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

Primary Immune Deficiency (PID) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405184
• Other study ID #: CSLCT-PID-05-22
• Status: Completed
• Phase: Phase 3
• First received: November 27, 2006
• Last updated: June 5, 2012
• Start date: May 2007
• Est. completion date: July 2008

Study information

• Verified date: June 2012
• Source: CSL Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immune Deficiency (PID)

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Adelaide	South Australia
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	The Royal Melbourne Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
CSL Limited

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Bleasel K, Heddle R, Hissaria P, Stirling R, Stone C, Maher D. Pharmacokinetics and safety of Intragam 10 NF, the next generation 10% liquid intravenous immunoglobulin, in patients with primary antibody deficiencies. Intern Med J. 2012 Mar;42(3):252-9. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IgG Trough Pharmacokinetics		one month	No
Secondary	Safety and tolerability, Pharmacokinetics		9 months	Yes