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Plasmin

Phase 1

Arterial Occlusive Diseases | Monoclonal antibody | Other |Grifols, S.A.|Last Updated: Oct 31, 2016

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
CONTROLLEDDMC
Total Trials1
Total Enrollment83
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00418483A Dose Escalation and Safety Study of Plasmin (Human) In Acute Lower Extremity Native Artery or Bypass Graft OcclusionPHASE1 COMPLETED 83 — — Mar 1, 2007Apr 1, 2010Oct 31, 20161 United States
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Study Endpoints
Primary Endpoints
Thrombolysis
Approximately 5 hours after start of treatment

Thrombolysis at the end of treatment compared to baseline by arteriography

Secondary Endpoints
Thrombolysis
Approximately 2 hours after start of treatment
Avoidance of open surgical procedures
30 days
Avoidance of amputation
30 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Plasmin (Human) 25 mgEXPERIMENTALPlasmin (Human) 25 mg
Plasmin (Human) 50 mgEXPERIMENTALPlasmin (Human ) 50 mg
Plasmin (Human) 75 mgEXPERIMENTALPlasmin (Human) 75 mg
Plasmin (Human) 100 mgEXPERIMENTALPlasmin (Human) 100 mg
Plasmin (Human) 125 mgEXPERIMENTALPlasmin (Human) 125 mg
Plasmin (Human) 150 mgEXPERIMENTALPlasmin (Human) 150 mg
Plasmin (Human) 175 mgEXPERIMENTALPlasmin (Human) 175 mg
Interventions
NameTypeDescription
Plasmin (Human) 25 mgBIOLOGICALPlasmin (Human) 25 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
Plasmin (Human) 50 mgBIOLOGICALPlasmin (Human) 50 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
Plasmin (Human) 75 mgBIOLOGICALPlasmin (Human) 75 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
Plasmin (Human) 100 mgBIOLOGICALPlasmin (Human) 100 mg
Plasmin (Human) 125 mgBIOLOGICALPlasmin (Human) 125 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
Plasmin (Human) 150 mgBIOLOGICALPlasmin (Human) 150 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
Plasmin (Human) 175 mgBIOLOGICALPlasmin (Human) 175 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age ≥ 18 years. * Women of childbearing potential must use adequate contraception for the duration of the study and must have a negative pregnancy test prior to study entry. * Unilateral limb ischemia: SVS acute ischemia Category I or IIa. * Onset of symptoms \</= 14 days. * T...

Countries:United States
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