ADVATE Post Authorization Safety Surveillance - Full Text View

Purpose

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	Intervention
Hemophilia A	Drug: rAHF-PFM

Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Hemophilia

Drug Information available for: Kogenate Moroctocog Alfa Advate

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Estimated Enrollment:	450
Study Start Date:	August 2004
Estimated Study Completion Date:	January 2007

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214734

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Locations

United States, Arizona
PHOENIX CHILDRENS Hospital
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 MEMORIAL MED Center
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
BIODORON
Hollywood, Florida, United States, 33021
Nemours Children'S Clinic
Jacksonville, Florida, United States, 32207
NEMOURS CHILDREN'S CLINIC- Orlando
Orlando, Florida, United States, 32801
University of Southern Florida
Tampa, Florida, United States, 33612
Tampa Children'S Hospital At St. Joes
Tampa, Florida, United States, 33607
United States, Illinois
Children´s Memorial Hospital
Chicago, Illinois, United States, 60614
Rush Presbyterian - St. Lukes Medical Center
Chicago, Illinois, United States, 60612
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
PHS DEVOS CHILDRENS Hospital
Grand Rapids, Michigan, United States, 49503
MUNSON MED Center
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
St. 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
St. Christopher´s Hospital for Children, Section of Hematology/Oncology
Philadelphia, Pennsylvania, United States, 19134-1095
Childrens Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
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

Baxter Healthcare Corporation

Baxter BioScience

Investigators

Study Director:

Bruce Ewenstein, MD

Baxter BioScience

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00214734 History of Changes
Other Study ID Numbers:	ADVATE PASS
Study First Received:	September 15, 2005
Last Updated:	April 1, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases

Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 16, 2013