Primary Immune DeficiencyPhase 4NCT02711228
Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules
A Phase 4 study testing Subcutaneous Immune Globulin (Human) (Hizentra) in people with Primary Immune Deficiency and Secondary Immune Deficiency, run by CSL Behring at 2 sites in Canada.
Trial summary
The purpose of the study is to assess the impact of immunoglobulin treatment by subcutaneous injections every 2 weeks (biweekly) on a cohort of patients with primary and secondary immune deficiencies. Read more about this study
- Who is it for?
- Ages 5 to 64 years
- Conditions the study is for
- Primary Immune Deficiency, Secondary Immune Deficiency
- What is being tested?
- Subcutaneous Immune Globulin (Human) (Hizentra)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Mar 2016to 30 Jan 2018
- Phase
- Phase 4
- 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 5 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Full study:
- Female or male patients with primary or secondary immunodeficiency, aged from 5 to 64 years, receiving steady state immunoglobulin G replacement therapy.
- Pharmacokinetic sub-study:
- Female or male patients with primary immunodeficiency, aged between 12 and 64 years of age, on steady-state IgPro20 replacement therapy and willing to undergo pharmacokinetic sample collection on weekly and biweekly IgPro20 dosing regimens.
Who cannot join
- Patients with protein losing conditions such as: lymphangiectasis, nephrosis, status post cardio-thoracic surgery requiring drainage tubes for more than 48 hours, protein-losing enteropathy.
- Concomitant treatment with plasma or other blood products (including any IgGs other than IgPro20 [Hizentra]) within 21 days before study entry and/or during the study.
- Any other condition or treatment that, in the opinion of the investigator, would interfere with obtaining valid results for that subject.
- Women of childbearing potential with a positive pregnancy test.
- Active infection at the time of screening.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Centre Hospitalier de l'université de Montréal
Montreal, QC H2W 1T7
CHU Sainte-Justine
Montreal, QC H3T 1C4
About this study
The purpose of the study is to assess the impact of immunoglobulin treatment by subcutaneous injections every 2 weeks (biweekly) on a cohort of patients with primary and secondary immune deficiencies. The full study will consist of safety, efficacy and Quality of Life (QoL) evaluations and a pharmacokinetic (PK) sub-study. The primary objectives of the study are to determine tolerability and safety of biweekly IgPro20 injection regimen and to compare PK outcomes on weekly and biweekly IgPro20 therapy.
Patients who have received and/or are currently receiving immunoglobulin G (IgG) in intravenous (IVIg), or subcutaneous (SCIg) infusions are eligible for inclusion if they meet inclusion/exclusion criteria.
Read more
The study consists of two parts. In Part 1 of the study enrolled subjects will receive IgPro20 weekly for either 12 weeks (for patients on SCIg infusion prior to the study) or 24 weeks (for patients on IVIg infusion prior to the study). Part 2 will consist of a biweekly treatment with IgPro20 for 52 weeks, for both groups.
Additionally, study subjects meeting inclusion criteria for the PK sub-study will undergo a PK sample collection for 1 week and 2 weeks in study Parts 1 and 2, respectively.
- Being tested
- Subcutaneous Immune Globulin (Human) (Hizentra)
- 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.
Subcutaneous Immune Globulin (Human) (Hizentra)Biological
Also called IgPro20, Hizentra
Hizentra, Subcutaneous Immune Globulin (Human) (SCIg), is a ready to use, polyvalent human normal Immunoglobulin G (IgG) for subcutaneous administration. Hizentra is a 20% IgG protein solution, is prepared from large pools of human plasma, and is stabilized by L-Proline.
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous Immune Globulin (Human) (Hizentra) | Experimental | Hizentra, Subcutaneous Immune Globulin (Human) (SCIg), is a ready to use, polyvalent human normal Immunoglobulin G (IgG) for subcutaneous administration. Hizentra is a 20% IgG protein solution, is prepared from large pools of human plasma, and is stabilized by L-Proline. Receives: Biological: Subcutaneous Immune Globulin (Human) (Hizentra) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of adverse events (local and systemic)
Measured: During biweekly treatment period, up to approximately 52 weeks
Area under the concentration-time curve, AUC(0-t )
Measured: Immediately before, and up to 7 days after infusion during the weekly treatment period and up to 14 days after infusion during the biweekly treatment periods.
Maximal serum IgG concentration (Cmax)
Measured: Up to 7 days after infusion during the weekly treatment period and up to 14 days after infusion during the biweekly treatment periods.
Time to maximal serum IgG concentration (Tmax)
Measured: Up to 7 days after infusion during the weekly treatment period and up to 14 days after infusion during the biweekly treatment periods.
Trough serum IgG concentration (Ctrough)
Measured: Immediately before, and up to 7 days after infusion during the weekly treatment period and up to 14 days after infusion during the biweekly treatment periods.
Secondary outcomes (3)
Annualized rate of infections per patient
Measured: During weekly and biweekly treatment periods, up to approximately 64 - 76 weeks
Serum IgG trough levels (Ctrough)
Measured: On day 7 (immediately before each next infusion) during the weekly treatment period, and on week 24 and 48 of biweekly treatment.
Health-related Quality of Life
Measured: During weekly and biweekly treatment periods, up to approximately 64 - 76 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study start15 Mar 2016
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
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.
- More trials run by CSL BehringThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elie Haddad, MD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711228
- Sponsor's protocol ID
- IgPro20_4005
- Other IDs
- 2015-004977-34, 2015
- Status last verified
- Feb 2018
- First submitted
- 7 Mar 2016
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules
- ClinicalTrials.gov ID
- NCT02711228
- Acronym / sponsor ID
- IgPro20_4005
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 17 Mar 2016 (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 purpose of the study is to assess the impact of immunoglobulin treatment by subcutaneous injections every 2 weeks (biweekly) on a cohort of patients with primary and secondary immune deficiencies. The full study will consist of safety, efficacy and Quality of Life (QoL) evaluations and a pharmacokinetic (PK) sub-study. The primary objectives of the study are to determine tolerability and safety of biweekly IgPro20 injection regimen and to compare PK outcomes on weekly and biweekly IgPro20 therapy.
Patients who have received and/or are currently receiving immunoglobulin G (IgG) in intravenous (IVIg), or subcutaneous (SCIg) infusions are eligible for inclusion if they meet inclusion/exclusion criteria.
The study consists of two parts. In Part 1 of the study enrolled subjects will receive IgPro20 weekly for either 12 weeks (for patients on SCIg infusion prior to the study) or 24 weeks (for patients on IVIg infusion prior to the study). Part 2 will consist of a biweekly treatment with IgPro20 for 52 weeks, for both groups.
Additionally, study subjects meeting inclusion criteria for the PK sub-study will undergo a PK sample collection for 1 week and 2 weeks in study Parts 1 and 2, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous Immune Globulin (Human) (Hizentra) | Experimental | Biological: Subcutaneous Immune Globulin (Human) (Hizentra)Hizentra, Subcutaneous Immune Globulin (Human) (SCIg), is a ready to use, polyvalent human normal Immunoglobulin G (IgG) for subcutaneous administration. Hizentra is a 20% IgG protein solution, is prepared from large pools of human plasma, and is stabilized by L-Proline. |
Who may qualify
- Ages
- 5 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Female or male patients with primary or secondary immunodeficiency, aged from 5 to 64 years, receiving steady state immunoglobulin G replacement therapy.
- Female or male patients with primary immunodeficiency, aged between 12 and 64 years of age, on steady-state IgPro20 replacement therapy and willing to undergo pharmacokinetic sample collection on weekly and biweekly IgPro20 dosing regimens.
Key exclusion criteria (5 listed)
- Patients with protein losing conditions such as: lymphangiectasis, nephrosis, status post cardio-thoracic surgery requiring drainage tubes for more than 48 hours, protein-losing enteropathy.
- Concomitant treatment with plasma or other blood products (including any IgGs other than IgPro20 [Hizentra]) within 21 days before study entry and/or during the study.
- Any other condition or treatment that, in the opinion of the investigator, would interfere with obtaining valid results for that subject.
- Women of childbearing potential with a positive pregnancy test.
- Active infection at the time of screening.
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 |
|---|---|---|
| Subcutaneous Immune Globulin (Human) (Hizentra)Also: IgPro20, HizentraHizentra, Subcutaneous Immune Globulin (Human) (SCIg), is a ready to use, polyvalent human normal Immunoglobulin G (IgG) for subcutaneous administration. Hizentra is a 20% IgG protein solution, is prepared from large pools of human plasma, and is stabilized by L-Proline. | Biological | Subcutaneous Immune Globulin (Human) (Hizentra) |
Primary outcome
Annualized rate of adverse events (local and systemic)
Time frame: During biweekly treatment period, up to approximately 52 weeks
Area under the concentration-time curve, AUC(0-t )
Time frame: Immediately before, and up to 7 days after infusion during the weekly treatment period and up to 14 days after infusion during the biweekly treatment periods.
Maximal serum IgG concentration (Cmax)
Time frame: Up to 7 days after infusion during the weekly treatment period and up to 14 days after infusion during the biweekly treatment periods.
Time to maximal serum IgG concentration (Tmax)
Time frame: Up to 7 days after infusion during the weekly treatment period and up to 14 days after infusion during the biweekly treatment periods.
Trough serum IgG concentration (Ctrough)
Time frame: Immediately before, and up to 7 days after infusion during the weekly treatment period and up to 14 days after infusion during the biweekly treatment periods.
3 secondary outcomes
Annualized rate of infections per patient
Time frame: During weekly and biweekly treatment periods, up to approximately 64 - 76 weeks
Serum IgG trough levels (Ctrough)
Time frame: On day 7 (immediately before each next infusion) during the weekly treatment period, and on week 24 and 48 of biweekly treatment.
Health-related Quality of Life
Time frame: During weekly and biweekly treatment periods, up to approximately 64 - 76 weeks
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 26 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Elie Haddad, MD principal investigator
St. Justine's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Subcutaneous Immune Globulin (Human) (Hizentra) in people with Primary Immune Deficiency and Secondary Immune Deficiency, run by CSL Behring at 2 sites in Canada.
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 5 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 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Annualized rate of adverse events (local and systemic) (time frame: During biweekly treatment period, up to approximately 52 weeks). The study lists 5 primary outcomes in all. 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 26 Feb 2018.