Primary Immunodeficiency (PID)Phase 3NCT00391131
Subcutaneous Ig NextGen 16% in PID Patients
A Phase 3 study testing IgNextGen 16% in people with Primary Immunodeficiency (PID), run by CSL Limited at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Primary Immunodeficiency (PID)
- What is being tested?
- IgNextGen 16%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Apr 2007to Oct 2009
- 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
- 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
Who cannot join
- • 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
Show all 14Show fewer
- 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.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Australia8 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Frankston Hospital
Frankston, Victoria
The Canberra Hospital
Garran, Australian Capital Territory, 2605
Royal Children's Hospital
Melbourne, Victoria, 3052
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Women's & Children's Hospital
North Adelaide, South Australia, 5006
Princess Margaret Hospital for Children
Perth, Western Australia
Sydney Children's Hospital
Randwick, New South Wales, 2031
New Zealand4 sites
Auckland Hospital
Auckland
Starship Children's Hospital
Auckland
Christchurch Hospital
Christchurch
Wellington Hospital
Wellington
About this study
Official 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).
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.
- Conditions
- Primary Immunodeficiency (PID)
- Being tested
- IgNextGen 16%
- Keywords
- PID, SCIG, Ig, Quality of Life, Serious Bacterial Infections
- 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.
IgNextGen 16%Drug
IgNextGen 16% administered subcutaneously on a weekly basis from visit 1 to 12
| Study group | Role | What they receive |
|---|---|---|
| Ig NextGen 16% | Experimental | Not described Receives: Drug: IgNextGen 16% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Measured: Continually from Visits 7 to 12 & monthly IgG troughs
Secondary outcomes (1)
Safety, Tolerability, Quality of Life, Pharmacokinetics
Measured: Visits 0, 6, 9, and12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startApr 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Immunodeficiency (PID)Studies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marianne Empson, Dr, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391131
- Sponsor's protocol ID
- CSLCT-SCIG-05-23
- Status last verified
- Jun 2012
- First submitted
- 20 Oct 2006
- Last updated
- 7 Jun 2012
- Results posted
- No
Publications
Empson MB, Tang ML, Pearce LK, Rozen L, Gold MS, Katelaris CH, Langton D, Smart J, Smith WB, Steele RH, Ziegler JB, Maher D. Efficacy, safety and pharmacokinetics of a novel subcutaneous immunoglobulin, Evogam(R), in primary immunodeficiency. J Clin Immunol. 2012 Oct;32(5):897-906. doi: 10.1007/s10875-011-9641-4. Epub 2012 Apr 13.
PubMed 22526590
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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).
- ClinicalTrials.gov ID
- NCT00391131
- Acronym / sponsor ID
- CSLCT-SCIG-05-23
- Conditions
- Primary Immunodeficiency (PID)
- Keywords
- PID, SCIG, Ig, Quality of Life, Serious Bacterial Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- CSL LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 23 Oct 2006 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ig NextGen 16% | Experimental | Drug: IgNextGen 16% |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (14 listed)
- • Patients newly diagnosed with PID within six months of the Screening visit.
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 |
|---|---|---|
| IgNextGen 16%IgNextGen 16% administered subcutaneously on a weekly basis from visit 1 to 12 | Drug | Ig NextGen 16% |
Primary outcome
Efficacy
Time frame: Continually from Visits 7 to 12 & monthly IgG troughs
1 secondary outcome
Safety, Tolerability, Quality of Life, Pharmacokinetics
Time frame: Visits 0, 6, 9, and12
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 7 Jun 2012.
- Results publication: PubMed 22526590Empson MB, Tang ML, Pearce LK, Rozen L, Gold MS, Katelaris CH, Langton D, Smart J, Smith WB, Steele RH, Ziegler JB, Maher D. Efficacy, safety and pharmacokinetics of a novel subcutaneous immunoglobulin, Evogam(R), in primary immunodeficiency. J Clin Immunol. 2012 Oct;32(5):897-906. doi: 10.1007/s10875-011-9641-4. Epub 2012 Apr 13.
Related trials for Primary Immunodeficiency (PID)
RecruitingObservational study
Studies of Disorders With Increased Susceptibility to Fungal Infections
Fungal Infections, Primary Immune Deficiencies
RecruitingObservational study
COVID-19 in PID Survey
Primary Immune Deficiency, COVID
Not yet recruitingPhase 4
A Study of TAK-664 in People With Primary Immunodeficiency Diseases Who Have Not Yet Been Treated With Immunoglobulins
Primary Immunodeficiency Diseases (PID)
RecruitingObservational study
A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency
Primary Immunodeficiency Diseases (PID)
Active, not recruitingPhase 2
A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases
Epstein-Barr Virus (EBV)-Associated Diseases, EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD)
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.
Marianne Empson, Dr principal investigator
Auckland City Hospital
12 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 IgNextGen 16% in people with Primary Immunodeficiency (PID), run by CSL Limited at 12 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 5 inclusion and 14 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 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Efficacy (time frame: Continually from Visits 7 to 12 & monthly IgG troughs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391131, which also lists 1 linked publication.
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 7 Jun 2012.