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Last Updated: May 8, 2021

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR TRANEXAMIC ACID

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505(b)(2) Clinical Trials for Tranexamic Acid

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
New Dosage NCT00588133 A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery Completed Mayo Clinic Phase 3 2004-01-01 Tranexamic acid is administered intravenously to prevent bleeding associated with cardiac surgery and cardiopulmonary bypass. We have developed an assay for tranexamic acid. We have developed an alternative dosing schedule for tranexamic acid. The objective of this preliminary study is to determine if this new dosing schedule can achieve the desired plasma concentration of tranexamic acid and reduce intra and inter patient variability in tranexamic acid plasma concentrations relative to the current dosing schedule.
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 Tranexamic Acid

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00111215 Treatment and Management of Women With Bleeding Disorders Completed Centers for Disease Control and Prevention N/A 2001-01-01 The purpose of the study is to determine whether oral contraceptives, desmopressin acetate, and/or tranexamic acid are effective in the treatment of women with menorrhagia who are diagnosed with a bleeding disorder.
NCT00147862 Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery? Completed Tata Memorial Hospital Phase 3 2005-05-01 To Study whether infusion of Tranexamic Acid (a synthetic antifibrinolytic agent) reduces blood loss during head and neck surgery.
NCT00279578 Clot Formation and Clot Stability in Patients With Severe Haemophilia A Completed University of Aarhus N/A 2006-01-01 In the present study we are examining the clot formation and clot stability in patients with severe haemophilia A after they receive recombinat factor VIII and after addition of tranexamic acid. Our hypothesis is that addition of tranexamic increases the clot stability. The perpective of the study is to document whether it is relevant to use traneksamic acid in surgery in patients with severe haemophilia A.
NCT00308880 Tranexamic Acid and Head and Neck Surgery Patients Unknown status Taichung Veterans General Hospital Phase 3 2006-03-01 Tranexamic acid belongs to fibrinolytic inhibitors. Several prospective randomized clinical trials have proved its effectiveness in reducing intra-operative and post-operative bleeding in orthopedic and cardiovascular surgeries. However, there is little study about tranexamic acid in reducing post-operative bleeding in head and neck surgery. So the aim of this study is to investigate if tranexamic acid could reduce post-operative bleeding via prospective double-blinded randomized clinic trial.
NCT00327106 Tranexamic Acid in HIp Fracture Surgery (THIF Study) Completed Centre Hospitalier Universitaire de Saint Etienne Phase 3 2005-04-01 The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.
NCT00355108 ATERO : A Randomised Study With Tranexamic Acid in Epistaxis of Rendu Osler Syndrome Completed Hospices Civils de Lyon Phase 3 2006-09-01 Scientific Objectives Primary objective : Demonstrate that oral intake of tranexamic acid significantly reduces the risk of epistaxis occurrence, estimated by the average monthly duration of episodes of epistaxis. Secondary objectives : - Document the benefit of tranexamic acid on the amount of haemoglobine and quality of life of patients. - Identify scalable and genetic factors of response to the treatment by tranexamic acid. - Describe compliance and tolerance of the treatment. Method Experimental Design We suggest the realisation of a randomised comparative clinical trial versus placebo, with a crossover of random alternated periods of three months over a total of six months. Study Population 213 affected patients, displaying sufficiently invalidating epistaxis to require a basal treatment, will be recruited and followed every 3 months. Recruitment will lean on teams who are part of the national French network in close collaboration with the reference centre for the Rendu-Osler disorder, appointed to Lyon on the 19th of November 2004. Follow up of the study will be carried out by the Clinical Investigational Centre of the related towns. Outcome measures The main criterion of efficacy is the average duration of epistaxis, the secondary criterion of efficacy is the average number of epistaxis measured per month. Tolerance will be analysed according to the occurrence of venal or arterial thrombosis and allergic accidents. Venal thrombosis will systematically be sought by an inferior limbs echodoppler. Response markers will be sought through modelisation incorporating environmental, phenotypic and genetic factors.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tranexamic Acid

Condition Name

Condition Name for Tranexamic Acid
Intervention Trials
Blood Loss 26
Tranexamic Acid 21
Hemorrhage 20
Postpartum Hemorrhage 19
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Condition MeSH

Condition MeSH for Tranexamic Acid
Intervention Trials
Hemorrhage 169
Postpartum Hemorrhage 38
Osteoarthritis 31
Blood Loss, Surgical 29
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Clinical Trial Locations for Tranexamic Acid

Trials by Country

Trials by Country for Tranexamic Acid
Location Trials
United States 161
Canada 45
Egypt 32
China 27
France 20
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Trials by US State

Trials by US State for Tranexamic Acid
Location Trials
New York 22
California 13
Pennsylvania 11
Illinois 9
Michigan 7
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Clinical Trial Progress for Tranexamic Acid

Clinical Trial Phase

Clinical Trial Phase for Tranexamic Acid
Clinical Trial Phase Trials
Phase 4 143
Phase 3 101
Phase 2/Phase 3 20
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Clinical Trial Status

Clinical Trial Status for Tranexamic Acid
Clinical Trial Phase Trials
Not yet recruiting 154
Recruiting 126
Completed 113
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Clinical Trial Sponsors for Tranexamic Acid

Sponsor Name

Sponsor Name for Tranexamic Acid
Sponsor Trials
Aswan University Hospital 17
Cairo University 12
Assiut University 11
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Sponsor Type

Sponsor Type for Tranexamic Acid
Sponsor Trials
Other 562
Industry 24
U.S. Fed 7
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