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Tranexamic acid

Phase 1

Urologic Diseases | Small molecule | Oncology |Smith & Nephew SNATS, Inc.|Last Updated: Nov 5, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

Tranexamic acid · 1 trial · 8 indications

Phase 1 1
NCT04555343Intravesical Antifibrinolytic for Patients With Hematuria and Clot RetentionUrologic Diseases
COMPLETED14 Analytics
PHASE1COMPLETED
Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention
Urologic DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Acceptability of study procedures to participants as assessed by successful consenting retention
20 patients total or a maximum of six months

measured by the number of eligible patients and number that consent to the study intervention

Participant recruitment time as measured by the time between identification of patient to consent completion
20 patients total or a maximum of six months

Patient triage time will be compared to time consent was obtained

Times to intervention- measured by time from consent to time intervention initiated
20 patients total or a maximum of six months

all participants will have consent and intervention time documented

Secondary Endpoints

Trial site appropriateness as measured by total number of participants recruited within study time
20 patients total or a maximum of six months
Incidence of treatment emergent adverse events as assessed by the CTCAE v3.0 severity scale
20 patients total or a maximum of six months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Intervention- TXAEXPERIMENTALDrug: one-time intravesical administration of 1gm of TXA instilled via urinary catheter, instilled for 15min before continuous bladder irrigation treatment beings. 1gm of TXA will be mixed with 100cc NS

Interventions

NameTypeDescription
Tranexamic acidDRUG1gm instilled instravesically
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * 18 years of age or older * complaint of hematuria or urinary retention * requiring CBI treatment * able to consent to the study. Exclusion Criteria: * Pregnancy or breastfeeding * Use of anticoagulants (warfarin, heparin, DOACs, etc.) * known coagulopathy (genetic bleeding d...

Countries:Canada
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Frequently asked questions about Tranexamic acid

What is Tranexamic acid used for in urologic diseases?

Tranexamic acid is being studied for use in urologic diseases, specifically for patients with hematuria and clot retention. It is an investigational small molecule in Phase 1 clinical development. The completed trial enrolled 14 participants with conditions including prostate cancer, bladder cancer, urinary retention, and hematuria.

What does Tranexamic acid target?

Tranexamic acid is an antifibrinolytic agent, meaning it works by inhibiting fibrinolysis, the process that breaks down blood clots. This mechanism helps stabilize clots and reduce bleeding. In the context of the clinical trial, it is administered intravesically, directly into the bladder, to manage hematuria and clot retention.

Who makes Tranexamic acid?

Tranexamic acid is being developed by Smith & Nephew SNATS, Inc., a subsidiary of Smith & Nephew plc, which trades under the ticker SNN. The company is conducting clinical research on this drug for urologic indications, specifically targeting hematuria and clot retention in patients with urologic diseases.

What phase is Tranexamic acid in?

Tranexamic acid is in Phase 1 clinical development. The single clinical trial for this drug, NCT04555343, has been completed. It is an investigational drug and has not been approved by regulatory authorities for the studied indication. The trial was uncontrolled, non-randomized, and not double-blinded.

What clinical trials is Tranexamic acid in?

Tranexamic acid has one completed clinical trial, NCT04555343, titled 'Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention.' This Phase 1 study enrolled 14 participants in Canada, aged 18 years and older, and included both males and females. The trial was uncontrolled and did not use randomization or blinding.

Is Tranexamic acid the same as other antifibrinolytics?

Tranexamic acid is a specific antifibrinolytic agent. While it shares a mechanism with other drugs in its class, such as aminocaproic acid, it is a distinct chemical entity. The clinical trial data provided does not indicate any alternative names for this drug, so it is referred to solely as tranexamic acid.