Hemophilia A Clinical Trial
Official title:
Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A- An ADVATE Post-authorization Safety Surveillance (PASS) Study
| NCT number | NCT00214734 |
| Other study ID # | ADVATE PASS |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 14, 2004 |
| Est. completion date | March 2, 2007 |
| Verified date | March 2021 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 108 |
| Est. completion date | March 2, 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Phs Childrens Hosp Med Ctr Akron | Akron | Ohio |
| United States | Ted R. Montoya Hemophilia Treatment Center | Albuquerque | New Mexico |
| United States | University of Michigan Med. Ctr Htc | Ann Arbor | Michigan |
| United States | The Johns Hopkins Hospital | Baltimore | Maryland |
| United States | Children´s Memorial Hospital | Chicago | Illinois |
| United States | Rush Presbyterian - St. Lukes Medical Center | Chicago | Illinois |
| United States | Children´s Hospital Medical Center Pharmacy, Hemophilia Treatment Center | Cincinnati | Ohio |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | City of Hope National Medical Center | Duarte | California |
| United States | Children'S Hospital of S.W. Florida | Fort Myers | Florida |
| United States | PHS DEVOS CHILDRENS Hospital | Grand Rapids | Michigan |
| United States | BIODORON | Hollywood | Florida |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | Indiana Hemophilia & Thrombosis Center | Indianapolis | Indiana |
| United States | University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics | Iowa City | Iowa |
| United States | University of Mississippi Medical Center | Jackson | Mississippi |
| United States | Nemours Children'S Clinic | Jacksonville | Florida |
| United States | University of Tennessee Medical Center | Knoxville | Tennessee |
| United States | Arkansas Childrens Hospital | Little Rock | Arkansas |
| United States | LONG BEACH MEMORIAL MED Center | Long Beach | California |
| United States | Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology | Los Angeles | California |
| United States | Valley Children'S Hospital | Madera | California |
| United States | Robert Wood Johnson University Hospital | New Brunswick | New Jersey |
| United States | Tulane Univ Hosp & Clinic | New Orleans | Louisiana |
| United States | Children'S Hospital of the King'S Daughters | Norfolk | Virginia |
| United States | NEMOURS CHILDREN'S CLINIC- Orlando | Orlando | Florida |
| United States | Childrens Hosp of Philadelphia | Philadelphia | Pennsylvania |
| United States | Presbyterian Medical Center | Philadelphia | Pennsylvania |
| United States | St. Christopher´s Hospital for Children, Section of Hematology/Oncology | Philadelphia | Pennsylvania |
| United States | PHOENIX CHILDRENS Hospital | Phoenix | Arizona |
| United States | St. Louis Children'S Hospital | Saint Louis | Missouri |
| 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 | MUNSON MED Center | Traverse City | Michigan |
| United States | North Carolina Baptist Hospital, Hematology/Oncology Medical Center Boulevard | Winston-Salem | North Carolina |
| United States | Youngstown HTC | Youngstown | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Baxalta now part of Shire | Baxter BioScience |
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