Tolerance and Patients' Satisfaction With IGHy

Sponsor
CHU de Reims (Other)
Overall Status
Unknown status
CT.gov ID
NCT03668288
Collaborator
(none)
20
1
30
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Data record and questionnaires passation

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Tolerance and Patients' Satisfaction of Subcutaneous Infusion of Human Immunoglobulin Facilitated by Recombinant Human Hyaluronidase for Primary or Secondary Immunodeficiency
Actual Study Start Date :
Feb 14, 2019
Anticipated Primary Completion Date :
Aug 14, 2020
Anticipated Study Completion Date :
Aug 14, 2021

Arms and Interventions

Arm Intervention/Treatment
PID patients

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

Other: Data record and questionnaires passation
Data record and questionnaires passation (SF36)

Outcome Measures

Primary Outcome Measures

  1. Continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (IGHy) [Month 6]

    Percentage of patients continuing IGHy treatment at 6 months

Secondary Outcome Measures

  1. quality of life assessed by the SF-36 [Month 6]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Damien JOLLY Reims France

Sponsors and Collaborators

  • CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CHU de Reims
ClinicalTrials.gov Identifier:
NCT03668288
Other Study ID Numbers:
  • PO18123
First Posted:
Sep 12, 2018
Last Update Posted:
Apr 4, 2019
Last Verified:
Sep 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by CHU de Reims
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2019