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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00405184




Registration number
NCT00405184
Ethics application status
Date submitted
27/11/2006
Date registered
29/11/2006
Date last updated
7/06/2012

Titles & IDs
Public title
Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)
Scientific 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)
Secondary ID [1] 0 0
CSLCT-PID-05-22
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Immune Deficiency (PID) 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IntragamP
Treatment: Drugs - Ig NextGen 10%

Treatment: Drugs: 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.

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
IgG Trough Pharmacokinetics
Timepoint [1] 0 0
one month
Secondary outcome [1] 0 0
Safety and tolerability, Pharmacokinetics
Timepoint [1] 0 0
9 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CSL Limited
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00405184
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karl Bleasel, Dr
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00405184