EUCTR2015-003685-88-Outside-EU/EEA进行中（未招募）不适用
An Open-label, Single Dose Pharmacokinetic Study Of Xyntha (moroctocog Alfa (af-cc), Recombinant Factor VIII) In Male Chinese Subjects With Hemophilia A
适应症
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
- 13
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. Male Chinese subjects 6 years or older (weight >20kg) with severe hemophilia A (factory VIII activity <1%) previously treated with >150 exposure days to any FVIII-containing products
- •2. Subjects should not have received an infusion of any FVIII products for at least 3 days (at least 72 hours) before the administration of Xyntha on Day 1
- •3. Subjects must be in a non-bleeding state before the administration of Xyntha on Day 1
- •4. Evidence of a personally or legally acceptable representative (legally acceptable representative is only applicable to pediatric subjects) signed and dated informed consent document indicating that the subject or legally acceptable representative has been informed of all pertinent aspects of this study.
- •5. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 13
- •F.1.2 Adults (18-64 years) no
- •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. Current FVIII inhibitor or history of FVIII inhibitor (defined as > upper limit of normal (ULN) of the local reporting laboratory).
- •2. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at Screening.
- •3. Diagnosed with any other bleeding disorder in addition to hemophilia A.
- •4. Documented Human Immunodeficiency Virus (HIV).
- •5. Subjects anticipating elective surgery or other invasive procedure within 1 month following study entry.
- •6. Treatment with immunomodulatory therapy within 30 days or 5 half-lives whichever is longer, prior to study entry or planned use for the duration of study participation.
- •7. Subjects with known hypersensitivity to the active substance or to any of the excipients of Xyntha.
- •8. Subjects with a known hypersensitivity to Chinese Hamster Ovary cell (CHO cell) proteins.
- •9. Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary: significant hepatic or renal impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x ULN, or total bilirubin >2 x ULN or serum creatinine >2 x ULN), prothrombin time >1.5 x ULN, platelet count <80,000 ?L. Subjects with Gilbert’s disease may be enrolled.
- •10. 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.
- •11. A positive urine drug screen.
- •12. History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces (150 mL) of wine, 12 ounces (360 mL) of beer, or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- •13. Treatment with an investigational drug within 30 days or 5 half-lives preceding Day 1, whichever is longer.
- •14. Screening supine BP =140 mm Hg (systolic) or =90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is =140 mm Hg (systolic) or =90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject’s eligibility.
- •15. Screening supine 12-lead ECG demonstrating QTcF >450 or a QRS interval >120 msec. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTcF or QRS values should be used to determine the subject’s eligibility.
- •16. Blood donation (excluding plasma donations) of approximately 500 mL or more within 56 days prior to dosing.
- •17. History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •18. Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
- •19. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
- •20. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of stud
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