ADVATE Post Authorization Safety Surveillance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00214734
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 23, 2017
Baxter BioScience
Information provided by:

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.

Condition or disease Intervention/treatment
Hemophilia A Drug: rAHF-PFM

Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A- An ADVATE Post-authorization Safety Surveillance (PASS) Study
Study Start Date : August 2004
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00214734

  Hide Study Locations
United States, Arizona
Phoenix, Arizona, United States, 85016
United States, Arkansas
Arkansas Childrens Hospital
Little Rock, Arkansas, United States, 72202
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
Long Beach, California, United States, 90806
Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology
Los Angeles, California, United States, 90027
Valley Children'S Hospital
Madera, California, United States, 93638
United States, Florida
Children'S Hospital of S.W. Florida
Fort Myers, Florida, United States, 33908
Hollywood, Florida, United States, 33021
Nemours Children'S Clinic
Jacksonville, Florida, United States, 32207
Orlando, Florida, United States, 32801
Tampa Children'S Hospital At St. Joes
Tampa, Florida, United States, 33607
University of Southern Florida
Tampa, Florida, United States, 33612
United States, Illinois
Rush Presbyterian - St. Lukes Medical Center
Chicago, Illinois, United States, 60612
Children´s Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Indiana
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics
Iowa City, Iowa, United States, 52242
United States, Louisiana
Tulane Univ Hosp & Clinic
New Orleans, Louisiana, United States, 70112
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
United States, Michigan
University of Michigan Med. Ctr Htc
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Grand Rapids, Michigan, United States, 49503
Traverse City, Michigan, United States, 49684
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
St. Louis Children'S Hospital
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
United States, New Mexico
Ted R. Montoya Hemophilia Treatment Center
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
North Carolina Baptist Hospital, Hematology/Oncology Medical Center Boulevard
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Phs Childrens Hosp Med Ctr Akron
Akron, Ohio, United States, 44308
Children´s Hospital Medical Center Pharmacy, Hemophilia Treatment Center
Cincinnati, Ohio, United States, 45229
Youngstown HTC
Youngstown, Ohio, United States, 44501
United States, Pennsylvania
Childrens Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
St. Christopher´s Hospital for Children, Section of Hematology/Oncology
Philadelphia, Pennsylvania, United States, 19134-1095
United States, Tennessee
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920-6999
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Phs-So Tx Hemo Ctr-San Antonio
San Antonio, Texas, United States, 78207
United States, Virginia
Children'S Hospital of the King'S Daughters
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Baxalta now part of Shire
Baxter BioScience
Study Director: Bruce Ewenstein, MD Baxter BioScience Identifier: NCT00214734     History of Changes
Other Study ID Numbers: ADVATE PASS
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: April 2009

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn