Reformulated BeneFIX efficacy and safety after conversion from a pdFIX.

Wyeth Pharmaceuticals France0 个研究点目标入组 20 人开始时间: 2007年12月17日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•· Moderately to severe hemophilia B patient (FIX activity =< 2%) for whom the switch from pdFIX to BeneFIX has already been decided by the investigator
•· Previously treated patients (PTP) with >= 150 ED to any FIX product
•· Male patients, aged >= 12 years
•· Absolute CD4 count >= 300/ml
•· Normal platelet count (>= 100 000/ml)
•· Patient is in a non-bleeding state and has not received any coagulation FIX within five (5) days of recovery
•· Written informed consent obtained prior to study entry (for patients aged < 18 years, parents’ signature or subject legally acceptable representative obtained prior to study entry).
•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

•· Any other known bleeding disorder in addition to hemophilia B
•· History of, or current detectable factor IX inhibitor (>= 0.6 BU by Bethesda inhibitor assay)
•· History of anaphylaxis to any coagulation factor IX
•· Patient with a known hypersensitivity to hamster protein
•· Patient unable to be off FIX replacement therapy for at least 5 days without bleeding
•· Patient with hepatic or renal impairment (ALT [SGPT] and AST [SGOT] > 5 x Upper Limit Normal (ULN), total bilirubin > 20mg/l, albumin < 25 g/l, prothrombin time >1.25 x ULN, serum creatinine > 1.25 x ULN)
•· Treatment with any investigational drug or device within the past 30 days
•· Any condition that, in the Investigator’s judgement, makes participation in the study not advisable.

发起方

Wyeth Pharmaceuticals France