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 12 人开始时间: 2016年6月29日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•- 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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 2
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 9
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•- 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.

发起方