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IGIV3I Grifols

Phase 3

Immune (Idiopathic) Thrombocytopenic Purpura | Monoclonal antibody | Other |Grifols, S.A.|Last Updated: Feb 8, 2016

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 Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00699140Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic PurpuraPHASE3 COMPLETED 18 — — Feb 1, 2008Dec 1, 2013Feb 8, 20167 Russia, Spain +1
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Study Endpoints
Primary Endpoints
Responder Patients
At any time during the study period (The platelet count was measured at Days 1-6, 10, 14. 21, 30, 60, 90).

The primary efficacy endpoint was the proportion of patients who reached a platelet count ≥ 50x10\^9/L.

Secondary Endpoints
Maximum Platelet Level Reached During the Follow-up Period
During the follow-up period (time points: Days 6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])
Time to Reach Platelet Count ≥ 50x10^9/L (≤ Days)
At any time during the study period (time points: Days 1-6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])
Length of Time Platelet Count Remains ≥ 50x10^9/L (≥ Days)
At any time during the study period (up to 3 months [90 days])
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1 treatment group with IGIV3I GrifolsEXPERIMENTALOpen label, non-randomized treatment group with IGIV3I Grifols Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.
Interventions
NameTypeDescription
IGIV3I GrifolsBIOLOGICALImmune Globulin Intravenous (Human)
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Eligibility Criteria
Age Range18 Years — 82 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Be aged between 18 and 82 at the time of written consent. 2. Have confirmed diagnosis of chronic ITP and fulfil all the following criteria: * irrelevant history except for the symptoms of bleeding, * pattern of bleedings associated with platelet disorders, * physica...

Countries:RussiaSpainUnited Kingdom
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