Clinical trial NCT03668288: Tolerance and Patients' Satisfaction With IGHy
Official title: Tolerance and Patients' Satisfaction of Subcutaneous Infusion of Human Immunoglobulin Facilitated by Recombinant Human Hyaluronidase for Primary or Secondary Immunodeficiency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Secondary or Primary Immunodeficiency
Keywords: IVIG
PID
home infusion
hyaluronidase
immunoglobulin
secondary and primary immunodeficiency disease
tolerance
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients over 18 years old
* Patients with primary or secondary immunodeficiency
* Patients for whom treatment with IGHy is in place.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (IGHy)
timeFrame: Month 6
Secondary outcomes:
measure: quality of life assessed by the SF-36
timeFrame: Month 6
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: