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Thromb Haemost 1996; 75(01): 030-035
DOI: 10.1055/s-0038-1650217
Original Article
Schattauer GmbH Stuttgart

Safety and Efficacy of Monoclonal Antibody Purified Factor IX Concentrate in Previously Untreated Patients with Hemophilia B

Amy D Shapiro
1   The Riley Hospital for Children, Indiana University Medical Center, Indianapolis, IN, USA
,
Margaret V Ragni
2   The University of Pittsburgh School of Medicine and Hemophilia Center of Western Pennsylvania, Pittsburgh, PA, USA
,
Jeanne M Lusher
3   The Children's Hospital of Michigan, Detroit, MI, USA
,
Steven Culbert
4   The Gulf States Hemophilia Center, Houston, TX, USA
,
Marion A Koerper
5   The University of California, San Francisco, CA, USA
,
Garrett E Bergman
6   The Department of Medical and Scientific Affairs, Armour Pharmaceutical Company, Collegeville, PA, USA
,
Margaret M Hannan
6   The Department of Medical and Scientific Affairs, Armour Pharmaceutical Company, Collegeville, PA, USA
› Author Affiliations
Further Information

Publication History

Received 28 April 1995

Accepted after resubmission 28 September 1995

Publication Date:
10 July 2018 (online)

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Summary

The safety and efficacy of a monoclonal antibody purified factor IX concentrate were evaluated in two continuing trials of 32 previously untreated patients with mild, moderate, or severe hemophilia B. Patients were evaluated every 2 weeks for 24 weeks and every 3 months thereafter for at least 1 year. No patients became positive for human immunodeficiency virus antibody or hepatitis C virus antibody during the trial. Two patients developed a false-positive hepatitis B core antibody, one transiently, but neither had elevated levels of alanine aminotransferase (ALT). None of the 25 patients evaluable for non-A, non-B, non-C hepatitis by strict International Society of Thrombosis and Hemostasis criteria developed elevated levels of ALT indicative of posttransfusion infection. Anaphylaxis occurred in one subject who also developed an inhibitor to factor IX (19.3 Bethesda units). Five of the eight adverse events reported (63%) were mild in severity, and the relationship of three of these to therapy was considered remote. Hemostasis with monoclonal antibody purified factor IX concentrate was excellent in all patients.

 

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