NCT00103623

The Plenaxis® Experience Study

Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®

• Status: Suspended
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,000 (planned)
• Sponsor: PRAECIS Pharmaceuticals Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 2,000 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Plenaxis

Timeline

• Start date: 2004-06-01
• Completion: 2008-12-01
• First posted: 2005-02-14
• Last updated: 2006-09-19

Locations

60 sites across 1 country: United States