A Single Dose, Randomized, 2-Period Crossover Study in Patients with Hemophilia A to Evaluate the Pharmacokinetics of Refacto(B-domain deleted recombinant human factor VIII (BDDrFVIII) and Advate (a full-length recombinant factor VIII (FLrFVIII) - Refacto/Advate PK switch

Wyeth Pharmaceuticals, Global Medical Affairs0 个研究点目标入组 30 人开始时间: 2005年2月23日最近更新: 2012年5月1日

适应症

试验速览

暂无简介。

•Documented history of severe hemophilia A (FVIII:C =1%)·
•Previously treated patients (PTP) with at least 150 exposure days to any factor VIII product(s)
•Male aged =18 years and less than 65 years
•ALT and AST =5 x ULN, and bilirubin =2mg/dL
•Serum creatinine =1.25 x ULN
•Platelet count >100,000/µL
•Absolute CD4 count =200/mL
•Prothrombin time =1.25 x ULN
•Serum albumin = LLN
•Signed and dated informed consent
•Are the trial subjects under 18? no
•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) no
•F.1.3.1 Number of subjects for this age range

•Known hypersensitivity to any recombinant factor VIII product or murine/hamster allergen
•History of or current FVIII inhibitor, defined as = 0.6 BU or >ULN as defined at the local lab (whichever is lower).
•Surgery within 30 days prior to Period 1, Day 1 or surgery planned during the study
•The occurrence of a bleeding episode requiring FVIII replacement therapy within 3 days prior to Period 1, Day 1 (screening failure)
•Factor VIII treatment within 3 days (72 hours) prior to Period 1, Day 1 (screening failure) or Period 2, Day 1.
•Treatment with any investigational drug or device within the past 30 days with the exception of ReFacto, ReFacto AF or Advate.
•Patients who are currently on Highly Active Anti-Retroviral Therapy (HAART) are excluded.
•Unwillingness to agree to the washout period or other terms of the protocol
•The presence of any condition that, in the investigator’s opinion, makes participation in the study not advisable (eg, frequent bleeding episodes that preclude a subject from abiding by the 3-day washout, poor venous access resulting in the inability to provide adequate pharmacokinetic sampling)

发起方

Wyeth Pharmaceuticals, Global Medical Affairs