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Kamada-API

Phase 2

Alpha 1-Antitrypsin Deficiency | Small molecule | Other |Kamada Ltd.|Last Updated: Oct 17, 2007

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-BlindUNCONTROLLEDDMC
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00460096Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin DeficiencyPHASE2 COMPLETED 50Mar 1, 2007Sep 1, 2007Oct 17, 20073 United States
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Study Endpoints
Primary Endpoints
Efficacy
Secondary Endpoints
Safety
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
Kamada-APIDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Signed informed consent. 2. "At-risk" alleles associated with serum AAT \< 11 μM including null alleles and deficiency alleles. This must be documented in the subject's history or laboratory tests performed at screening. 3. At least 18 years of age. 4. Evidence of lung diseas...

Countries:United States
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