Secondary Immune DeficiencyNCT03369301
The Effect of Subcutaneous Immunoglobulin Gammanorm on the Distribution of IgG Subclasses and on Immunity of Patients With Secondary Immunodeficiency
An observational study of Secondary Immune Deficiency, run by Octapharma at 6 sites in France.
Trial summary
Patients with Myeloma or CLL with severe secondary hypogammaglobinemia and recurrent infections will be included in this study; for whom an IgSC treatment was prescribed. The IgSC prescription will be the decision of the treating physician. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Immune Deficiency
- What is being tested?
- Gammanorm and Other Subcutaneous Immunoglobulins
- Type of treatment
- Injection or infusion
- How many people
- 102 participants
- Where
- 6 sitesFrance
- Study dates
- 25 Sep 2017to 22 Nov 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every eligible patient for the selection criteria will be consecutively included in the study to avoid any selection bias.
Who may be able to join
- Adult male or female (≥18 years old), Myeloma or Chronic Lymphocytic Leukemia patients with secondary hypogammaglobinemia and recurring infections.
- Patients with indication for IgSC treatment but who have not started the treatment yet. Prior IgSC or IgIV treatment 6 months before inclusion is accepted (with a washout period of 6 months minimum).
- Patient having received all the necessary information about the study and signed an informed consent document.
Who cannot join
- Patient having initiated an IgSC treatment.
- Patient having received IgSC or IgIV treatment within 6 months prior to inclusion.
- Incapacity/Inability to attend the follow-up visits.
- Patient refusing to participate in the study.
- HIV positive patients.
- Incapacity to understand the study objective and process, to agree or to give informed consent to participate in the study.
- Pregnant or breast-feeding women
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CH William Morey Chalon-sur-Saône
Chalon-sur-Saône, 71100
CHD Vendée
La Roche-sur-Yon, 85000
CH la Rochelle - Hôpital Saint Louis
La Rochelle, 17000
CH Orléans
Orléans, 45100
CHU Bordeaux Centre François Magendie Hopital Haut -Lévêque
Pessac, 33604
CH Saint Malo
St-Malo, 35400
About this study
Official title: Effect of Subcutaneous Immunoglobulin (IgSC) Gammanorm® on the Distribution of IgG Subclasses and on the Humoral Immunity of Patients With Secondary Immunodeficiency.
Patients with Myeloma or CLL with severe secondary hypogammaglobinemia and recurrent infections will be included in this study; for whom an IgSC treatment was prescribed. The IgSC prescription will be the decision of the treating physician. Patient care and follow up will be performed according to the current clinical practice and the recommendations of HAS.
- Conditions
- Secondary Immune Deficiency
- Being tested
- Gammanorm, Other Subcutaneous Immunoglobulins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GammanormDrug
Gammanorm given per standard of care
Other Subcutaneous ImmunoglobulinsDrug
Other Subcutaneous Immunoglobulins given per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Gammanorm | Patients on Gammanorm per standard of care Receives: Drug: Gammanorm | |
| Other Subcutaneous Immunoglobulin | Patients on subcutaneous immunoglobulin treatments other than Gammanorm Receives: Drug: Other Subcutaneous Immunoglobulins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment
Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment collected as biological data including immunoglobulins (quantitative dosage and electrophoresis), lymphocytes, CD14 monocytes, polynuclear neutrophils, polynuclear basophils and dendritic cells
Measured: 12 months
Secondary outcomes (9)
Change in immune system
To analyze the change in the immune system (CD14 monocytes, polynuclear neutrophils, polynuclear basophils and dendritic cells)
Measured: 12 months
IgG levels
To analyze the IgG levels with respect to the IgSC treatment
Measured: 12 months
Lymphocytic Repertoire analyzing the evolution of the lymphocytic repertoire (CD3, CD4, CD8, CD19, CD56, and CD27).
To analyze the evolution of the lymphocytic repertoire (CD3, CD4, CD8, CD19, CD56, and CD27).
Measured: 12 months
IgSC treatment
To characterize the IgSC treatment duration and the patient management (observance, duration and reason of termination)
Measured: 12 months
Bacterial Infections
To evaluate the severe and non-severe bacterial infection rates
Measured: 12 months
Antibiotic Consumption
To evaluate the antibiotics consumption during the study
Measured: 12 months
Hospitalizations due to infections
Evaluate the hospitalization rates due to infections
Measured: 12 months
Safety of IgSCs to characterize the IgSCs safety, including the adverse events that are not considered to be related to the study treatment
To characterize the IgSCs safety, including the adverse events that are not considered to be related to the study treatment
Measured: 12 months
Predictive Factors of Recurrent Infections
To characterize potential predictive factors or markers of recurrent infections despite of the Ig treatment by collecting information about infections at follow up visits, especially bacterial infections and their respective antibiotherapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start25 Sep 2017
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Immune DeficiencyStudies of the same condition, open and under way.
- More trials run by OctapharmaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369301
- Sponsor's protocol ID
- Optinorm
- Status last verified
- Feb 2022
- First submitted
- 30 Nov 2017
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Subcutaneous Immunoglobulin (IgSC) Gammanorm® on the Distribution of IgG Subclasses and on the Humoral Immunity of Patients With Secondary Immunodeficiency.
- ClinicalTrials.gov ID
- NCT03369301
- Acronym / sponsor ID
- Optinorm
- Conditions
- Secondary Immune Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 12 Dec 2017 (actual)
- 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.
Patients with Myeloma or CLL with severe secondary hypogammaglobinemia and recurrent infections will be included in this study; for whom an IgSC treatment was prescribed. The IgSC prescription will be the decision of the treating physician. Patient care and follow up will be performed according to the current clinical practice and the recommendations of HAS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gammanorm | – | Drug: GammanormPatients on Gammanorm per standard of care |
| Other Subcutaneous Immunoglobulin | – | Drug: Other Subcutaneous ImmunoglobulinsPatients on subcutaneous immunoglobulin treatments other than Gammanorm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every eligible patient for the selection criteria will be consecutively included in the study to avoid any selection bias.
Key inclusion criteria (3 listed)
- Adult male or female (≥18 years old), Myeloma or Chronic Lymphocytic Leukemia patients with secondary hypogammaglobinemia and recurring infections.
- Patients with indication for IgSC treatment but who have not started the treatment yet. Prior IgSC or IgIV treatment 6 months before inclusion is accepted (with a washout period of 6 months minimum).
- Patient having received all the necessary information about the study and signed an informed consent document.
Key exclusion criteria (7 listed)
- Patient having initiated an IgSC treatment.
- Patient having received IgSC or IgIV treatment within 6 months prior to inclusion.
- Incapacity/Inability to attend the follow-up visits.
- Patient refusing to participate in the study.
- HIV positive patients.
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 |
|---|---|---|
| GammanormGammanorm given per standard of care | Drug | Gammanorm |
| Other Subcutaneous ImmunoglobulinsOther Subcutaneous Immunoglobulins given per standard of care | Drug | Other Subcutaneous Immunoglobulin |
Primary outcome
Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment
Time frame: 12 months
Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment collected as biological data including immunoglobulins (quantitative dosage and electrophoresis), lymphocytes, CD14 monocytes, polynuclear neutrophils, polynuclear basophils and dendritic cells
9 secondary outcomes
Change in immune system
Time frame: 12 months
IgG levels
Time frame: 12 months
Lymphocytic Repertoire analyzing the evolution of the lymphocytic repertoire (CD3, CD4, CD8, CD19, CD56, and CD27).
Time frame: 12 months
IgSC treatment
Time frame: 12 months
Bacterial Infections
Time frame: 12 months
Antibiotic Consumption
Time frame: 12 months
Hospitalizations due to infections
Time frame: 12 months
Safety of IgSCs to characterize the IgSCs safety, including the adverse events that are not considered to be related to the study treatment
Time frame: 12 months
Predictive Factors of Recurrent Infections
Time frame: 12 months
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 2 Mar 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Immune Deficiency, run by Octapharma at 6 sites in France.
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 3 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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.
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?
Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment (time frame: 12 months). 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 2 Mar 2022.