Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)

CSL Limited

Status and phase

Completed

Phase 3

Conditions

Primary Immune Deficiency (PID)

Treatments

Drug: IntragamP

Drug: Ig NextGen 10%

Study type

Interventional

Funder types

Industry

Identifiers

NCT00405184

CSLCT-PID-05-22

Details and patient eligibility

About

This study aims to assess the safety, tolerability and pharmacokinetics of Ig NextGen 10% in patients with primary immune deficiency currently being treated with Intragam P. Eligible patients will switch from 3 to 4 weekly intravenous Intragam P therapy to receive seven cycles of Ig NextGen 10% treatment administered intravenously at three- to four-weekly intervals. Patients will be monitored on the study for up to 36 weeks.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of PID
= or >6 month use of Intragam P at three- or four-weekly intervals
= or >6 month history of IgG trough levels of ≥ 5 g/L

Exclusion criteria

Newly diagnosed PID within six months prior to Screening
Known selective IgA deficiency or antibodies to IgA
Immunosuppressive treatment other than topical and/ or inhaled steroids and/ or low dose oral steroids
Protein-losing enteropathies, or kidney diseases
History of malignancies of lymphoid cells
Any of the following laboratory results at Screening:
Serum Creatinine > 1.5 times the upper normal limit (UNL)
AST or ALT concentration > 2.5 times the UNL
Albumin < 25 g/L