A blood collection in healthy adults and children aiming to see if apixaban, a new investigational anticoagulant (blood thinner) currently studied in adults, can also be used in children.
- Conditions
- ThrombosisMedDRA version: 17.0Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-003963-39-Outside-EU/EEA
- Lead Sponsor
- Bristol-Myers Squibb Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 81
* 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
* 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method