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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/NCT00391131




Registration number
NCT00391131
Ethics application status
Date submitted
20/10/2006
Date registered
23/10/2006
Date last updated
7/06/2012

Titles & IDs
Public title
Subcutaneous Ig NextGen 16% in PID Patients
Scientific title
A Multi-centre, Open-label Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Subcutaneous Infusions of Ig NextGen 16% in Patients With Primary Immunodeficiency (PID).
Secondary ID [1] 0 0
CSLCT-SCIG-05-23
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Immunodeficiency (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 - IgNextGen 16%

Experimental: Ig NextGen 16% -


Treatment: Drugs: IgNextGen 16%
IgNextGen 16% administered subcutaneously on a weekly basis from visit 1 to 12
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy
Timepoint [1] 0 0
Continually from Visits 7 to 12 & monthly IgG troughs
Secondary outcome [1] 0 0
Safety, Tolerability, Quality of Life, Pharmacokinetics
Timepoint [1] 0 0
Visits 0, 6, 9, and12

Eligibility
Key inclusion criteria
-

- Males or females 3 years of age or greater and at least 13 kg at enrolment.

- PID patients receiving Ig replacement therapy, with a diagnosis of X-linked
agammaglobulinemia (XLA) or Common Variable immunodeficiency (CVID) with severe
hypogammaglobulinemia.

- Patients who have received a consistent dose of Intragam®P at 3-, 4-, 5- or
6-weekly intervals, within the range of 0.2 - 0.6 g/kg body weight, for at least
six months prior to the Screening visit.

- Patients must have maintained IgG trough serum level of = 5 g/L during the six
months prior to Visit 0, with at least two trough levels to have been documented
during this period.

- Patients and/or their legally acceptable representative/guardian must give
written informed consent to participate in the study and must understand the
nature of the study and must be willing to comply with all protocol requirements
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- • Patients newly diagnosed with PID within six months of the Screening visit.

- Patients with known or suspected severe hypersensitivity or previous evidence of
severe side effects to immunoglobulin therapy or other blood products

- Patients with known selective IgA deficiency or antibodies to IgA

- Patients receiving immunosuppressive treatment other than topical and/or inhaled
steroids and low dose oral steroids.

- Females who are pregnant, breast feeding or planning a pregnancy during the
course of the study. Females who are of child bearing potential must have a
negative pregnancy test at screening.

- Patients with protein-losing enteropathies, and kidney diseases with substantial
proteinuria

- Patients with malignancies of lymphoid cells such as chronic lymphocytic
leukaemia, Non-Hodgkin's lymphoma and immunodeficiency with thymoma.

- Patients who have within 30 days priors to the study screening visit,
participated in a clinical study or used an investigational compound (eg: a new
chemical entity not registered for clinical use).

- Patients with any of the following abnormal lab results:

- Serum creatinine >1.5 x Upper limit of Normal (ULN).

- Serum ALT & AST > 2.5 x ULN.

- Albumin < 25 g/L

- Patients who are suffering from an acute or chronic medical condition, other than
PID, which may, in the opinion of the Investigator, affect the conduct of the
trial.

- Patients who are not willing or are unable to comply with protocol.

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
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2009
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [3] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Women's & Children's Hospital - North Adelaide
Recruitment hospital [6] 0 0
Frankston Hospital - Frankston
Recruitment hospital [7] 0 0
Royal Children's Hospital - Melbourne
Recruitment hospital [8] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5006 - North Adelaide
Recruitment postcode(s) [6] 0 0
- Frankston
Recruitment postcode(s) [7] 0 0
3052 - Melbourne
Recruitment postcode(s) [8] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington

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, efficacy and pharmacokinetics of Ig
NextGen 16% in people with antibody deficiency currently being treated with IntragamP. Ig
NextGen 16% is a liquid immunoglobulin (antibody) preparation manufactured using
predominately chromatographic techniques. Eligible patients will switch from monthly
intravenous IntragamP therapy to weekly subcutaneous Ig NextGen 16% treatment. Initial
hospital training will be required for subcutaneous administration and then the patient will
perform the infusion in their own home, returning once a month for a supervised infusion.
Patients will be monitored on the study for up to 10 months to assess blood IgG levels and
rate of serious bacterial infections.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00391131
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marianne Empson, Dr
Address 0 0
Auckland City Hospital
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/NCT00391131