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

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ClinicalTrials.gov Identifier: NCT02881437
Recruitment Status : Recruiting
First Posted : August 29, 2016
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
University Hospital, Lille

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

Condition or disease Intervention/treatment Phase
Primary Immunodeficiency Drug: IgHy10 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the IgG Trough Level in Subjects With Primary Immunodeficiency Switching From Standard Subcutaneous Immunoglobulin (SCIG) to Every Other Week HyQvia
Actual Study Start Date : November 11, 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019


Arm Intervention/treatment
Experimental: 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.
Drug: IgHy10
Sub Cutaneous IgHy10 administration
Other Name: HyQvia




Primary Outcome Measures :
  1. 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 Measures :
  1. 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) ]
  2. Number of adverse reactions [ Time Frame: 6 months ]
  3. Incidence rate of adverse reactions [ Time Frame: 6 months ]
  4. Number of infection [ Time Frame: 6 months ]
  5. The Short Form (36) Health Survey [ Time Frame: at 6 months ]
    standardized test for measuring the quality of life

  6. Treatment Satisfaction Questionnaire for Medication (TSQM-9). [ Time Frame: at 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881437


Contacts
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Contact: Eric Hachulla, MD,PhD +33 320445048 eric.hachulla@chru-lille.fr
Contact: Aurélie Noullez, SC +33 320445048 aurelie.noullez@chru-lille.fr

Locations
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France
CHRU, Hôpital Claude Huriez Recruiting
Lille, France
Principal Investigator: Eric Hachulla, MD,PhD         
Hôpital de la Conception Not yet recruiting
Marseille, France, 13005
Contact: Nicolas Schleinitz, MD       nicolas.schleinitz@mail.ap-hm.fr   
CHU de Nantes - Hôtel Dieu Recruiting
Nantes, France, 44093
Contact: Mohamed HAMIDOU, MD       mohamed.hamidou@chu-nantes.fr   
Hôpital St Louis Recruiting
Paris, France, 75010
Contact: Eric Oksenhendler, MD       eric.oksenhendler@aphp.fr   
Hôpital Necker Not yet recruiting
Paris, France, 75015
Contact: Felipe SUAREZ, MD       felipe.suarez@aphp.fr   
Hôpital Haut Lévèque Recruiting
Pessac, France, 33604
Contact: Jean-Francois VIALLARD, MD       jean-francois.viallard@u-bordeaux.fr   
CHU de Strasbourg Recruiting
Strasbourg, France, 67000
Contact: Anne-Sophie Korganow, MD       Anne-Sophie.Korganow@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Lille
Shire
Investigators
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Principal Investigator: Eric Hachulla, MD, PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02881437     History of Changes
Other Study ID Numbers: 2015_31
2016-001480-36 ( EudraCT Number )
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Primary Immunodeficiency
SubCutaneous Immunoglobulins

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs