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

NCT00405184 | Completed Phase 3

• 1 other identifier: CSLCT-PID-05-22
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

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.

Conditions

Primary Immune Deficiency (PID)

Keywords

PID; IVIg; IntragamP

Outcome Measures

Primary Outcomes (1)

• IgG Trough Pharmacokinetics

  one month

Secondary Outcomes (1)

• Safety and tolerability, Pharmacokinetics

  9 months

Interventions

IntragamP DRUG

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% DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CSL Limited: lead

Study Sites (4)

Flinders Medical Centre

Adelaide, South Australia, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

The Alfred Hospital

Melbourne, Victoria, Australia

Location

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

Location

Related 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. doi: 10.1111/j.1445-5994.2011.02712.x.

  PMID: 22212346 RESULT

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Karl Bleasel, Dr

  Melbourne Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2006
• First Posted: November 29, 2006
• Study Start: May 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: June 7, 2012

Record last verified: 2012-06

Locations

AU (4)