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eltrombopag olamine

Phase 3

Purpura, Thrombocytopaenic, Idiopathic | Small molecule | Other |Novartis AG|Last Updated: Apr 17, 2017

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 Enrollment302
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00351468EXTEND (Eltrombopag Extended Dosing Study)PHASE3 COMPLETED 302 — — Jun 1, 2006Jul 1, 2015Apr 17, 2017110 United States, Australia +29
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Study Endpoints
Primary Endpoints
Overall Summary of On-Therapy Adverse Events (Safety Population)
Start date was the first dose of investigational product and up to the day after the last dose . Post-therapy: start date was more than 1 day after the last dose and up to 30 days after last dose of investigational product up to week 364

All safety evaluation findings considered to be adverse events are reported in the Adverse Event section.

Secondary Endpoints
Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication
Baseline up to 2 years
Summary of Subjects Achieving Platelet Count Levels by Week, in the Absence of Rescue Medication
Baseline up to Year 7/Week 364
Number of Subjects Who Responded to Eltrombopag in a Previous Study and Who Respond to Retreatment With a Rise in Platelet Count to Either ≥ 50,000/µL or ≥30,000/µL
Baseline up to 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EltrombopagEXPERIMENTALOpen-label eltrombopag
Interventions
NameTypeDescription
eltrombopag olamine (SB-497115-GR)DRUGEltrombopag with starting dose of 50mg daily, max dose of 75mg daily and min dose of 25mg daily or less frequently. Modifications were given to maintain platelet count in range of 50 to 200 Gi/L.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites110

Inclusion Criteria: * Subject has signed and dated a written informed consent. * Adults (≥18 years) diagnosed with ITP according to the American Society for Hematology/British Committee for Standards in Haematology (ASH/BCSH) guidelines \[George, 1996; BCSH, 2003\]. In addition, a peripheral blood ...

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