Linked Life Data

21299747

Source:http://linkedlifedata.com/resource/pubmed/id/21299747

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
2011-6-22
pubmed:abstractText
Effective treatment with factor IX (FIX) requires a thorough consideration of the properties of the concentrate to be used as replacement therapy, to date, the only available treatment for haemophilia B. The aim of the study was to determine the pharmacokinetics, clinical efficacy and safety in routine clinical use of AlphaNine(®) , a high-purity human FIX concentrate. This open, single-arm, multicentre, non-randomized trial included 25 subjects (age ? 12) with moderate/severe haemophilia B. Pharmacokinetics was assessed at baseline and after a 6-month follow-up. The degree of haemostasis control achieved was evaluated during a 12-month follow-up. Safety was evaluated in terms of tolerance, thrombogenicity, immunogenicity and viral safety. Mean recovery was 1.01 ± 0.19?IU?dL(-1) per IU?kg(-1) at baseline and 1.23 ± 0.34 IU dL(-1) per IU?kg(-1) 6?months later. Terminal half-life was 34.5 ± 6.2 h and 33.7 ±?5.4?h, respectively. Ratios of each parameter between the two pharmacokinetic studies were all close to 1. A total of 1,576,890?IU AlphaNine(®) were administered in 889 infusions (mean dose per infusion: 1774 IU; 3.2 infusions per month per patient). The main reasons for infusion were mild/moderate bleeding (62.3%) and prophylaxis (20.5% continuous, 15.6% intermittent). Overall, 93.0% of the efficacy assessments were rated as excellent/good and 88.8% of bleedings resolved after the first infusion. Twenty-one adverse events were reported in eight patients, none of which was considered related to the study medication. AlphaNine(®) showed a pharmacokinetic profile in agreement with that of other plasma-derived FIX concentrates and provides safe and clinically effective substitution therapy for patients with haemophilia B.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jul
pubmed:issn
1365-2516
pubmed:author
pubmed:copyrightInfo
© 2011 Blackwell Publishing Ltd.
pubmed:issnType
Electronic
pubmed:volume
17
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
590-6
pubmed:meshHeading
pubmed:year
2011
pubmed:articleTitle
A clinical study assessing the pharmacokinetics, efficacy and safety of AlphaNine(®) , a high-purity factor IX concentrate, in patients with severe haemophilia B.
pubmed:affiliation
National Center of Hematology, Sofia, Bulgaria. t.lissitchkov@yahoo.com
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't, Multicenter Study