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

Primary Purpose

Primary Immunodeficiency

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
IgHy10
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immunodeficiency focused on measuring Primary Immunodeficiency, SubCutaneous Immunoglobulins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHRU, Hôpital Claude Huriez
  • Hôpital de la Conception
  • CHU de Nantes - Hôtel Dieu
  • Hôpital St Louis
  • Hôpital Necker
  • Hôpital Haut Lévèque
  • CHU de Strasbourg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IgHy10 (HyQvia)

Arm 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 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.

Outcomes

Primary Outcome Measures

The primary endpoint is the change in IgG trough level at 3 months (visit 3) as compared to baseline (visit 1).

Secondary Outcome Measures

The change in IgG trough level at 6 months (visit 4) as compared to baseline (visit 1) and 3 months (visit 3).
Number of adverse reactions
Incidence rate of adverse reactions
Number of infection
The Short Form (36) Health Survey
standardized test for measuring the quality of life
Treatment Satisfaction Questionnaire for Medication (TSQM-9).

Full Information

First Posted
August 17, 2016
Last Updated
June 24, 2019
Sponsor
University Hospital, Lille
Collaborators
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT02881437
Brief Title
IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQvia
Official Title
Assessment of the IgG Trough Level in Subjects With Primary Immunodeficiency Switching From Standard Subcutaneous Immunoglobulin (SCIG) to Every Other Week HyQvia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 11, 2016 (Actual)
Primary Completion Date
March 16, 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Shire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immunodeficiency
Keywords
Primary Immunodeficiency, SubCutaneous Immunoglobulins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IgHy10 (HyQvia)
Arm Type
Experimental
Arm 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 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.
Intervention Type
Drug
Intervention Name(s)
IgHy10
Other Intervention Name(s)
HyQvia
Intervention Description
Sub Cutaneous IgHy10 administration
Primary Outcome Measure Information:
Title
The primary endpoint is the change in IgG trough level at 3 months (visit 3) as compared to baseline (visit 1).
Time Frame
Every 2 weeks during the baseline (visit 1) and the 3 months (visit3)
Secondary Outcome Measure Information:
Title
The change in IgG trough level at 6 months (visit 4) as compared to baseline (visit 1) and 3 months (visit 3).
Time Frame
Every 3 weeks after the 3 months (visit 3) as 6 months ( visit 4)
Title
Number of adverse reactions
Time Frame
6 months
Title
Incidence rate of adverse reactions
Time Frame
6 months
Title
Number of infection
Time Frame
6 months
Title
The Short Form (36) Health Survey
Description
standardized test for measuring the quality of life
Time Frame
at 6 months
Title
Treatment Satisfaction Questionnaire for Medication (TSQM-9).
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Hachulla, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU, Hôpital Claude Huriez
City
Lille
Country
France
Facility Name
Hôpital de la Conception
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
CHU de Nantes - Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital St Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Haut Lévèque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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