Other Clinical Trial - Non-Interventional Post-Marketing Safety Study on

Updated 05/14/2024

Status Completed

Clinical Trial Summary

The purpose of the proposed study is to acquire additional data (including the assessment of anti-rHuPH20 antibodies) on the long-term safety of HYQVIA and to assess the prescribed treatment regimens and treatment administration in routine clinical practice.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Immunologic Deficiency Syndromes
Primary Immunodeficiency Diseases
Primary Immunodeficiency Diseases (PID)

Clinical Trial Details

NCT number	NCT02593188
Study type	Observational
Source	Takeda
Contact
Status	Completed
Phase
Start date	November 12, 2015
Completion date	October 21, 2021

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
	Recruiting	`NCT05755035` - A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases	Phase 2/Phase 3
	Completed	`NCT03116347` - Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects	Phase 4
	Completed	`NCT00157079` - Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders	Phase 3
	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
	Completed	`NCT01175213` - Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID	Phase 3
	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
	Recruiting	`NCT06150534` - At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill
	Completed	`NCT00814320` - Gammagard Liquid and rHuPH20 in PID	Phase 3
	Completed	`NCT04346108` - A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)	Phase 3