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

NCT ID: NCT00405184

Last Updated: 2012-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-07-31

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl Bleasel, Dr

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Locations

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, Australia

Countries

Australia

References

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.

Reference Type: RESULT

PMID: 22212346 (View on PubMed)

Other Identifiers

CSLCT-PID-05-22

Identifier Type: -

Identifier Source: org_study_id