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Romiplostim

Phase 2

Aplastic Anemia | Small molecule | Hematology |Co-Diagnostics, Inc.|Last Updated: May 26, 2022

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04095936Study of AMG531 (Romiplostim) in Patients With Aplastic AnemiaPHASE2 COMPLETED 24Dec 3, 2019Oct 29, 2021May 26, 20221 Japan
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Study Endpoints
Primary Endpoints
Rate of achievement of complete response (CR) or partial response (PR)
27 weeks post-dose
Secondary Endpoints
Rate of achievement of CR or PR
14 weeks
Rate of achievement of CR
Weeks 14 and 27
The time to CR or PR
Each time point evaluated weekly until Week 27
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AMG531EXPERIMENTAL -
Interventions
NameTypeDescription
RomiplostimDRUGSubcutaneous administration of 0 to 20ug/kg for 6 months
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Voluntary signed informed consent to participate in the study; 2. A diagnosis of AA confirmed by blood and bone-marrow examinations, etc.; 3. Considered to require new treatment with immunosuppressive therapy provided that NSAA must be platelet or erythrocyte transfusion-depe...

Countries:Japan
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Competitive Landscape -Aplastic Anemia 4 trials
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