IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQvia

NCT ID: NCT02881437

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-11
• Study Completion Date: 2018-11-30

Brief 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

Detailed 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.

Conditions

Primary Immunodeficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IgHy10 (HyQvia)

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 IgHy10 (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 IgHy10 (HyQvia) will be with a one-week dose
• During the first three-month follow-up period, IgHy10 (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 IgHy10 (HyQvia) will be increased for the next infusion to reach a 3-4 week equivalent dose.

Group Type: EXPERIMENTAL

IgHy10

Intervention Type: DRUG

Sub Cutaneous IgHy10 administration

Interventions

IgHy10

Sub Cutaneous IgHy10 administration

Intervention Type: DRUG

Other Intervention Names

HyQvia

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Hachulla, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

CHRU, Hôpital Claude Huriez

Lille, , France

Hôpital de la Conception

Marseille, , France

CHU de Nantes - Hôtel Dieu

Nantes, , France

Hôpital St Louis

Paris, , France

Hôpital Necker

Paris, , France

Hôpital Haut Lévèque

Pessac, , France

CHU de Strasbourg

Strasbourg, , France

Countries

France

Other Identifiers

2016-001480-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2015_31

Identifier Type: -

Identifier Source: org_study_id