Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®
Trial Snapshot
- Phase
- Phase 4
- Status
- Suspended
- Sponsor
- PRAECIS Pharmaceuticals Inc.
- Enrollment
- 2,000
- Locations
- 120
- Primary Endpoint
- Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A subject is eligible to participate in the study if he meets the following criteria:
- •Male ≥ 18 years old with advanced symptomatic prostate cancer for whom LHRH agonist therapy is not appropriate and who refuses surgical castration
- •Has at least one of the following:
- •Risk of neurological compromise due to metastases,
- •Ureteral or bladder outlet obstruction due to local encroachment or metastatic disease or
- •Severe bone pain from skeletal metastases persisting on narcotic analgesia
- •Patients or their legal representatives must be able to read, understand and sign an informed consent form to participate in the trial.
Exclusion Criteria
- •Female Patients,
- •Pediatric patients,
- •Patients with known hypersensitivity to any of the components in the abarelix injectable suspension
Outcomes
Primary Outcomes
Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis
Secondary Outcomes
No secondary outcomes reported