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Last Updated: November 23, 2020

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CLINICAL TRIALS PROFILE FOR APIXABAN

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505(b)(2) Clinical Trials for Apixaban

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT04550338 Antiviral Effects of TXA as a Preventative Treatment Following COVID-19 Exposure Not yet recruiting University of Alabama at Birmingham Phase 3 2020-12-01 A recent report in Physiolological Reviews proposed that the endogenous protease plasmin acts on SARS-CoV-2 by cleaving a newly inserted furin site in the S protein portion of the virus resulting in increased infectivity and virulence. A logical treatment that might blunt this process would be the inhibition of the conversion of plasminogen to plasmin. Fortunately, there is an inexpensive, commonly used drug, tranexamic acid, TXA, which suppresses this conversion and could be re-purposed for the treatment of COVID-19. TXA is a synthetic analog of the amino acid lysine which reversibly binds four to five lysine receptor sites on plasminogen. This reduces conversion of plasminogen to plasmin, and is normally used to prevent fibrin degradation. TXA is FDA approved for the outpatient treatment of heavy menstrual bleeding (typical dose 1300 mg p.o. TID x 5 days) and off-label use for many other indications. TXA is used perioperatively as a standard-of-care at UAB for orthopedic and cardiac bypass surgeries. It has a long track record of safety such that it is used over-the-counter in other countries as an antiviral and for the treatment of cosmetic dermatological disorders. Given the potential benefit and limited toxicity of TXA it would appear warranted to perform randomized, double-blind placebo controlled exploratory trial at UAB as a prophylactic antiviral treatment following exposure to COVID-19 in order to determine whether it reduces infectivity and virulence of the SARS-CoV-2 virus as hypothesized. Involvement of each patient is only for 7 days before primary endpoints and 30 days for final data collection.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Apixaban

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00097357 BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery Completed Bristol-Myers Squibb Phase 2/Phase 3 2004-10-01 The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied.
NCT00252005 Oral Direct Factor Xa-inhibitor Apixaban in Patients With Acute Symptomatic Deep-vein Thrombosis-The Botticelli DVT Study Completed Bristol-Myers Squibb Phase 2 2005-11-01 The purpose of this clinical research study is to assess efficacy and safety of 3 doses of apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the treatment of subjects with acute symptomatic deep-vein thrombosis.
NCT00313300 Safety Study of Apixaban in Recent Acute Coronary Syndrome Completed Bristol-Myers Squibb Phase 2 2006-05-01 The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.
NCT00320255 A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer Completed Ontario Clinical Oncology Group (OCOG) Phase 2 2006-06-01 The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.
NCT00320255 A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer Completed Bristol-Myers Squibb Phase 2 2006-06-01 The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Apixaban

Condition Name

Condition Name for Apixaban
Intervention Trials
Atrial Fibrillation 36
Venous Thromboembolism 27
Pulmonary Embolism 15
Deep Vein Thrombosis 12
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Condition MeSH

Condition MeSH for Apixaban
Intervention Trials
Atrial Fibrillation 52
Thromboembolism 33
Thrombosis 32
Venous Thromboembolism 29
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Clinical Trial Locations for Apixaban

Trials by Country

Trials by Country for Apixaban
Location Trials
United States 565
United Kingdom 116
Canada 112
Mexico 93
Japan 80
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Trials by US State

Trials by US State for Apixaban
Location Trials
California 27
Texas 25
Pennsylvania 24
Florida 22
North Carolina 21
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Clinical Trial Progress for Apixaban

Clinical Trial Phase

Clinical Trial Phase for Apixaban
Clinical Trial Phase Trials
Phase 4 40
Phase 3 43
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Apixaban
Clinical Trial Phase Trials
Recruiting 63
Not yet recruiting 50
Completed 35
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Clinical Trial Sponsors for Apixaban

Sponsor Name

Sponsor Name for Apixaban
Sponsor Trials
Bristol-Myers Squibb 73
Pfizer 29
Assistance Publique - Hôpitaux de Paris 5
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Sponsor Type

Sponsor Type for Apixaban
Sponsor Trials
Other 162
Industry 119
NIH 5
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