Tolerance and Patients' Satisfaction With IGHy

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

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.

Study Overview

• Status: Unknown
• Conditions: Secondary or Primary Immunodeficiency
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• France
  • Reims, France
    • Recruiting
    • Damien JOLLY
    • Contact: Amélie SERVETTAZ; Phone Number: 03 26 83 27 69; Email: aservettaz@chu-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (IGHy)	Percentage of patients continuing IGHy treatment at 6 months	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life assessed by the SF-36	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	Month 6

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Anticipated): August 14, 2020
• Study Completion (Anticipated): August 14, 2021

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: PID; IVIG; tolerance; immunoglobulin; hyaluronidase; home infusion; secondary and primary immunodeficiency disease
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms; Genetic Diseases, Inborn; Neoplastic Processes; Neoplasm Metastasis; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases
• Other Study ID Numbers: PO18123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No