EUCTR2014-003963-39-Outside-EU/EEA进行中（未招募）不适用
An In Vitro Comparison of Apixaban Activity in Adult and Pediatric Plasma
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
- 81
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
- •* For healthy adult subjects:
- •- signed informed consent form
- •- Male or female subjects as determined by no clinically significant deviation from normal in medical history and physical examination
- •- ages 18 to 45
- •* For pediatric patients:
- •- Parent or legally acceptable representatives must sign informed consent form for all subjects < 18 years old. Assent should be obtained when the minor is judged to be of an age of reason (see protocol Appendix 1).
- •- signed informed consent form from the mother donating the umbilical cord blood.
- •- Male and female subjects as determined by no clinically significant findings in medical history or physical examination that would prevent the subjects from donating 1-9 mL of blood.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 70
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •* For healthy adult subjects:
- •(1) Medical History and Concurrent Diseases
- •a) Any significant acute or chronic medical illness.
- •b) Any major surgery within 4 weeks of enrollment
- •c) History or evidence of abnormal bleeding or coagulation disorder and/or having a first degree relative coagulation disorder due to genetic defects.
- •d) Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study enrollment.
- •e) Blood transfusion within 4 weeks of study enrollment.
- •f) Inability to be phlebotomized and/or tolerate venous access.
- •g) Recent (within 6 months) drug or alcohol abuse
- •h) Any other sound medical, psychiatric and/or social reason as determined by the investigator.
- •i) Smoking more than 10 cigarettes per day.
- •j) History of positive urine screen for drugs of abuse in the past 6 months.
- •k) PMH of positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV viral RNA or HIV-1, -2 antibody.
- •(2) Physical Findings
- •a) Evidence of excessive bruising, petechia, or organ dysfunction or clinically significant findings that would prevent donation of blood.
- •(3) Prohibited Treatments and/or Therapies
- •a) Exposure to any investigational drug or placebo within 4 weeks of enrollment.
- •b) Use of any other drugs, including over-the-counter medications and herbal preparations, within 1 week prior to study enrollment.
- •c) Currently or within 14 days of blood draw taking any anticoagulants, and thrombolytics
- •(4) Other Exclusion Criteria
- •Prisoners or subjects who are involuntarily incarcerated; Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
- •* For pediatric patients:
- •(1) Medical History and Concurrent Diseases
- •a) Any significant acute medical illness or a chronic medical illness of leukemia, lymphoma, hepatic impairment, significant renal impairment or severe anemia.
- •b) Subjects known to have prolongation of PT or PTT.
- •c) History of positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV viral RNA or HIV-1, -2 antibody. Pediatric subjects born to HIV, hepatitis B, hepatitis C positive mothers may be included into the study
- •if they test positive on an antibody test, but they are confirmed not HIV, HCV, or HBV infected after been tested according to standard of care guidelines.
- •d) Subjects with cancer on any therapy or subjects in remission treated with chemotherapy < 3 months ago.
- •e) Subjects with known genetic disorders such as hemophilia or thrombophilia or other factor deficiencies.
- •f) History or evidence of abnormal bleeding or coagulation disorder and/or having a first degree relative coagulation disorder due to genetic defects.
- •g) Any major surgery within 4 weeks of study enrollment
- •h) Blood transfusion within 4 weeks of study enrollment.
- •i) Twenty-four hour blood volume loss = 3% of subject’s estimated blood volume.
- •j) Inability to be phlebotomized and/or tolerate venous access.
- •k) Recent (within 6 months) drug or alcohol abuse
- •l) Any other medical, psychiatric and/or social reason as determined by the investigator.
- •m) Smoking more than 10 cigarettes per day.
- •n) History of a significant complicated pregnancy as determined by PI or designee (for women donating umbilical cord blood).
- •o) Pediatric subjects <1 year of age with maternal history of lupus anticoagulant, ITP, or other acquired coagulopathy.
- •(2) Physical Findings
- •a) Evidence of excessive bruising, pet
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