Phase 3 Clinical Trial: Perioperative Use of Nonacog Gamma, a Recombinant Factor IX, in Previously Treated Patients With Moderate/Severe Hemophilia B.
Clin Appl Thromb Hemost
; 26: 1076029620946839, 2020.
Article
en En
| MEDLINE
| ID: mdl-32816519
ABSTRACT
Hemostatic management is essential for ensuring the safety of patients with hemophilia during surgery. This phase 3, prospective, uncontrolled trial, evaluated hemostatic efficacy, consumption, and safety of a recombinant factor IX concentrate, nonacog gamma (BAX 326, Rixubis® [Baxalta US Inc., a Takeda company, Lexington, MA, USA]), in intraoperative and postoperative settings in previously treated patients (PTPs) with severe or moderately severe hemophilia B undergoing elective surgery (N = 38 surgeries; 21 major, 17 minor). Predefined preoperative hemostatic factor IX levels (80-100% of normal for major and 30-60% for minor surgeries) were maintained for each patient. Intraoperative efficacy was rated as "excellent" or "good" for all surgeries. Postoperative hemostatic efficacy on day of discharge was rated as "excellent," "good," and "fair," respectively, for 29 (76.3%), 7 (18.4%), and 2 (5.3%) surgical procedures. All adverse events were considered unrelated to study drug; most frequently reported was mild procedural pain (9 patients). No thrombotic events, severe allergic reactions, or inhibitor formation were observed. Nonacog gamma was well tolerated and effective for intraoperative and postoperative hemostatic management of PTPs with hemophilia B.NCT01507896, EudraCT 2011-000413-39.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Factor IX
/
Hemofilia B
Tipo de estudio:
Clinical_trials
/
Observational_studies
Límite:
Adolescent
/
Adult
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Aged
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Child
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Female
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Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Clin Appl Thromb Hemost
Asunto de la revista:
ANGIOLOGIA
Año:
2020
Tipo del documento:
Article
País de afiliación:
Polonia