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

BIO PRODUCTS LABORATORY LIMITED (BPL)0 个研究点目标入组 13 人开始时间: 2014年4月7日最近更新: 2017年2月20日

适应症

试验速览

暂无简介。

•Written informed consent or, if less than 18 years of age written assent (where possible) and their parent/guardian’s 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 Factor VIII of < 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 Factor VIII therapy (of which at least the last 50 EDs or 2 years treatment can be confirmed by way of subject records).
•Immunocompetent with CD4 count > 200 /µL.
•HIV negative or a viral load < 200 particles /µL.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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 liver disease (serum Alanine Aminotransferase [ALT] levels greater than three times the upper limit of the normal range), renal disease (serum creatinine > 200mol/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

BIO PRODUCTS LABORATORY LIMITED (BPL)