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FS Grifols

Phase 2

Target Bleeding Site During Peripheral Vascular Surgery | Monoclonal antibody | Other |Grifols, S.A.|Last Updated: Jan 25, 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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment239
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00684047Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to HemostasisPHASE2 COMPLETED 239 — — Feb 1, 2008May 1, 2014Jan 25, 201619 Canada, Spain +1
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Study Endpoints
Primary Endpoints
The Primary Efficacy Endpoint is Time to Hemostasis.
The start of treatment application at the target bleeding site (TBS) to the achievement of hemostasis at that site or to the end of the 10-minute observational period when the hemostasis has not yet been achieved.

The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved.

Secondary Endpoints
Proportions of Subjects Achieving Hemostasis
10 minutes from the start of treatment application at the target bleeding site
Prevalence of Treatment Failures
10 minutes from the start of treatment application at the target bleeding site
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FS Grifols Preliminary Part (I)EXPERIMENTALOpen label administration of FS Grifols to all subjects
FS Grifols Primary Part (II)EXPERIMENTALSingle-blind, randomized (2:1)
Manual Compression Primary Part (II)ACTIVE_COMPARATORSingle-blind, randomized (2:1)
Interventions
NameTypeDescription
FS GrifolsBIOLOGICALFibrin Sealant Grifols (FS Grifols). Preliminary Part (I)
Manual CompressionPROCEDUREManual Compression. Primary Part (II)
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Eligibility Criteria
Age Range3 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Are male or female * Must be at least 3 years of age with no upper age limit (must be at least 18 years of age in Spain and United Kingdom) * Require an elective (non-emergency), open (non-laparoscopic; non-endovascular) peripheral vascular surgical procedure * Have hemoglobin...

Countries:CanadaSpainUnited Kingdom
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