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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02881437
Other study ID # 2015_31
Secondary ID 2016-001480-36
Status Completed
Phase Phase 4
First received
Last updated
Start date November 11, 2016
Est. completion date November 2018

Study information

Verified date June 2019
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Most immunodeficiencies are related to severe immunoglobulin deficiencies which require lifelong replacement therapy with immunoglobulin G (IgG) to reduce the incidence and severity of infections. IgG can be administered intravenously (IGIV) every 21 or 28 days or subcutaneously every week or every other week (IGSC) for subjects who do not tolerate IV infusions or have difficulties with venous access. No head-to-head data are available to directly compare HyQvia with conventional SCIG. However, SCIG is indicated for administration frequencies from daily up to every other week dosing while HyQvia is indicated for infusion frequencies every 2-4 weeks. This study is designed to assess the IgG trough level after switching from standard SCIG to every other week HyQvia and HyQvia every 3-4 weeks


Description:

Open-label, one arm study conducted in France in subjects with PI to IgG trough level at steady state after standard SCIG dosing and after HyQvia administered every other week and every 3-4 weeks at equivalent dose. The study will have three periods:

- The first period is a one-week ramp-up period. The first administration of HyQvia will be with a one-week dose as specified in the summary of product characteristics of HyQvia.

- During the first three-month follow-up period, HyQvia will be administered, every other week at a dose equivalent to the dose administered with the previous treatment (standard SCIG).

- At the end of this first follow-up period, the dose of HyQvia will be increased for the next infusion to reach a 3-week equivalent dose. If it this volume is well tolerated, the following dosing will be a 4-week equivalent dose. HyQvia will then be administered every 3 or 4 weeks for three months.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date November 2018
Est. primary completion date March 16, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion 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.

Exclusion Criteria:

- 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


Intervention

Drug:
IgHy10
Sub Cutaneous IgHy10 administration

Locations

Country Name City State
France CHRU, Hôpital Claude Huriez Lille
France Hôpital de la Conception Marseille
France CHU de Nantes - Hôtel Dieu Nantes
France Hôpital Necker Paris
France Hôpital St Louis Paris
France Hôpital Haut Lévèque Pessac
France CHU de Strasbourg Strasbourg

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Lille Shire

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary endpoint is the change in IgG trough level at 3 months (visit 3) as compared to baseline (visit 1). Every 2 weeks during the baseline (visit 1) and the 3 months (visit3)
Secondary The change in IgG trough level at 6 months (visit 4) as compared to baseline (visit 1) and 3 months (visit 3). Every 3 weeks after the 3 months (visit 3) as 6 months ( visit 4)
Secondary Number of adverse reactions 6 months
Secondary Incidence rate of adverse reactions 6 months
Secondary Number of infection 6 months
Secondary The Short Form (36) Health Survey standardized test for measuring the quality of life at 6 months
Secondary Treatment Satisfaction Questionnaire for Medication (TSQM-9). at 6 months
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