Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103623
Status:
SUSPENDED
Last Update Posted:
2006-09-19
First Post:
2005-02-11
Brief Title:
The Plenaxis Experience Study
Sponsor:
PRAECIS Pharmaceuticals Inc
Organization:
PRAECIS Pharmaceuticals Inc
Study Overview
Official Title:
Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis
Status:
SUSPENDED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Praecis is currently conducting a 2000 patient Experience Study this is a Phase IV commitment postmarketing safety study in the Food and Drug Administration FDA indicated population of patients receiving Plenaxis The purpose of the study is to estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis and to determine whether the hazard rate changes over time
Detailed Description:
This is a postmarketing patient safety study in the FDA indicated population of patients receiving Plenaxis On a quarterly basis patients enrolled in the Plenaxis Experience Study will have their charts audited to record the number of immediate-onset systemic allergic reactions that may occur while receiving Plenaxis The study will close when 2000 patients have been enrolled If immediate onset allergic reactions occur patients may be eligible to enroll in a second protocol skin testing in patients who experience an immediate onset allergic reaction Collection of all immediate-onset systemic allergic reactions will continue for each patient enrolled in the study until the patient discontinues Plenaxis for any reason the patient withdraws consent to continue in the study or the patient is lost to follow-up
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