EUCTR2008-007347-13-BG进行中（未招募）不适用
Advate (rAHF-PFM): Pharmacokinetic comparison of 3000 IU Advate (rAHF-PFM) (using one 3000 IU potency vial) with 3000 IU Advate (rAHF-PFM) (using two 1500 IU potency vials) in previously treated patients with severe hemophilia A: a Phase IV, open-label, prospective, randomized, controlled, crossover, multiple center study - Advate 3000
适应症
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
- 23
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
- Male
入选标准
- •1. Subject is male 18 to 65 years old, at the time of screening.
- •2. The subject has provided signed informed consent.
- •3. The subject has severe hemophilia A, defined by a baseline FVIII level < 1% of normal (based on the chromogenic and the one stage activated partial thromboplastin time (aPTT) assays), as tested at screening at the central laboratory.
- •4. The subject's weight is between 55-65 kg.
- •5. The subject was previously treated with FVIII concentrate(s) for a minimum of 150 exposure days (as estimated by the investigator) prior to study entry.
- •6. If this subject is human immunodeficiency virus (HIV) positive, he must be immunocompetent as determined with a CD4 count >/= 200 cells/mm3 (CD4 count at screening).
- •7. Subject is willing and able to comply with the requirements of the protocol.
- •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
排除标准
- •1. The subject has a detectable FVIII inhibitor at screening, with a titer >/= 0.4 BU (Nijmegen modification of the Bethesda Assay) measured at the central laboratory.
- •2. The subject has a history of FVIII inhibitors with a titer >/= 0.4 BU (by Nijmegen assay) or >/= 0.5 BU (by Bethesda Assay) at any time prior to screening.
- •3. The subject has undergone a surgery within 21 days prior to screening or within 6 weeks prior to the anticipated first PK infusion.
- •4. The subject has an abnormal renal function (serum creatinine >1.5 mg/dL).
- •5. The subject has active hepatic disease (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 5 times the upper limit of normal).
- •6. The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized RAtio (INR) > 1.4, as hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly, and history of esophageal varices.
- •7. The subject has clinical and/or laboratory evidence of abnormal hemostasis from causes other than hemophilia A (ed, late-stage chronic liver disease, or immune thrombocytopenia purpura).
- •8. The subject is currently receiving, or is scheduled to receive during the course of the study, an immunomodulating drug other than anti-retroviral chemotherapy (eg, alpha-interferon, or corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day).
- •9. The subject has a known hypersensitivity to mouse or hamster proteins.
- •10. Subject has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
- •11. The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures.
- •12. The subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, or parents) as well as employees of the investigator or site personnel conducting the clinical study.
研究者
相似试验
进行中（未招募）
不适用
PHARMACOKINETIC COMPARISON OF ADVATE rAHF-PFM WITH RECOMBINATE rAHF IN PATIENTS WITH SEVERE HEMOPHILIA A: A PHASE IV, PROSPECTIVE, RANDOMIZED, CONTROLLED, CROSS-OVER, SINGLE CENTER STUDY - Advate rAHF-PFM versus Recombinate rAHFEUCTR2007-004834-18-DEBaxter Innovations GmbH
已完成
4 期
Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia AHemophilia ANCT00666406Baxalta now part of Shire9
已完成
4 期
Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia AHemophilia ANCT00916032Baxalta now part of Shire29
尚未招募
2 期
A Comparative Study of Three Urolithin A FormulationsCTRI/2024/04/065369Amazentis SA
已完成
不适用
Comparison of the effects of different doses of Atorvastatin on blood homocysteine levels in male Patients with heart disease.Ischemic Heart Disease.Acute myocardial infarctionIRCT2013071614018N1Mazandaran University of Medical Sciences52