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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/NCT00680446




Registration number
NCT00680446
Ethics application status
Date submitted
16/05/2008
Date registered
20/05/2008
Date last updated
19/06/2013

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
CSLCT-SCIG-07-42
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
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 - 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

Outcomes
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

Eligibility
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 Patients must have completed or withdrawn from CSLCT-SCIG-05-23 and wish to continue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
administration.

4. Patient is capable of self-administering Ig NextGen 16%
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
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
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2013
Sample size
Target
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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
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
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
https://clinicaltrials.gov/ct2/show/NCT00680446
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical and Research Director
Address 0 0
CSL
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/NCT00680446