EUCTR2005-005697-71-PL进行中（未招募）不适用
Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method (rAHF PFM): A Phase 3/4, Prospective, Controlled, Randomized, Multi-Center Study to Compare the Efficacy and Safety of Continuous Infusion (CI) versus Intermittent Bolus Infusion (BI) in Subjects with Severe or Moderately Severe Hemophilia A Undergoing Major Orthopedic Surgery - Advate Randomized Surgery
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.The subject or the subject’s legally authorized representative has provided signed informed consent.
- •2.The subject is within 18 to 70 years of age.
- •3.The subject has severe or moderately severe hemophilia A, defined by a baseline FVIII level = 2% of normal, as tested at screening. A subset of 15 subjects per group must have baseline FVIII levels < 1% of normal.
- •4.The aPTT must be within the range of normal after administration of FVIII concentrate, as determined in the preoperative pharmacokinetic evaluation, or as documented in the medical history, if available.
- •5.The subject is scheduled to undergo an elective unilateral major orthopedic surgery that requires drain replacement.
- •6.The subject was previously treated with FVIII concentrate(s) for a minimum of at least 150 exposure days prior to study entry.
- •7.Human immunodeficiency virus (HIV) positive subjects must be immunocompetent as determined with a CD4 count = 200 cells/mm³ (CD4 count at screening), but HIV negative subjects with a CD count < 200 cells/mm³ qualify, if immunocompetency is documented.
- •8.The subject has a life expectancy of at least 28 days from the day of surgery.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. The subject has a detectable FVIII inhibitor at screening, with a titer = 0.4BU (Nijmegen modification of the Bethesda Assay) in the central laboratory.
- •2.The subject has a history of FVIII inhibitors with a titer = 0.4BU (by
- •Nijmegen assay) or = 0.5 BU (by Bethesda assay) at any time prior to
- •3.The subject is scheduled to undergo any other concurrent minor or
- •major surgery during the course of the study. The placement of central venous lines and the performance of fine needle aspiration biopsies are permitted.
- •4. Excluding hemophilia-related physical impairments, the subject is
- •assigned to NYHA class = III according to the New York Heart Association (NYHA).
- •5.The subject has an abnormal renal function (serum creatinine > 1.5
- •6.The subject has active hepatic disease (alanine aminotransferase
- •[ALT] or aspartate aminotransferase [AST] levels > 5 times the upper
- •limit of normal).
- •7.The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
- •8.The subject has clinical and/or laboratory evidence of abnormal
- •hemostasis from causes other than hemophilia A (e.g., late-stage chronic liver disease, immune thrombocytopenic purpura).
- •9.The subject is currently receiving, or is scheduled to receive during the course of the study, an immunomodulating drug other than antiretroviral chemotherapy (e.g., a-interferon, corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day).
- •10.The subject has a known hypersensitivity to mouse or hamster
- •11.The subject has received another investigational drug within 30 days prior to screening and/or is scheduled to receive additional
- •investigational drug during the course of the trial in the context of
- •another investigational drug study.
- •12.The subject is identified by the investigator as being unable or
- •unwilling to cooperate with study procedures.
研究者
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