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临床试验/NCT03668288
NCT03668288Unknown不适用

Tolerance and Patients' Satisfaction of Subcutaneous Infusion of Human Immunoglobulin Facilitated by Recombinant Human Hyaluronidase for Primary or Secondary Immunodeficiency

CHU de Reims1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年2月14日最近更新:
适应症

试验速览

阶段
不适用
发起方
CHU de Reims
入组人数
20
试验地点
1
主要终点
Continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (IGHy)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • patients refusing to participate in the study

结局指标

主要结局

Continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (IGHy)

时间窗: Month 6

Percentage of patients continuing IGHy treatment at 6 months

次要结局

  • quality of life assessed by the SF-36(Month 6)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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