Ig NextGen 10% in Patients With Primary Immune Deficiency (PID) - Full Text View

Sponsored by:	CSL Limited
Information provided by:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00405184

Purpose

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.

Condition	Intervention	Phase
Primary Immune Deficiency (PID)	Drug: IntragamP Drug: Ig NextGen 10%	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Crossover Assignment, Efficacy Study
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)

Further study details as provided by CSL Limited:

Primary Outcome Measures:

IgG Trough Pharmacokinetics [ Time Frame: one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability, Pharmacokinetics [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment:	19
Study Start Date:	June 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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% - 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405184

Locations

Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Australia, Victoria
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia

Sponsors and Collaborators

CSL Limited

Investigators

Principal Investigator:

Karl Bleasel, Dr

Melbourne Health

More Information

No publications provided

Responsible Party:	CSL Limited ( Dr Darryl Maher )
Study ID Numbers:	CSLCT-PID-05-22
Study First Received:	November 27, 2006
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00405184 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by CSL Limited:

PID
IVIg
IntragamP

ClinicalTrials.gov processed this record on September 03, 2009