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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency
Scientific title
An Open-Label Study of Ig NextGen 16% Administered by Subcutaneous Infusion in Patients With Primary Immunodeficiency (PID).
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Immune Deficiency 0 0
Condition category
Condition code

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Immunoglobulin G (Ig NextGen 16%)

Experimental: 1 -

Treatment: Drugs: Immunoglobulin G (Ig NextGen 16%)
Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G

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

Primary outcome [1] 0 0
Rate, Severity and Relatedness of reported Adverse Events
Timepoint [1] 0 0
Up to Four Years
Secondary outcome [1] 0 0
To monitor patient IgG trough levels while receiving Ig NextGen 16%
Timepoint [1] 0 0
Up to 4 years

Key inclusion criteria
1. Age >3 years of age.

2. PID patients receiving Ig replacement therapy.

3. Patients must have completed or withdrawn from CSLCT-SCIG-05-23 and wish to continue
SCIg therapy; or, patients ineligible for CSLCT-SCIG-05-23 but for whom the
Investigator believes SCIg may be a suitable form of Ig replacement, for reasons such
as: poor tolerability of IVIg, difficult venous access, or, preferred route of

4. Patient is capable of self-administering Ig NextGen 16%
Minimum age
3 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Patients eligible for CSLCT-SCIG-05-23 if still open for recruitment.

2. Patients with known anaphylaxis reactions to immunoglobulin therapy.

3. Patients with known selective IgA deficiency or antibodies to IgA with a history of
reactions to Ig therapy.

4. Patients with protein-losing enteropathies.

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

6. 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.

7. Patients unwilling to comply with the protocol.

Study design
Purpose of the study
Allocation to intervention
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 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Women's & Children's Hospital - North Adelaide
Recruitment hospital [5] 0 0
Frankston Hospital - Frankston
Recruitment hospital [6] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Country [2] 0 0
New Zealand
State/province [2] 0 0
Country [3] 0 0
New Zealand
State/province [3] 0 0

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

Ethics approval
Ethics application status

Brief summary
The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in
patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement
therapy. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Medical and Research Director
Address 0 0
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
Other publications