EUCTR2015-003027-61-Outside-EU/EEA进行中（未招募）不适用
An open-label, single dose pharmacokinetic study of BeneFIX (nonacog alfa, recombinant factor IX) in male Chinese subjects with haemophilia B.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 12
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
- •Subjects must meet all of the following criteria;
- •Male Chinese subjects 6 years and older (weight =20 kg) with moderate to severe hemophilia B (Factor IX activity =2%)
- •Subjects should not have received infusion of any Factor IX products for at least 4 days before the administration of BeneFIX on Day 1
- •Subjects must be in a non-bleeding state before BeneFIX administration on Day 1
- •Evidence of personally or legally representative (legal only for pediatric subjects) signed and dated informed consent documentation indicating that the subject has been informed of all pertinent aspects of the study
- •Subjects who are willing and able to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Subjects presenting with any of the following will not be included in the study
- •Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic (including drug allergies) disease or clinical findings at Screening.
- •Diagnosed with any other bleeding disorder in addition to Haemophilia B
- •Documented Human Immunodeficiency Virus positive patients
- •Current FIX inhibitor or history of FIX inhibitor (defined as =Upper Limit of Normal (ULN) of the reporting lab)
- •Subjects anticipating elective surgery that may be planned to occur in the 1 month following study entry
- •Treated with immunomodulatory therapy within 30 days
- •Treated with an investigational drug within 30 days or 5 half-lives preceding the first dose of the study drug
- •Subjects with known hypersensitivity to the active substance or to any of the excipients of BeneFIX
- •Subjects with known hypersensitivity to Chinese Hamster Ovary cell (CHO cell) proteins
- •Subjects with any of hepatic or renal impairment (ALT or AST >3x Upper Limit of Normal (ULN), total bilirubin >2x ULN, serum creatinine >2x ULN), Prothrombin Time >1.5x ULN, Platelet count <80,000 uL
- •Unwilling or unable to follow the terms of the protocol
- •Any condition which may compromise the subject’s ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor
- •A positive urine drug screen
- •History of regular alcohol consumption exceeding 14 drinks/week for men within 6 months of screening
- •Screening supine blood pressure =140 mm Hg (systolic) or =90 mm Hg (diastolic) following at least 5 minutes rest
- •12-lead ECG showing QTc >450 msec or QRS >120 msec at screening
- •Blood donation of approximately 1 pint within 56 days prior to dosing
- •History of sensitivity to heparin or heparin-induced thrombocytopenia
- •Unwilling or unable to comply with the Lifestyle Guidelines
- •Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase risk associated with study participation.
研究者
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