Other Clinical Trial - Safety & Efficacy Study of a 10% Intravenous Immune

Updated 04/26/2024

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Immune Thrombocytopenic Purpura (ITP)
Immunologic Deficiency Syndromes
Kawasaki Syndrome
Mucocutaneous Lymph Node Syndrome
Primary Immunodeficiency Diseases (PID)
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic

Clinical Trial Details

NCT number	NCT00157079
Study type	Interventional
Source	Takeda
Contact
Status	Completed
Phase	Phase 3
Start date	June 25, 2002
Completion date	December 16, 2003

See also
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	Active, not recruiting	`NCT05513586` - A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants	Phase 3
	Recruiting	`NCT05986734` - Evaluation of Subcutaneous Immunoglobulin Product Cutaquig in Terms of Safety and Efficacy in the Treatment of Patients With Primary Immunodeficiencies
	Completed	`NCT00546871` - Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects	Phase 2/Phase 3
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	Completed	`NCT02593188` - Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
	Completed	`NCT03116347` - Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects	Phase 4
	Completed	`NCT01412385` - Immune Globulin Subcutaenous (Human), 20%	Phase 2/Phase 3
	Completed	`NCT00161993` - Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)	Phase 2
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	Completed	`NCT01218438` - Phase 2/3 Study of IGSC, 20% in PIDD	Phase 2/Phase 3
	Completed	`NCT05150340` - A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID)	Phase 3
	Not yet recruiting	`NCT06076642` - A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases	Phase 3
	Completed	`NCT00782106` - Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously	Phase 1/Phase 2
	Completed	`NCT01485796` - Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD	Phase 2/Phase 3
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	Completed	`NCT04346108` - A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)	Phase 3