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Gammagard S/D

Phase 2

Primary Immunodeficiency Diseases (PID) | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Aug 24, 2021

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
UNCONTROLLED
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00161993Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)PHASE2 COMPLETED 24 — — Jun 13, 2002Sep 24, 2003Aug 24, 20216 Finland, Sweden
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Study Endpoints
Primary Endpoints
Pharmacokinetics: Trough levels of total immunoglobulin G (IgG) after treatment with Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution (IGIV, 10% TVR Solution)
21 days after each infusion (i.e., before the next infusion) of the study drug and at the last visit
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) SolutionDRUG -
Gammagard S/D (Solvent/Detergent)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: Subjects will be eligible for study entry if they: * are at least 18 years old * have a form of primary immunodeficiency (PID) as described by Rosen et al, 1999 16 manifesting as agammaglobulinemia (X-linked) or hypogamma-globulinemia (common variable immunodeficiency), requiri...

Countries:FinlandSweden
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