Status:
COMPLETED
Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Bristol-Myers Squibb
CSL Behring
Conditions:
Thrombosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Apixaban is an anticoagulant (also known as blood thinner) approved by the Food and Drug Administration (FDA) for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial...
Detailed Description
Oral anticoagulants are effective in the treatment and prevention of venous and arterial thrombotic events. For more than 50 years the only class of anticoagulant available had been the vitamin K anta...
Eligibility Criteria
Inclusion
- In order to be eligible for participation in this trial, the subject must:
- Be a healthy male or female between ages 18-55 (inclusive) at the screening visit
- Have a body mass index (BMI) \>19 and \<33 (inclusive)
- If a female, subject
- Can be of childbearing potential and must demonstrate a urine β-hCG level consistent with the nongravid state at the pretrial (screening) visit and agree to use (and/or have their partner use) an acceptable method of birth control beginning at the pretrial visit throughout the trial (including washout intervals between treatment periods) and until 2 weeks after the last dose of trial drug in the last treatment period.
- Can be of non-childbearing potential which is defined as: a female who is postmenopausal without menses for at least 1 year and an Follicle stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation and/or a female who is status post hysterectomy, oophorectomy or tubal ligation
- Must be off hormonal oral or transdermal contraceptives for at least 4 weeks prior to initial dose of trial drug
- Be a nonsmoker for at least approximately 6 months
- Have serum creatinine level \< 1.5 mg/dL
- Have a prothrombin time (PT) and activated partial thromboplastin time (PTT) level below the upper limit of normal
- Have platelet count within normal limits
- Be willing to refrain from the use of anticoagulants and antiplatelet medications including aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) during the entire period of study participation
- Be willing to provide written informed consent for the trial
- Be willing to comply with trial restrictions
Exclusion
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has history of cancer (excluding treated cutaneous squamous or basal cell carcinoma of \>3 years previous)
- Has history of venous or arterial thromboembolic disease
- Has a history of clinically significant bleeding risks including prior serious head trauma
- Has had major surgery within 6 months prior to screening visit
- Is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies for 2 weeks prior to trial start date until the post-trial visit
- Is unable to refrain from using any drugs or substance known to be inhibitors or inducers of cytochrome P450 (CYP) enzymes including grapefruit products for 2 weeks prior to dosing and throughout the study, until the post-trial visit
- Has a history of illicit drug abuse within six months prior to screening visit
- Consumes greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[354 mL/12 ounces\], wine \[118 mL/4 ounces\], or distilled spirits \[29.5 mL/1 ounce\]) per day and cannot refrain from alcohol for the duration of the trial
- Has a history of significant multiple and/or severe allergies (e.g. food, drug), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
- Has known anaphylactic or severe systemic reactions to any components of study drugs (including heparin induced thrombocytopenia) or contraindication to the administration of PCC or any other related blood products.
- Has moderate or severe hepatic disease or other clinically relevant bleeding risk
- Has positive history for hepatitis B surface antigen, hepatitis C or HIV
- Has first degree relatives with history of bleeding disorder or hypercoagulable disease
- Use of any drugs or products which at the discretion of the investigator would increase bleeding risk
- Is considered inappropriate for participation by the investigator for any reason
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02270918
Start Date
November 1 2014
End Date
December 1 2014
Last Update
June 7 2016
Active Locations (1)
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1
Thomas Jefferson University Hosptial
Philadelphia, Pennsylvania, United States, 19107