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ADVATE Post Authorization Safety Surveillance
NCT00214734 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice.
Conditions Studied
Interventions
- DRUG rAHF-PFM
Study Locations (20)
Florida
- Children'S Hospital of S.W. Florida — Fort Myers
- BIODORON — Hollywood
- Nemours Children'S Clinic — Jacksonville
- NEMOURS CHILDREN'S CLINIC- Orlando — Orlando
- Tampa Children'S Hospital At St. Joes — Tampa
- University of Southern Florida — Tampa
California
- City of Hope National Medical Center — Duarte
- LONG BEACH MEMORIAL MED Center — Long Beach
- Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology — Los Angeles
- Valley Children'S Hospital — Madera
Illinois
- Rush Presbyterian - St. Lukes Medical Center — Chicago
- Children´s Memorial Hospital — Chicago
Michigan
- University of Michigan Med. Ctr Htc — Ann Arbor
- Henry Ford Hospital — Detroit
Arizona
- PHOENIX CHILDRENS Hospital — Phoenix
Arkansas
- Arkansas Childrens Hospital — Little Rock
Indiana
- Indiana Hemophilia & Thrombosis Center — Indianapolis
Iowa
- University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2004-10-14 |
| Est. Completion | 2007-03-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00214734
The ClinicalTrials.gov registry entry for NCT00214734 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 1 intervention — of which rAHF-PFM is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00214734 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00214734 about?
NCT00214734 is a clinical study titled "ADVATE Post Authorization Safety Surveillance". The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice.
What is the current status of trial NCT00214734?
This trial is currently completed. The enrollment target is 108 participants. The study started on 2004-10-14. Estimated completion is 2007-03-02.
What conditions does trial NCT00214734 study?
This clinical trial studies the following conditions: Hemophilia A. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00214734?
The interventions under investigation include: rAHF-PFM (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00214734?
This trial is sponsored by Baxalta now part of Shire, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00214734 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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