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

A Multi-centre, Open-label, Cross-over Study to Compare the Pharmacokinetics, Safety and Tolerability of Ig NextGen 10% With Intragam P in Patients With Primary Immune Deficiency (PID)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00405184

Enrollment

Registered

2006-11-29

Start date

2007-05-31

Completion date

2008-07-31

Last updated

2012-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Immune Deficiency (PID)

Keywords

PID, IVIg, IntragamP

Brief summary

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.

Interventions

DRUGIntragamP

IntragamP - dosage based on previous dose of IntragamP prior to study entry. One cycle (Cycle 0)only administered, with dosage calculation based on body weight on Day 1 of the study and must be between 0.2-0.8 g/kg body weight. IntragamP to be administered intravenously.

DRUGIg NextGen 10%

Ig NextGen 10% - dosage based on previous dose of IntragamP in Cycle 0. Dosage calculation to use body weight on Day 1 of Cycle 1 of the study and must be between 0.2-0.8 g/kg body weight. 7 cycles administered, and patients to be dosed at 3 to 4 week intervals (in accordance with previous dosage schedule with IntragamP). Ig NextGen 10% to be administered intravenously.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
IgG Trough Pharmacokinetics	one month

Secondary

Measure	Time frame
Safety and tolerability, Pharmacokinetics	9 months

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026