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Sponsored by: |
PRAECIS Pharmaceuticals Inc. |
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Information provided by: | PRAECIS Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT00103623 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Plenaxis |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis® |
Estimated Enrollment: | 2000 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | December 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A subject is eligible to participate in the study if he meets the following criteria:
Has at least one of the following:
Exclusion Criteria:
Study Director: | Gerald Riedel, PhD | PRAECIS PHARMACEUTICALS |
Study ID Numbers: | 149-IV-01 |
Study First Received: | February 11, 2005 |
Last Updated: | September 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00103623 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Advanced Symptomatic Prostate Cancer Advanced Symptomatic Prostate Cancer |
Hypersensitivity Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |