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Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency

2014-07-24 14:17:39 | BioPortfolio

Summary

The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement therapy. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation.

Description

This is a Phase 3, open label, multi-centre, study for patients requiring Ig replacement therapy. This study is a follow-on study to patients who have completed the CSLCT-SCIG-05-23 clinical trial and wish to continue subcutaneous treatment with Ig NextGen 16% . Additionally, patients currently receiving IVIg with unacceptable adverse reactions or unable to tolerate IVIg as well as patients receiving alternate IG products via the SC route may be enrolled in this study. Patients must not be eligible for any of the Sponsor's ongoing PID studies that are still open to enrolment.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Primary Immune Deficiency

Intervention

Immunoglobulin G (Ig NextGen 16%)

Location

Canberra Hospital
Garran
Australian Capital Territory
Australia
2605

Status

Recruiting

Source

CSL Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:17:39-0400

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Medical and Biotech [MESH] Definitions

A dysgammaglobulinemia characterized by a deficiency of IMMUNOGLOBULIN A.

A dysgammaglobulinemia characterized by a deficiency of IMMUNOGLOBULIN G.

Type-I membrane glycoproteins that are expressed primarily on the surface of CD4 or CD8-positive T-CELLS; NATURAL KILLER CELLS; and some populations of B CELLS. They are characterized by an N-terminal, extracellular IMMUNOGLOBULIN-LIKE DOMAIN and a membrane-proximal IMMUNOGLOBULIN C2-SET DOMAIN. SLAMF receptors typically signal through homophilic interactions and are important for mediating the immune response and immune cell differentiation.

Immunoglobulin preparations used in intravenous infusion, containing primarily IMMUNOGLOBULIN G. They are used to treat a variety of diseases associated with decreased or abnormal immunoglobulin levels including pediatric AIDS; primary HYPERGAMMAGLOBULINEMIA; SCID; CYTOMEGALOVIRUS infections in transplant recipients, LYMPHOCYTIC LEUKEMIA, CHRONIC; Kawasaki syndrome, infection in neonates, and IDIOPATHIC THROMBOCYTOPENIC PURPURA.

A cytokine synthesized by T-LYMPHOCYTES that produces proliferation, immunoglobulin isotype switching, and immunoglobulin production by immature B-LYMPHOCYTES. It appears to play a role in regulating inflammatory and immune responses.

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