Secondary or Primary Immunodeficiency Clinical Trial
Official title:
Tolerance and Patients' Satisfaction of Subcutaneous Infusion of Human Immunoglobulin Facilitated by Recombinant Human Hyaluronidase for Primary or Secondary Immunodeficiency
| NCT number | NCT03668288 |
| Other study ID # | PO18123 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 14, 2019 |
| Est. completion date | August 14, 2021 |
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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | August 14, 2021 |
| Est. primary completion date | August 14, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - patients refusing to participate in the study - minors |
| Country | Name | City | State |
|---|---|---|---|
| France | Damien JOLLY | Reims |
| Lead Sponsor | Collaborator |
|---|---|
| CHU de Reims |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (IGHy) | Percentage of patients continuing IGHy treatment at 6 months | Month 6 | |
| Secondary | 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 | Month 6 |