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Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules

Primary Purpose

Primary Immune Deficiency, Secondary Immune Deficiency

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Subcutaneous Immune Globulin (Human) (Hizentra)
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Primary Immune Deficiency

Eligibility Criteria

5 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Full study:

  • Female or male patients with primary or secondary immunodeficiency, aged from 5 to 64 years, receiving steady state immunoglobulin G replacement therapy.

Pharmacokinetic sub-study:

  • Female or male patients with primary immunodeficiency, aged between 12 and 64 years of age, on steady-state IgPro20 replacement therapy and willing to undergo pharmacokinetic sample collection on weekly and biweekly IgPro20 dosing regimens.

Exclusion Criteria:

  • Patients with protein losing conditions such as: lymphangiectasis, nephrosis, status post cardio-thoracic surgery requiring drainage tubes for more than 48 hours, protein-losing enteropathy.
  • Concomitant treatment with plasma or other blood products (including any IgGs other than IgPro20 [Hizentra]) within 21 days before study entry and/or during the study.
  • Any other condition or treatment that, in the opinion of the investigator, would interfere with obtaining valid results for that subject.
  • Women of childbearing potential with a positive pregnancy test.
  • Active infection at the time of screening.

Sites / Locations

  • Centre Hospitalier de l'université de Montréal
  • CHU Sainte-Justine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subcutaneous Immune Globulin (Human) (Hizentra)

Arm Description

Hizentra, Subcutaneous Immune Globulin (Human) (SCIg), is a ready to use, polyvalent human normal Immunoglobulin G (IgG) for subcutaneous administration. Hizentra is a 20% IgG protein solution, is prepared from large pools of human plasma, and is stabilized by L-Proline.

Outcomes

Primary Outcome Measures

Annualized rate of adverse events (local and systemic)
Area under the concentration-time curve, AUC(0-t )
Maximal serum IgG concentration (Cmax)
Time to maximal serum IgG concentration (Tmax)
Trough serum IgG concentration (Ctrough)

Secondary Outcome Measures

Annualized rate of infections per patient
Serum IgG trough levels (Ctrough)
Health-related Quality of Life

Full Information

First Posted
March 7, 2016
Last Updated
February 23, 2018
Sponsor
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT02711228
Brief Title
Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules
Official Title
Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 15, 2016 (Actual)
Primary Completion Date
January 30, 2018 (Actual)
Study Completion Date
January 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to assess the impact of immunoglobulin treatment by subcutaneous injections every 2 weeks (biweekly) on a cohort of patients with primary and secondary immune deficiencies. The full study will consist of safety, efficacy and Quality of Life (QoL) evaluations and a pharmacokinetic (PK) sub-study. The primary objectives of the study are to determine tolerability and safety of biweekly IgPro20 injection regimen and to compare PK outcomes on weekly and biweekly IgPro20 therapy. Patients who have received and/or are currently receiving immunoglobulin G (IgG) in intravenous (IVIg), or subcutaneous (SCIg) infusions are eligible for inclusion if they meet inclusion/exclusion criteria. The study consists of two parts. In Part 1 of the study enrolled subjects will receive IgPro20 weekly for either 12 weeks (for patients on SCIg infusion prior to the study) or 24 weeks (for patients on IVIg infusion prior to the study). Part 2 will consist of a biweekly treatment with IgPro20 for 52 weeks, for both groups. Additionally, study subjects meeting inclusion criteria for the PK sub-study will undergo a PK sample collection for 1 week and 2 weeks in study Parts 1 and 2, respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Deficiency, Secondary Immune Deficiency

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Subcutaneous Immune Globulin (Human) (Hizentra)
Arm Type
Experimental
Arm Description
Hizentra, Subcutaneous Immune Globulin (Human) (SCIg), is a ready to use, polyvalent human normal Immunoglobulin G (IgG) for subcutaneous administration. Hizentra is a 20% IgG protein solution, is prepared from large pools of human plasma, and is stabilized by L-Proline.
Intervention Type
Biological
Intervention Name(s)
Subcutaneous Immune Globulin (Human) (Hizentra)
Other Intervention Name(s)
IgPro20, Hizentra
Intervention Description
Hizentra, Subcutaneous Immune Globulin (Human) (SCIg), is a ready to use, polyvalent human normal Immunoglobulin G (IgG) for subcutaneous administration. Hizentra is a 20% IgG protein solution, is prepared from large pools of human plasma, and is stabilized by L-Proline.
Primary Outcome Measure Information:
Title
Annualized rate of adverse events (local and systemic)
Time Frame
During biweekly treatment period, up to approximately 52 weeks
Title
Area under the concentration-time curve, AUC(0-t )
Time Frame
Immediately before, and up to 7 days after infusion during the weekly treatment period and up to 14 days after infusion during the biweekly treatment periods.
Title
Maximal serum IgG concentration (Cmax)
Time Frame
Up to 7 days after infusion during the weekly treatment period and up to 14 days after infusion during the biweekly treatment periods.
Title
Time to maximal serum IgG concentration (Tmax)
Time Frame
Up to 7 days after infusion during the weekly treatment period and up to 14 days after infusion during the biweekly treatment periods.
Title
Trough serum IgG concentration (Ctrough)
Time Frame
Immediately before, and up to 7 days after infusion during the weekly treatment period and up to 14 days after infusion during the biweekly treatment periods.
Secondary Outcome Measure Information:
Title
Annualized rate of infections per patient
Time Frame
During weekly and biweekly treatment periods, up to approximately 64 - 76 weeks
Title
Serum IgG trough levels (Ctrough)
Time Frame
On day 7 (immediately before each next infusion) during the weekly treatment period, and on week 24 and 48 of biweekly treatment.
Title
Health-related Quality of Life
Time Frame
During weekly and biweekly treatment periods, up to approximately 64 - 76 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Full study: Female or male patients with primary or secondary immunodeficiency, aged from 5 to 64 years, receiving steady state immunoglobulin G replacement therapy. Pharmacokinetic sub-study: Female or male patients with primary immunodeficiency, aged between 12 and 64 years of age, on steady-state IgPro20 replacement therapy and willing to undergo pharmacokinetic sample collection on weekly and biweekly IgPro20 dosing regimens. Exclusion Criteria: Patients with protein losing conditions such as: lymphangiectasis, nephrosis, status post cardio-thoracic surgery requiring drainage tubes for more than 48 hours, protein-losing enteropathy. Concomitant treatment with plasma or other blood products (including any IgGs other than IgPro20 [Hizentra]) within 21 days before study entry and/or during the study. Any other condition or treatment that, in the opinion of the investigator, would interfere with obtaining valid results for that subject. Women of childbearing potential with a positive pregnancy test. Active infection at the time of screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elie Haddad, MD
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'université de Montréal
City
Montreal
ZIP/Postal Code
QC H2W 1T7
Country
Canada
Facility Name
CHU Sainte-Justine
City
Montreal
ZIP/Postal Code
QC H3T 1C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules

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