Tolerance and Patients' Satisfaction With IGHy

Last updated: April 3, 2019
Sponsor: CHU de Reims
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv Infections

Neoplasm Metastasis

Treatment

N/A

Clinical Study ID

NCT03668288
PO18123
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • major (> 18 years),

  • with primary or secondary immunodeficiency,

  • followed in the Department of Internal Medicine, Infectious Diseases - ClinicalImmunology CHU Reims.

  • Benefiting from human immunoglobulin treatment facilitated by recombinant humanhyaluronidase,

  • agreeing to participate in the study.

Exclusion

Exclusion Criteria:

  • patients refusing to participate in the study

  • minors

Study Design

Total Participants: 20
Study Start date:
February 14, 2019
Estimated Completion Date:
August 14, 2021

Study 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.

Connect with a study center

  • Damien JOLLY

    Reims,
    France

    Active - Recruiting

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