Back to resultsIg NextGen 10% in Patients With Primary Immune Deficiency (PID)
Primary Purpose
Primary Immune Deficiency (PID)
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
IntragamP
Ig NextGen 10%
Sponsored by
About this trial
This is an interventional treatment trial for Primary Immune Deficiency (PID) focused on measuring PID, IVIg, IntragamP
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
Sites / Locations
- Flinders Medical Centre
- Royal Adelaide Hospital
- The Alfred Hospital
- The Royal Melbourne Hospital
Outcomes
Primary Outcome Measures
IgG Trough Pharmacokinetics
Secondary Outcome Measures
Safety and tolerability, Pharmacokinetics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00405184
Brief Title
Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Deficiency (PID)
Keywords
PID, IVIg, IntragamP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
IntragamP
Intervention Description
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
Intervention Name(s)
Ig NextGen 10%
Intervention Description
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.
Primary Outcome Measure Information:
Title
IgG Trough Pharmacokinetics
Time Frame
one month
Secondary Outcome Measure Information:
Title
Safety and tolerability, Pharmacokinetics
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Bleasel, Dr
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Flinders Medical Centre
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
22212346
Citation
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.
Results Reference
result
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Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)
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