ADVATE Post Authorization Safety Surveillance
Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A- An ADVATE Post-authorization Safety Surveillance (PASS) Study
1 other identifier
observational
108
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2004
Typical duration for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2004
CompletedFirst Submitted
Initial submission to the registry
September 15, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2007
CompletedMarch 17, 2021
March 1, 2021
September 15, 2005
March 16, 2021
Conditions
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baxalta now part of Shirelead
- Baxter BioSciencecollaborator
Study Sites (37)
PHOENIX CHILDRENS Hospital
Phoenix, Arizona, 85016, United States
Arkansas Childrens Hospital
Little Rock, Arkansas, 72202, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
LONG BEACH MEMORIAL MED Center
Long Beach, California, 90806, United States
Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology
Los Angeles, California, 90027, United States
Valley Children'S Hospital
Madera, California, 93638, United States
Children'S Hospital of S.W. Florida
Fort Myers, Florida, 33908, United States
BIODORON
Hollywood, Florida, 33021, United States
Nemours Children'S Clinic
Jacksonville, Florida, 32207, United States
NEMOURS CHILDREN'S CLINIC- Orlando
Orlando, Florida, 32801, United States
Tampa Children'S Hospital At St. Joes
Tampa, Florida, 33607, United States
University of Southern Florida
Tampa, Florida, 33612, United States
Rush Presbyterian - St. Lukes Medical Center
Chicago, Illinois, 60612, United States
Children´s Memorial Hospital
Chicago, Illinois, 60614, United States
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, 46260, United States
University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics
Iowa City, Iowa, 52242, United States
Tulane Univ Hosp & Clinic
New Orleans, Louisiana, 70112, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21205, United States
University of Michigan Med. Ctr Htc
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
PHS DEVOS CHILDRENS Hospital
Grand Rapids, Michigan, 49503, United States
MUNSON MED Center
Traverse City, Michigan, 49684, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
St. Louis Children'S Hospital
St Louis, Missouri, 63110, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
Ted R. Montoya Hemophilia Treatment Center
Albuquerque, New Mexico, 87131, United States
North Carolina Baptist Hospital, Hematology/Oncology Medical Center Boulevard
Winston-Salem, North Carolina, 27157, United States
Phs Childrens Hosp Med Ctr Akron
Akron, Ohio, 44308, United States
Children´s Hospital Medical Center Pharmacy, Hemophilia Treatment Center
Cincinnati, Ohio, 45229, United States
Youngstown HTC
Youngstown, Ohio, 44501, United States
Childrens Hosp of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
St. Christopher´s Hospital for Children, Section of Hematology/Oncology
Philadelphia, Pennsylvania, 19134-1095, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920-6999, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Phs-So Tx Hemo Ctr-San Antonio
San Antonio, Texas, 78207, United States
Children'S Hospital of the King'S Daughters
Norfolk, Virginia, 23507, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2005
First Posted
September 22, 2005
Study Start
October 14, 2004
Study Completion
March 2, 2007
Last Updated
March 17, 2021
Record last verified: 2021-03