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Gammagard S/D

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Gammagard S/D · 1 trial · 3 indications

Phase 2 1
NCT00161993Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)Primary Immunodeficiency Diseases (PID)
COMPLETED24 Analytics
PHASE2COMPLETED
Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)
Primary Immunodeficiency Diseases (PID)
NCT0016199324
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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 to 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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Frequently asked questions about Gammagard S/D

What is Gammagard S/D used for?

Gammagard S/D is an investigational therapy being studied for Primary Immunodeficiency Diseases (PID), including hypo- or agammaglobulinemia. It is a small molecule developed by Takeda Pharmaceutical Company Limited. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Gammagard S/D?

Gammagard S/D is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this investigational therapy for Primary Immunodeficiency Diseases. As of the latest data, the drug is in Phase 2 development and remains unapproved.

What phase is Gammagard S/D in?

Gammagard S/D is in Phase 2 clinical development. It is an investigational therapy for Primary Immunodeficiency Diseases and has not received regulatory approval. The drug is being studied by Takeda Pharmaceutical Company Limited, and its development status reflects ongoing clinical evaluation.

What clinical trials is Gammagard S/D in?

Gammagard S/D has one completed Phase 2 clinical trial, NCT00161993, which evaluated the safety, pharmacokinetics, and efficacy of a 10% triple virally reduced intravenous immune globulin solution in patients with Primary Immunodeficiency (hypo- or agammaglobulinemia). The trial enrolled 24 participants in Finland and Sweden.

Is Gammagard S/D FDA approved?

Gammagard S/D is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Primary Immunodeficiency Diseases. The therapy is being developed by Takeda Pharmaceutical Company Limited, and its safety and efficacy have not been established for regulatory approval.