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Tranexamic acid

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04555343Intravesical Antifibrinolytic for Patients With Hematuria and Clot RetentionPHASE1 COMPLETED 14 — — Mar 1, 2021Oct 30, 2021Nov 5, 20212 Canada
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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 — 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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