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Tolerance and Patients' Satisfaction With IGHy

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ClinicalTrials.gov Identifier: NCT03668288
Recruitment Status : Unknown
Verified September 2018 by CHU de Reims.
Recruitment status was:  Recruiting
First Posted : September 12, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Study Description
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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
Secondary or Primary Immunodeficiency 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
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Study Type : Observational
Estimated 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 : February 14, 2019
Estimated Primary Completion Date : August 14, 2020
Estimated Study Completion Date : August 14, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (IGHy) [ Time Frame: Month 6 ]
    Percentage of patients continuing IGHy treatment at 6 months


Secondary Outcome Measures :
  1. quality of life assessed by the SF-36 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668288


Contacts
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Contact: Amélie SERVETTAZ 03 26 83 27 69 aservettaz@chu-reims.fr
Contact: Gauthier LEJEUNE gauthierle@gmai.com

Locations
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France
Damien JOLLY Recruiting
Reims, France
Contact: Amélie SERVETTAZ    03 26 83 27 69    aservettaz@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
More Information
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03668288    
Other Study ID Numbers: PO18123
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
IVIG
PID
home infusion
hyaluronidase
 immunoglobulin
secondary and primary immunodeficiency disease
tolerance
Additional relevant MeSH terms:
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Neoplasm Metastasis
Primary Immunodeficiency Diseases
Immunologic Deficiency Syndromes
Neoplastic Processes
 Neoplasms
Pathologic Processes
Immune System Diseases
Genetic Diseases, Inborn