Multicentre, Non-controlled, Prospective, Post-Marketing Safety Study Following Long-Term Prophylactic Optivate® Treatment in Subjects with Severe Haemophilia A. - Post Marketing study following long term prophylactic Optivate usage

Bio Products Laboratory Limited0 个研究点目标入组 7 人2016年1月20日

概览

暂无简介。

注册库

who.int

开始日期

2016年1月20日

结束日期

2017年8月31日

最后更新

6年前

研究类型

Interventional clinical trial of medicinal product

发起方

•\- Written informed consent or, in the case of children and adolescents (less than 18 years of age) have given written assent (where possible) and whose parent/guardian has given written informed consent.
•\- Severe haemophilia A (\< 1% FVIII:C). Subjects suffering from severe haemophilia A
•(\< 2%) may be enrolled, but only after approval by BPL. Subjects with a FVII
•\< 2% may not constitute more than 50% of the total patient population. A separate
•statistical evaluation will be conducted for the \< 1% and \< 2% populations. Basal
•FVIII level taken from subject’s lowest level recorded, or the level measured at screening, whichever is lower.
•\- Previously Treated Patients (PTPs) with \> 150 exposure days on prior FVIII therapy (of
•which at least the last 50 EDs or 2 years treatment can be confirmed by way of subject
•\- Immunocompetent subjects with CD4 (cluster differentiation 4\) count \> 200 /µL.
•\- Human Immunodeficiency Virus (HIV) negative subjects or a viral load \< 200 particles

•\- History of inhibitor development to FVIII or a positive result on the Nijmegen\-Bethesda at screening (quantitative result of \> 0\.6 Bethesda Units \[BU]) prior to the administration of Optivate®.
•\- Known or suspected hypersensitivity to the Investigational Medicinal Product (IMP) or its excipients.
•\- Clinically significant i.e. symptomatic liver disease and/or (historical, within the last 12 months, serum Alanine Aminotransferase \[ALT] levels greater than three times the
•upper limit of the normal range), symptomatic renal disease and/or (historical, within the last 12 months, serum creatinine \> 200?mol/L), or coagulopathy other than haemophilia A.
•\- History of unreliability or non\-cooperation (including not being able to complete the study diary).
•\- Participating in, or have taken part in another trial within the last 30 days.