ADVATE Post Authorization Safety Surveillance
- Conditions
- Hemophilia A
- Registration Number
- NCT00214734
- Lead Sponsor
- Baxalta now part of Shire
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 108
- 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
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Childrens Hosp of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
LONG BEACH MEMORIAL MED Center
🇺🇸Long Beach, California, United States
BIODORON
🇺🇸Hollywood, Florida, United States
MUNSON MED Center
🇺🇸Traverse City, Michigan, United States
Children´s Memorial Hospital
🇺🇸Chicago, Illinois, United States
Indiana Hemophilia & Thrombosis Center
🇺🇸Indianapolis, Indiana, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
PHOENIX CHILDRENS Hospital
🇺🇸Phoenix, Arizona, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Children´s Hospital Medical Center Pharmacy, Hemophilia Treatment Center
🇺🇸Cincinnati, Ohio, United States
Phs-So Tx Hemo Ctr-San Antonio
🇺🇸San Antonio, Texas, United States
Tampa Children'S Hospital At St. Joes
🇺🇸Tampa, Florida, United States
University of Southern Florida
🇺🇸Tampa, Florida, United States
University of Michigan Med. Ctr Htc
🇺🇸Ann Arbor, Michigan, United States
Arkansas Childrens Hospital
🇺🇸Little Rock, Arkansas, United States
Valley Children'S Hospital
🇺🇸Madera, California, United States
Children'S Hospital of S.W. Florida
🇺🇸Fort Myers, Florida, United States
Rush Presbyterian - St. Lukes Medical Center
🇺🇸Chicago, Illinois, United States
Tulane Univ Hosp & Clinic
🇺🇸New Orleans, Louisiana, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics
🇺🇸Iowa City, Iowa, United States
PHS DEVOS CHILDRENS Hospital
🇺🇸Grand Rapids, Michigan, United States
St. Louis Children'S Hospital
🇺🇸Saint Louis, Missouri, United States
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
North Carolina Baptist Hospital, Hematology/Oncology Medical Center Boulevard
🇺🇸Winston-Salem, North Carolina, United States
Ted R. Montoya Hemophilia Treatment Center
🇺🇸Albuquerque, New Mexico, United States
Phs Childrens Hosp Med Ctr Akron
🇺🇸Akron, Ohio, United States
Youngstown HTC
🇺🇸Youngstown, Ohio, United States
St. Christopher´s Hospital for Children, Section of Hematology/Oncology
🇺🇸Philadelphia, Pennsylvania, United States
Children'S Hospital of the King'S Daughters
🇺🇸Norfolk, Virginia, United States
Nemours Children'S Clinic
🇺🇸Jacksonville, Florida, United States
Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology
🇺🇸Los Angeles, California, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
NEMOURS CHILDREN'S CLINIC- Orlando
🇺🇸Orlando, Florida, United States