Assessment of the IgG trough level in subjects with primary immunodeficiency switching from standard subcutaneous immunoglobulin (SCIG) to every other week HyQvia

Phase 1

• Conditions: Primary immunodeficiencies; MedDRA version: 19.0 Level: PT Classification code 10061598 Term: Immunodeficiency System Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-001480-36-FR
• Lead Sponsor: Centre Hospitalier Régional et Universitaire de Lille

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-22
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

To be included, subjects must satisfy all the following criteria:
•Male or female subject at least 18 years old at the time inclusion.
•Suffering from PI requiring immunoglobulin replacement therapy.
•Treated with SCIG at stable dose for at least 3 months at the time of inclusion.
•Well balanced SCIG treatment according to the investigator at the time of inclusion.
•If female of childbearing potential, the subject must have a negative blood or urine pregnancy test at the time of inclusion and must agree to employ adequate birth control measures during the whole study.
•Willing and able to comply with the requirements of the protocol.
•Having signed the informed consent form.
For patients who don’t want to participate in the study, the reason of their refusal will be collected if they agree to.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Subjects satisfying one or more of the following criteria should not take part in the study:
•Known history of chronic kidney disease, or glomerular filtration rate (GFR) of <60 mL/min/1.73m2 estimated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at the time of screening.
•Having received a chemotherapy or immunomodulating therapy for either malignant or chronic inflammatory disease for over 6 months.
•Receiving anticoagulant therapy.
•Having abnormal protein loss (protein losing enteropathy, nephrotic syndrome).
•Know allergy to hyaluronidase.
•Family member or employee of the investigator.
•Having participated in another interventional clinical study involving an investigational product (IP) or investigational device within 30 days prior to inclusion or scheduled to participate in another clinical study involving an another investigational product or investigational device during the course of this study.
•If female, pregnant or breastfeeding at the time of enrolment.
•If female, planning to become pregnant during the time period of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the change in IgG trough level at steady state after standard SCIG dosing and after HyQvia administered every other week at equivalent doses.;<br> Secondary Objective: •To determine the IgG trough level at steady state after HyQvia administered every 3-4 weeks at equivalent dose.<br><br> •To describe:<br> oThe safety of HyQvia,<br> oThe tolerability of HyQvia,<br> oThe effectiveness of HyQvia,<br> oThe quality of life with standard SCIG, HyQvia every other week and HyQvia every 3-4 weeks.<br> oThe treatment satisfaction<br> oThe direct costs of treatment with HyQvia.<br> ;Primary end point(s): The primary endpoint is the change in IgG trough level at V3 as compared to V1.;Timepoint(s) of evaluation of this end point: 7 months