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

NCT02881437 | Completed Phase 4

• 2 other identifiers: 2015_312016-001480-36
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 7

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

Conditions

Primary Immunodeficiency

Keywords

Primary Immunodeficiency; SubCutaneous Immunoglobulins

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

• Number of adverse reactions

  6 months

• Incidence rate of adverse reactions

  6 months

• Number of infection

  6 months

• The Short Form (36) Health Survey

  at 6 months

Study Arms (1)

IgHy10 (HyQvia)

EXPERIMENTAL

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.

Drug: IgHy10

Interventions

IgHy10 DRUG

Sub Cutaneous IgHy10 administration

Also known as: HyQvia

IgHy10 (HyQvia)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suffering from PI requiring immunoglobulin replacement therapy.
• Willing and able to comply with the requirements of the protocol.
• Having signed the informed consent form.

You may not qualify if:

• 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.
• If female, pregnant or breastfeeding at the time of enrolment.
• If female, planning to become pregnant during the time period of the study.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Shire: collaborator

Study Sites (7)

CHRU, Hôpital Claude Huriez

Lille, France

Location

Hôpital de la Conception

Marseille, 13005, France

Location

CHU de Nantes - Hôtel Dieu

Nantes, 44093, France

Location

Hôpital St Louis

Paris, 75010, France

Location

Hôpital Necker

Paris, 75015, France

Location

Hôpital Haut Lévèque

Pessac, 33604, France

Location

CHU de Strasbourg

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Eric Hachulla, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 29, 2016
• Study Start: November 11, 2016
• Primary Completion: March 16, 2018
• Study Completion: November 1, 2018
• Last Updated: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)