Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350298
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2006-07-07
Brief 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
Sponsor:
MassBiologics
Organization:
MassBiologics
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 09 sodium chloride as placebo in a 11 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
Detailed Description:
This study is a phase II randomized double-blind placebo-controlled study in patients diagnosed with Clostridium difficile associated disease Patients with Clostridium difficile associated disease will be identified either from stool test results or by physician referral and those 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 to C difficile toxin A GS-CDA1 combined with a human monoclonal antibody to C difficile toxin B MDX-1388 or 09 sodium chloride as placebo in a 11 treatment allocation One hundred patients will be enrolled in the combination monoclonal antibody treated arm and 100 patients will be enrolled in the placebo arm Patients will be evaluated through day 84 10 days after receipt of study infusion for safety and clinical outcomes Blood samples for safety analyses anti-toxin A and anti-toxin B antibody measurements and human anti-human antibody HAHA titers will be collected at scheduled times Study visits will occur on days 3 1 10 2 28 3 56 7 and on day 84 10 days Occurrence of adverse events use of concomitant medications and record of stool output will be assessed at scheduled phone contacts and study visits The first 20 patients enrolled will have a subsequent visit on day 168 14 days for an additional blood collection for HAHA analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None