Primary Immune DeficiencyPhase 3NCT00680446
Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency
A Phase 3 study testing Immunoglobulin G (Ig NextGen 16%) in people with Primary Immune Deficiency, run by CSL Limited at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Primary Immune Deficiency
- What is being tested?
- Immunoglobulin G (Ig NextGen 16%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Apr 2008to May 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >3 years of age.
- PID patients receiving Ig replacement therapy.
- Patients must have completed or withdrawn from CSLCT-SCIG-05-23 and wish to continue SCIg therapy; or, patients ineligible for CSLCT-SCIG-05-23 but for whom the Investigator believes SCIg may be a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.
- Patient is capable of self-administering Ig NextGen 16%
Who cannot join
- Patients eligible for CSLCT-SCIG-05-23 if still open for recruitment.
- Patients with known anaphylaxis reactions to immunoglobulin therapy.
- Patients with known selective IgA deficiency or antibodies to IgA with a history of reactions to Ig therapy.
- Patients with protein-losing enteropathies.
- 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.
- 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 unwilling to comply with the protocol.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Australia6 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Campbelltown Hospital
Campbelltown, New South Wales, 2560
Frankston Hospital
Frankston, Victoria, 3199
Women's & Children's Hospital
North Adelaide, South Australia, 5006
Royal Children's Hospital
Parkville, Victoria, 3052
Sydney Children's Hospital
Randwick, New South Wales, 2031
New Zealand3 sites
Auckland Hospital
Auckland
Christchurch Hospital
Christchurch
Wellington Hospital
Wellington
About this study
Official title: An Open-Label Study of Ig NextGen 16% Administered by Subcutaneous Infusion in Patients With Primary Immunodeficiency (PID).
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.
Read the detailed description
This is a Phase 3, open label, multi-centre, study for patients requiring Ig replacement therapy. This study is a follow-on study to patients who have completed the CSLCT-SCIG-05-23 clinical trial and wish to continue subcutaneous treatment with Ig NextGen 16% . Additionally, patients currently receiving IVIg with unacceptable adverse reactions or unable to tolerate IVIg as well as patients receiving alternate IG products via the SC route may be enrolled in this study. Patients must not be eligible for any of the Sponsor's ongoing PID studies that are still open to enrolment.
- Conditions
- Primary Immune Deficiency
- Being tested
- Immunoglobulin G (Ig NextGen 16%)
- Keywords
- Primary Immune Deficiency, Subcutaneous, Immunoglobulin G
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoglobulin G (Ig NextGen 16%)Drug
Also called Ig NextGen 16%
Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Immunoglobulin G (Ig NextGen 16%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate, Severity and Relatedness of reported Adverse Events
Measured: Up to Four Years
Secondary outcomes (1)
To monitor patient IgG trough levels while receiving Ig NextGen 16%
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical and Research Director, Study director, CSL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680446
- Sponsor's protocol ID
- CSLCT-SCIG-07-42
- Status last verified
- Jun 2013
- First submitted
- 16 May 2008
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Ig NextGen 16% Administered by Subcutaneous Infusion in Patients With Primary Immunodeficiency (PID).
- ClinicalTrials.gov ID
- NCT00680446
- Acronym / sponsor ID
- CSLCT-SCIG-07-42
- Conditions
- Primary Immune Deficiency
- Keywords
- Primary Immune Deficiency, Subcutaneous, Immunoglobulin G
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- CSL LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 3, open label, multi-centre, study for patients requiring Ig replacement therapy. This study is a follow-on study to patients who have completed the CSLCT-SCIG-05-23 clinical trial and wish to continue subcutaneous treatment with Ig NextGen 16% . Additionally, patients currently receiving IVIg with unacceptable adverse reactions or unable to tolerate IVIg as well as patients receiving alternate IG products via the SC route may be enrolled in this study. Patients must not be eligible for any of the Sponsor's ongoing PID studies that are still open to enrolment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Immunoglobulin G (Ig NextGen 16%) |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age >3 years of age.
- PID patients receiving Ig replacement therapy.
- 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.
- Patient is capable of self-administering Ig NextGen 16%
Key exclusion criteria (7 listed)
- Patients eligible for CSLCT-SCIG-05-23 if still open for recruitment.
- Patients with known anaphylaxis reactions to immunoglobulin therapy.
- Patients with known selective IgA deficiency or antibodies to IgA with a history of reactions to Ig therapy.
- Patients with protein-losing enteropathies.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunoglobulin G (Ig NextGen 16%)Also: Ig NextGen 16%Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G | Drug | 1 |
Primary outcome
Rate, Severity and Relatedness of reported Adverse Events
Time frame: Up to Four Years
1 secondary outcome
To monitor patient IgG trough levels while receiving Ig NextGen 16%
Time frame: Up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical and Research Director study director
CSL
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immunoglobulin G (Ig NextGen 16%) in people with Primary Immune Deficiency, run by CSL Limited at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate, Severity and Relatedness of reported Adverse Events (time frame: Up to Four Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.