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Last Updated: October 2, 2023


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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OTC NCT04550338 ↗ Antiviral Effects of TXA as a Preventative Treatment Following COVID-19 Exposure Withdrawn University of Alabama at Birmingham Phase 3 2021-08-01 A recent report in Physiolological Reviews proposed that the endogenous protease plasmin acts on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.
New Dosage NCT05075200 ↗ Tranexamic Acid Dosing for Major Joint Replacement Surgery Not yet recruiting Sunnybrook Health Sciences Centre Phase 2 2021-10-01 Over 1.7 million hip and knee replacements are performed every year worldwide. These surgeries are associated with high blood loss and transfusion rates. In older patients, the high blood loss can result in postoperative anemia. Anemia is a condition where there is a lack of healthy red blood cells to carry oxygen around the body. This means, the patient may need a blood transfusion. This can result in different immune responses such as lung injury, fluid overload, and sepsis. The purpose of this study is to find an optimal dose of tranexamic acid (TXA) to be given during a hip or knee replacement surgery. TXA is one of the drugs given during surgery because it lowers the amount of bleeding and the risk of a blood transfusion. Individuals who are chosen to participate in the study will be split into two separate groups. After anesthesia is administered, study participant will be given the hospitals standard dose of TXA which is 20mg/kg. However, in patients with kidney problems and lower kidney functions, the dose will be lowered because TXA is filtered out of the body through the kidneys. Throughout the surgery and after it, patients will have about 30-50mL (3-5 tablespoons) of blood samples drawn at specific time points. This will be done through IV line which will stay in place during the surgery and post operation to minimize the amount of needle puncturing's. This study will help to development a new dosing guideline for TXA in patients who are undergoing joint replacement surgery.
>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.
NCT00375258 ↗ Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage Completed London School of Hygiene and Tropical Medicine Phase 3 2005-05-01 CRASH 2 is a large pragmatic randomised placebo controlled trial of the effects of the early administration of the antifibrinolytic agent tranexamic acid on death, vascular events and transfusion requirements. Adults with trauma who are within 8 hours of injury and have either significant haemorrhage, or who are considered to be at risk of significant haemorrhage, are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use an antifibrinolytic agent. Numbered drug or placebo packs will be available in each participating emergency department. Randomisation will involve calling a 24-hour freecall randomisation service. The call should last only a minute or two and at the end of it the randomisation service will specify which numbered treatment pack to use. For hospitals where telephone randomisation is not feasible, randomisation will be by taking the next consecutively numbered treatment pack. No extra tests are required but a short form must be completed one month later or on discharge or on death (whichever occurs first).
>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 34
Tranexamic Acid 30
Postpartum Hemorrhage 23
Hemorrhage 23
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Condition MeSH

Condition MeSH for Tranexamic Acid
Intervention Trials
Hemorrhage 232
Postpartum Hemorrhage 48
Blood Loss, Surgical 42
Osteoarthritis 34
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Clinical Trial Locations for Tranexamic Acid

Trials by Country

Trials by Country for Tranexamic Acid
Location Trials
United States 237
Canada 68
Egypt 59
China 38
India 36
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Trials by US State

Trials by US State for Tranexamic Acid
Location Trials
New York 30
California 18
Pennsylvania 17
Illinois 15
Michigan 13
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Clinical Trial Progress for Tranexamic Acid

Clinical Trial Phase

Clinical Trial Phase for Tranexamic Acid
Clinical Trial Phase Trials
Phase 4 175
Phase 3 128
Phase 2/Phase 3 20
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Clinical Trial Status

Clinical Trial Status for Tranexamic Acid
Clinical Trial Phase Trials
Completed 221
Recruiting 112
Unknown status 86
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Clinical Trial Sponsors for Tranexamic Acid

Sponsor Name

Sponsor Name for Tranexamic Acid
Sponsor Trials
Aswan University Hospital 19
Cairo University 16
Assiut University 16
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Sponsor Type

Sponsor Type for Tranexamic Acid
Sponsor Trials
Other 770
Industry 28
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