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
Public ClinicalTrials.gov record NCT00350298. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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 Associated Disease
Study identification
- NCT ID
- NCT00350298
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- MassBiologics
- Other
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Interventions
- GS-CDA1/MDX-1388 Biological
- normal saline Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 19, 2006
- Primary completion
- Jun 24, 2008
- Completion
- Jun 24, 2008
- Last update posted
- Feb 8, 2021
2006 – 2008
United States locations
- U.S. sites
- 22
- U.S. states
- 18
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| LAC/USC Medical Center | Los Angeles | California | 90033 | — |
| UCLA CURE Digestive Diseases Center | Los Angeles | California | 90095 | — |
| Kaiser Permanente Vaccine Study Center | Oakland | California | 94612 | — |
| Christiana Care Health Systems | Newark | Delaware | 19718 | — |
| Dr. Kiran C. Patel Research Institute | Tampa | Florida | 33613 | — |
| Idaho Falls Infectious Diseases, PLLC | Idaho Falls | Idaho | 83404 | — |
| Central Indiana Gastroenterology Group | Anderson | Indiana | 46016 | — |
| Chest, Infectious Diseases and Critical Care Assoc., PC | Des Moines | Iowa | 50325 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | — |
| Henry Ford Health System | West Bloomfield | Michigan | 48322 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| Saint James Healthcare | Butte | Montana | 59701 | — |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07754 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| All-Trials Clinical Research, LLC | Winston-Salem | North Carolina | 27103 | — |
| Summa Health System | Akron | Ohio | 44304 | — |
| Remington-Davis Clinical Research | Columbus | Ohio | 43214 | — |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | — |
| St. Lukes Episcopal Hospital | Houston | Texas | 77030 | — |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | — |
| MultiCare Health System Research Services | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00350298, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 8, 2021 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00350298 live on ClinicalTrials.gov.