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Ciclosporin

Phase 2

Myocardial Reperfusion Injury | Small molecule | Cardiovascular |United Therapeutics Corporation|Last Updated: Mar 29, 2018

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02390674Ciclosporin to Reduce Reperfusion Injury in Primary PCIPHASE2 COMPLETED 54Mar 1, 2015Nov 11, 2017Mar 29, 20181 United Kingdom
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Study Endpoints
Primary Endpoints
Change in infarct size
12 weeks after primary percutaneous coronary intervention (PPCI)

Change in infarct size 12 weeks post-PPCI as measured by cardiac MRI

Secondary Endpoints
Change in microvascular obstruction
Measured once between day 2 and day 7 after PPCI
Change in salvage index
Measured once between day 2 and day 7 after PPCI
Change in T lymphocyte count
5, 15, 30, 60 and 90 minutes
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CiclosporinACTIVE_COMPARATORSingle intravenous administration of ciclosporin (2.5mg per kilogram body weight) immediately prior to reperfusion during primary percutaneous coronary intervention. Ciclosporin is dissolved in saline (maximum concentration 2.5mg per millilitre)
SalinePLACEBO_COMPARATORSingle intravenous administration of placebo (saline) immediately prior to reperfusion during primary percutaneous coronary intervention
Interventions
NameTypeDescription
CiclosporinDRUGComparison between ciclosporin and placebo
SalineDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients presenting with acute myocardial infarction (STEMI) and undergoing primary percutaneous coronary intervention (PPCI) * Age above 18 years * Presenting within 6 hours of the onset chest pain and ST segment elevation. The culprit coronary artery has to be a major corona...

Countries:United Kingdom
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