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Fibrinogen

Phase 2

Postpartum Haemorrhage | Small molecule | Other |Haemonetics Corporation|Last Updated: Sep 20, 2013

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_CONTROLLEDDMC
Total Trials1
Total Enrollment249
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01359878Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled TrialPHASE2 COMPLETED 249 — — May 1, 2011Jul 1, 2013Sep 20, 20134 Denmark
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Study Endpoints
Primary Endpoints
Incidense of transfusion with allogenic blood products
During hospital stay or until 6 weeks postintervention
Secondary Endpoints
Severe Postpartum Haemorrhage (PPH)
During hospital stay or until 6 weeks postintervention
Estimated blood loss
During hospital stay During hospital stay or until 6 weeks postintervention
Total amount of blood transfused
During hospital stay During hospital stay or until 6 weeks postintervention
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
Fibrinogen ConcentrateEXPERIMENTAL -
PlaceboPLACEBO_COMPARATORIsotonic Saline
Interventions
NameTypeDescription
Fibrinogen ConcentrateDRUG2 gram intra venous
Isotonic SalineDRUGIsotonic saline in equivalent volume - 100 ml
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Informed consent from participant. 2. Women who develop PPH defined as bleeding from uterus and/or the birth canal within 24 hours postpartum. 3. Age ≥ 18 years. 4. If vaginal birth: indication of one of the following procedures at the operation theatre with anaesthetic assis...

Countries:Denmark
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