Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A subjects. The study consists of 2 parts: Part 1 is a pharmacokinetic and safety study, and Part 2 is an evaluation of efficacy and safety. The study is open to patients who completed Baxter Study 069901.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antihemophilic factor, recombinant, manufactured protein-free | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Terminal phase half-life for Recombinant Antihemophilic Factor (rAHF-PFM) | Within 30 minutes prior to the pharmacokinetic infusion and at 1 hour ± 5 minutes, 9 ± 1 hour, 24 ± 2 hours, and 48 ± 2 hours after the infusion. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mountain States Regional Hemophilia and Thrombosis Center | Aurora | Colorado | 80045 | United States | ||
| Childrens Healthcare of Atlanta Blood Bank |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19216617 | Derived | Shapiro A, Gruppo R, Pabinger I, Collins PW, Hay CR, Schroth P, Casey K, Patrone L, Ehrlich H, Ewenstein BM. Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A. Expert Opin Biol Ther. 2009 Mar;9(3):273-83. doi: 10.1517/14712590902729392. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Comprehensive Bleeding Disorders Center | Peoria | Illinois | 61614 | United States |
| Indiana Hemophilia & Thrombosis Center | Indianapolis | Indiana | 46260 | United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| University of Medicine & Dentistry of New Jersey | New Brunswick | New Jersey | 08903-0019 | United States |
| Cornell Medical Center | New York | New York | 10021 | United States |
| Mt. Sinai Medical School | New York | New York | 10029 | United States |
| Children's Hospital Medical Center Pharmacy | Cincinnati | Ohio | 45229 | United States |
| Hemophilia Center of Western Pennsylvania | Pittsburgh | Pennsylvania | 15213-4306 | United States |
| Puget Sound Blood Center | Seattle | Washington | 98104-1256 | United States |
| Allgemeines Krankenhaus der Stadt Wien | Vienna | 1090 | Austria |
| KU Leuven Universitaire Ziekenhuizen | Leuven | 3000 | Belgium |
| University of Alberta | Calgary | Alberta | 470 MSB | Canada |
| Hôpital Edouard Herriot | Lyon | 69437 | France |
| Klinikum der J. W. Goethe - Universität | Frankfurt am Main | 60590 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30623 | Germany |
| Klinikum Innenstadt der Universität München | Munich | D-80336 | Germany |
| Ospedale Maggiore di Milano | Milan | 20122 | Italy |
| University Hospital MAS | Malmö | S-20502 | Sweden |
| The Royal Free Hospital | London | England | NW3 2QG | United Kingdom |
| Central Manchester Healthcare NHS Trust | Manchester | England | M13 9WL | United Kingdom |
| The Churchill Hospital | Oxford | England | OX3 7LJ | United Kingdom |
| University Hospital of Wales | Cardiff | Wales | CF4 4XW | United Kingdom |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
Not provided
Not provided