Recent Updates
Recently added Catalysts

Phlebotomy, Erythrocytapheresis

Phase 3

Hemochromatosis | Unknown | Other |Atrium Therapeutics, Inc.|Last Updated: Oct 20, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00202436Haemochromatosis:Phlebotomy Versus Erythrocytapheresis TherapyPHASE3 COMPLETED 40Oct 1, 2004Sep 1, 2009Oct 20, 20091 Netherlands
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Treatment duration and number of treatments
Ferritine value 50 microgr/l
Secondary Endpoints
Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs
Ferritine value 50microgr/l
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORPhlebotomy
2ACTIVE_COMPARATORErythrocytapheresis
Interventions
NameTypeDescription
PhlebotomyPROCEDURERemoval of 500 ml whole blood
ErythrocytapheresisPROCEDUREmachinal removal of erythrocytes
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Hereditary haemochromatosis patients Exclusion Criteria: * Malignancies, severe arrhythmias, congestive heart failure and/or recent angina, severe liver disease, epileptic seizures preceding in last 3 months before planned treatment

Countries:Netherlands
Unlock Eligibility Criteria