Completed PHASE2 INTERVENTIONAL 2-arm NCT00350298

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 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

Sponsor: MassBiologics

Conditions Clostridium Infections

Interventions GS-CDA1/MDX-1388 normal saline

Updated 9 times since 2017 Last updated: Jan 21, 2021 Started: Jul 20, 2006 Primary completion: Jun 25, 2008 Completion: Jun 25, 2008

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Clostridium Infections and is currently completed. MassBiologics leads this study, which shows 9 recorded versions since 2006 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Mar 2021 — Jul 2024 [monthly]

Completed PHASE2
Jan 2021 — Mar 2021 [monthly]

Completed PHASE2

▶ Show 4 earlier versions

Apr 2019 — Jan 2021 [monthly]

Completed PHASE2
Jun 2018 — Apr 2019 [monthly]

Completed PHASE2
Feb 2017 — Jun 2018 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Jul 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

MassBiologics
Medarex

Data source: MassBiologics

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Akron, United States , Anderson, United States , Butte, United States , Calgary, Canada , Chicoutimi, Canada , Columbus, United States , Des Moines, United States , Houston, United States , Idaho Falls, United States , Kansas City, United States and 18 more locations