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KamRAB - HRIG

Phase 3

Rabies | Small molecule | Other |Kamada Ltd.|Last Updated: Sep 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
UNCONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02912845Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to RabiesPHASE3 COMPLETED 30 — — Aug 1, 2016Nov 13, 2019Sep 5, 20211 United States
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Study Endpoints
Primary Endpoints
Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment
Within 14 days from treatment
Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment
Within 84 days of treatment
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
20 IU/kg KamRAB + Active Anti-Rabies VaccineEXPERIMENTAL -
Interventions
NameTypeDescription
KamRAB - HRIGDRUGwound infiltration or IM injection
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Eligibility Criteria
Age Range0 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Healthy children (male and female) ages 0 months to \<17 years. * Have been exposed or possibly exposed to rabies. * Are indicated to receive post-exposure prophylaxis (PEP) against rabies infection. * Have documented informed consent from the child's parent(s) or legal guardi...

Countries:United States
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