ADVATE Post Authorization Safety Surveillance

Completed

Conditions studied: Hemophilia A

In brief

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.

Key facts

Study ID

NCT00214734

Run by

Baxalta now part of Shire

People needed

108

Starts

2004-10-14

Expected to finish

2007-03-02

Last updated by the study team

2021-03-17

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Subject has moderate or severe hemophilia A (baseline FVIII less than or equal to 5%)
• Subject currently has no measurable FVIII inhibitor titer greater than or equal to 1 BU (Bethesda or Nijmegen method)
• Subject has been prescribed ADVATE by their treating physician
• Subject may be of any age
• Subject or parent/legally authorized representative has provided written informed consent

You may not qualify if…

• None

Where it is running

• PHOENIX CHILDRENS Hospital — Phoenix, Arizona, United States
• Arkansas Childrens Hospital — Little Rock, Arkansas, United States
• City of Hope National Medical Center — Duarte, California, United States
• LONG BEACH MEMORIAL MED Center — Long Beach, California, United States
• Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology — Los Angeles, California, United States
• Valley Children'S Hospital — Madera, California, United States
• Children'S Hospital of S.W. Florida — Fort Myers, Florida, United States
• BIODORON — Hollywood, Florida, United States
• Nemours Children'S Clinic — Jacksonville, Florida, United States
• NEMOURS CHILDREN'S CLINIC- Orlando — Orlando, Florida, United States
• Tampa Children'S Hospital At St. Joes — Tampa, Florida, United States
• University of Southern Florida — Tampa, Florida, United States
• Rush Presbyterian - St. Lukes Medical Center — Chicago, Illinois, United States
• Children´s Memorial Hospital — Chicago, Illinois, United States
• Indiana Hemophilia & Thrombosis Center — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics — Iowa City, Iowa, United States
• Tulane Univ Hosp & Clinic — New Orleans, Louisiana, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Michigan Med. Ctr Htc — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• PHS DEVOS CHILDRENS Hospital — Grand Rapids, Michigan, United States
• MUNSON MED Center — Traverse City, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• St. Louis Children'S Hospital — St Louis, Missouri, United States
• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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