrollment | 200 |
| Start date | Jul 20, 2006 |
| Primary completion | Jun 25, 2008 |
| Completion | Jun 25, 2008 |
| First posted | Jul 10, 2006 |
| Last update posted | Feb 9, 2021 |
| Countries | Canada, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: