Clinical trial NCT00214734: ADVATE Post Authorization Safety Surveillance
Official title: Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A- An ADVATE Post-authorization Safety Surveillance (PASS) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Baxter BioScience
First posted: 2005-09-22
Enrollment: 108
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE

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.


Eligibility 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

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: PHOENIX CHILDRENS Hospital
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Childrens Hospital
state: Arkansas
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Long Beach
country: United States
facility: LONG BEACH MEMORIAL MED Center
state: California
city: Los Angeles
country: United States
facility: Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology
state: California
city: Madera
country: United States
facility: Valley Children'S Hospital
state: California
city: Fort Myers
country: United States
facility: Children'S Hospital of S.W. Florida
state: Florida
city: Hollywood
country: United States
facility: BIODORON
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children'S Clinic
state: Florida
city: Orlando
country: United States
facility: NEMOURS CHILDREN'S CLINIC- Orlando
state: Florida
city: Tampa
country: United States
facility: Tampa Children'S Hospital At St. Joes
state: Florida
city: Tampa
country: United States
facility: University of Southern Florida
state: Florida
city: Chicago
country: United States
facility: Rush Presbyterian - St. Lukes Medical Center
state: Illinois
city: Chicago
country: United States
facility: Children´s Memorial Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Hemophilia & Thrombosis Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics
state: Iowa
city: New Orleans
country: United States
facility: Tulane Univ Hosp & Clinic
state: Louisiana
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Med. Ctr Htc
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: PHS DEVOS CHILDRENS Hospital
state: Michigan
city: Traverse City
country: United States
facility: MUNSON MED Center
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: St. Louis Children'S Hospital
state: Missouri
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: Ted R. Montoya Hemophilia Treatment Center
state: New Mexico
city: Winston-Salem
country: United States
facility: North Carolina Baptist Hospital, Hematology/Oncology Medical Center Boulevard
state: North Carolina
city: Akron
country: United States
facility: Phs Childrens Hosp Med Ctr Akron
state: Ohio
city: Cincinnati
country: United States
facility: Children´s Hospital Medical Center Pharmacy, Hemophilia Treatment Center
state: Ohio
city: Youngstown
country: United States
facility: Youngstown HTC
state: Ohio
city: Philadelphia
country: United States
facility: Childrens Hosp of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: St. Christopher´s Hospital for Children, Section of Hematology/Oncology
state: Pennsylvania
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Phs-So Tx Hemo Ctr-San Antonio
state: Texas
city: Norfolk
country: United States
facility: Children'S Hospital of the King'S Daughters
state: Virginia
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: