| Clinical efficacy and safety of the factor VIII/von Willebrand factor concentrate BIOSTATE in patients with von Willebrand's disease: a prospective multi-centre study. | |
| | |
MedLine Citation:
|
PMID: 20331755 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
von Willebrand's disease (VWD) is an inherited bleeding disorder characterized by deficient levels of or dysfunctional von Willebrand factor (VWF). This phase II/III open-label, multicentre study evaluated the efficacy and safety of BIOSTATE, a high purity plasma-derived double-virus inactivated FVIII/VWF concentrate, when used in non-surgical bleeds, surgical procedures and prophylactic therapy in VWD patients for whom desmopressin treatment was deemed ineffective, inadequate or contraindicated. Twenty three patients (7 type 1, 9 type 2 and 7 type 3; 12 male, 11 female), who received FVIII/VWF concentrate as part of their VWD management, were recruited prospectively between December 2004 and May 2007 from eight centres in Australia and New Zealand. BIOSTATE dosing was based on pre-treatment FVIII:C and/or VWF:RCo plasma levels and a predetermined dosing guide. Haemostatic efficacy of BIOSTATE was rated as excellent or good for all major and minor surgery events, long-term prophylaxis, and for four of the six assessable non-surgical bleeding events. Blood transfusions were required by two major surgery patients as well as one patient with a non-surgical bleed. The median overall exposure to BIOSTATE across all groups was 8 days, greater in the prophylactic group (range 53-197) compared with major surgery (3-24), minor surgery (1-8) and non-surgical bleeds (1-10). BIOSTATE was shown to be efficacious and well tolerated when treating patients with VWD. This study also provides important insights into dosing regimens with BIOSTATE and the role of monitoring therapy with FVIII:C and VWF:RCo. |
| | |
Authors:
|
S Dunkley; R I Baker; M Pidcock; J Price; M Seldon; M Smith; A Street; D Maher; G Barrese; C Stone; J Lloyd |
Related Documents
:
|
11002685 - Haemostasis with cryoprecipitate in patients undergoing surgery for severe von willebra... 20491745 - Natural history of acute colonic diverticular bleeding: a prospective study in 133 cons... 19035975 - Incidence of bleeding lesions within reach of conventional upper and lower endoscopes i... 22453625 - Botulinum toxin type a injection, followed by home-based functional training for upper ... 22327855 - Current status of postoperative follow-up for lung cancer in japan: questionnaire surve... 20940335 - Betahistine treatment improves the recovery of static symptoms in patients with unilate... |
Publication Detail:
|
Type: Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't Date: 2010-03-16 |
Journal Detail:
|
Title: Haemophilia : the official journal of the World Federation of Hemophilia Volume: 16 ISSN: 1365-2516 ISO Abbreviation: Haemophilia Publication Date: 2010 Jul |
Date Detail:
|
Created Date: 2010-07-20 Completed Date: 2011-01-05 Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 9442916 Medline TA: Haemophilia Country: England |
Other Details:
|
Languages: eng Pagination: 615-24 Citation Subset: IM |
Affiliation:
|
Haematology Dept, Royal Prince Alfred Hospital, Sydney, Newcastle, NSW, Australia. scott.dunkley@email.cs.nsw.gov.au |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Adolescent Adult Aged Aged, 80 and over Child Child, Preschool Drug Administration Schedule Drug Combinations Factor VIII / administration & dosage, analysis, therapeutic use* Female Hemorrhage / prevention & control Hemostasis / drug effects Humans Male Middle Aged Prospective Studies Virus Inactivation Young Adult von Willebrand Diseases / drug therapy* von Willebrand Factor / administration & dosage, analysis, therapeutic use* |
| Chemical | |
Reg. No./Substance:
|
0/Drug Combinations; 0/von Willebrand Factor; 9001-27-8/Factor VIII |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: The prevalence of factor VIII inhibitors and genetic aspects of inhibitor development in Chinese pat...
Next Document: Balance dysfunction in adults with haemophilia.