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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Primary Immune Deficiency (PID)

Intervention / Treatment
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* Drug: IntragamP
* Drug: Ig NextGen 10%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: IntragamP|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.|
|Drug: Ig 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgG Trough Pharmacokinetics |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability, Pharmacokinetics |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PID, IVIg, IntragamP