Tolerance and Patients' Satisfaction With IGHy

CHU de Reims

Status: Unknown

Conditions: Secondary or Primary Immunodeficiency

Treatments: Other: Data record and questionnaires passation

Study type: Observational

Funder types: Other

Identifiers

NCT03668288

PO18123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

PID patients

Description:

Adults with primary or secondary immunodeficiency for whom human immunoglobulin-assisted recombinant human hyaluronidase treatment is initiated

Treatment:

Other: Data record and questionnaires passation