Secondary or Primary ImmunodeficiencyNCT03668288
Tolerance and Patients' Satisfaction With IGHy
An observational study of Secondary or Primary Immunodeficiency, run by CHU de Reims at 1 site in France.
Trial summary
Primary immunodeficiencies (PID) represent more than 150 diseases affecting the immune system. More than 50% of PIDs are due to a lack or an insufficiency in antibody production. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary or Primary Immunodeficiency
- What is being tested?
- Data record and questionnaires passation
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2019to 14 Aug 2021
- 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: * Patients over 18 years old * Patients with primary or secondary immunodeficiency * Patients for whom treatment with IGHy is in place.
Who may be able to join
- major (> 18 years),
- with primary or secondary immunodeficiency,
- followed in the Department of Internal Medicine, Infectious Diseases - Clinical Immunology CHU Reims.
- Benefiting from human immunoglobulin treatment facilitated by recombinant human hyaluronidase,
- agreeing to participate in the study.
Who cannot join
- patients refusing to participate in the study
- minors
Trial locations and contacts
1 site in 1 country.
Gauthier LEJEUNE contact
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Amélie SERVETTAZ, 03 26 83 27 69, aservettaz@chu-reims.fr
About this study
Official title: Tolerance and Patients' Satisfaction of Subcutaneous Infusion of Human Immunoglobulin Facilitated by Recombinant Human Hyaluronidase for Primary or Secondary Immunodeficiency
Primary immunodeficiencies (PID) represent more than 150 diseases affecting the immune system. More than 50% of PIDs are due to a lack or an insufficiency in antibody production. Some of these immunodeficiencies as well as some secondary immune deficiency with deficient antibody production (especially in hematology and oncology) are responsible for repeated and/or severe infections, requiring long-term replacement therapy with intravenous polyclonal immunoglobulin. Intravenous replacement therapy is administered every 21 or 28 days in hospital. Subcutaneous administration (weekly or bi-weekly) can be initiated for patients who cannot tolerate intravenous infusions or who have difficult venous access. However, some patients experience a decrease in quality of life with these more frequent administration at home. A new treatment is available in France since 2017, which is a subcutaneous infusion of human immunoglobulin facilitated by recombinant human hyaluronidase (IGHy), administered every 3 to 4 weeks in a single abdominal site, at home. No direct data are available in adults to evaluate tolerance and satisfaction with this treatment, but we know it is a preferred option in children and adolescents.
Read the detailed description
The objective of the study is to describe the continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (IGHy) therapy at 6 months from the start of treatment.
The secondary objectives are to evaluate the quality of life of patients treated with human immunoglobulin-assisted recombinant human hyaluronidase (IGHy) therapy.
- Conditions
- Secondary or Primary Immunodeficiency
- Being tested
- Data record and questionnaires passation
- Keywords
- IVIG, PID, home infusion, hyaluronidase, immunoglobulin, secondary and primary immunodeficiency disease, tolerance
- Medical subject headings
- Neoplasm Metastasis, Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data record and questionnaires passationOther
Data record and questionnaires passation (SF36)
| Study group | Role | What they receive |
|---|---|---|
| PID patients | Adults with primary or secondary immunodeficiency for whom human immunoglobulin-assisted recombinant human hyaluronidase treatment is initiated Receives: Other: Data record and questionnaires passation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (IGHy)
Percentage of patients continuing IGHy treatment at 6 months
Measured: Month 6
Secondary outcomes (1)
quality of life assessed by the SF-36
quality of life assessed by the SF-36. The Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2) is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start14 Feb 2019
- Primary completion14 Aug 2020 (estimated)
- Study completion14 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary or Primary ImmunodeficiencyStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668288
- Sponsor's protocol ID
- PO18123
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 4 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Patients' Satisfaction of Subcutaneous Infusion of Human Immunoglobulin Facilitated by Recombinant Human Hyaluronidase for Primary or Secondary Immunodeficiency
- ClinicalTrials.gov ID
- NCT03668288
- Acronym / sponsor ID
- PO18123
- Conditions
- Secondary or Primary Immunodeficiency
- Keywords
- IVIG, PID, home infusion, hyaluronidase, immunoglobulin, secondary and primary immunodeficiency disease, tolerance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 14 Aug 2020 (estimated)
- Study completion
- 14 Aug 2021 (estimated)
- First posted
- 12 Sep 2018 (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.
Primary immunodeficiencies (PID) represent more than 150 diseases affecting the immune system. More than 50% of PIDs are due to a lack or an insufficiency in antibody production. Some of these immunodeficiencies as well as some secondary immune deficiency with deficient antibody production (especially in hematology and oncology) are responsible for repeated and/or severe infections, requiring long-term replacement therapy with intravenous polyclonal immunoglobulin. Intravenous replacement therapy is administered every 21 or 28 days in hospital. Subcutaneous administration (weekly or bi-weekly) can be initiated for patients who cannot tolerate intravenous infusions or who have difficult venous access. However, some patients experience a decrease in quality of life with these more frequent administration at home. A new treatment is available in France since 2017, which is a subcutaneous infusion of human immunoglobulin facilitated by recombinant human hyaluronidase (IGHy), administered every 3 to 4 weeks in a single abdominal site, at home. No direct data are available in adults to evaluate tolerance and satisfaction with this treatment, but we know it is a preferred option in children and adolescents.
Detailed description
The objective of the study is to describe the continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (IGHy) therapy at 6 months from the start of treatment.
The secondary objectives are to evaluate the quality of life of patients treated with human immunoglobulin-assisted recombinant human hyaluronidase (IGHy) therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PID patients | – | Other: Data record and questionnaires passationAdults with primary or secondary immunodeficiency for whom human immunoglobulin-assisted recombinant human hyaluronidase treatment is initiated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients over 18 years old * Patients with primary or secondary immunodeficiency * Patients for whom treatment with IGHy is in place.
Key inclusion criteria (5 listed)
- major (> 18 years),
- with primary or secondary immunodeficiency,
- followed in the Department of Internal Medicine, Infectious Diseases - Clinical Immunology CHU Reims.
- Benefiting from human immunoglobulin treatment facilitated by recombinant human hyaluronidase,
- agreeing to participate in the study.
Key exclusion criteria (2 listed)
- patients refusing to participate in the study
- minors
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 |
|---|---|---|
| Data record and questionnaires passationData record and questionnaires passation (SF36) | Other | PID patients |
Primary outcome
Continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (IGHy)
Time frame: Month 6
Percentage of patients continuing IGHy treatment at 6 months
1 secondary outcome
quality of life assessed by the SF-36
Time frame: Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
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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.
Gauthier LEJEUNE contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary or Primary Immunodeficiency, run by CHU de Reims at 1 site 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amélie SERVETTAZ (03 26 83 27 69, aservettaz@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (IGHy) (time frame: Month 6). 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 4 Apr 2019.