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

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ClinicalTrials.gov Identifier: NCT02711228
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
CSL Behring

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.


Condition or disease Intervention/treatment Phase
Primary Immune Deficiency Secondary Immune Deficiency Biological: Subcutaneous Immune Globulin (Human) (Hizentra) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules
Actual Study Start Date : March 15, 2016
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Subcutaneous Immune Globulin (Human) (Hizentra)
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.
Biological: Subcutaneous Immune Globulin (Human) (Hizentra)
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.
Other Names:
  • IgPro20
  • Hizentra




Primary Outcome Measures :
  1. Annualized rate of adverse events (local and systemic) [ Time Frame: During biweekly treatment period, up to approximately 52 weeks ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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 Measures :
  1. Annualized rate of infections per patient [ Time Frame: During weekly and biweekly treatment periods, up to approximately 64 - 76 weeks ]
  2. 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. ]
  3. Health-related Quality of Life [ Time Frame: During weekly and biweekly treatment periods, up to approximately 64 - 76 weeks ]


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Ages Eligible for Study:   5 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02711228


Locations
Canada
Centre Hospitalier de l'université de Montréal
Montreal, Canada, QC H2W 1T7
CHU Sainte-Justine
Montreal, Canada, QC H3T 1C4
Sponsors and Collaborators
CSL Behring
Investigators
Principal Investigator: Elie Haddad, MD St. Justine's Hospital

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT02711228     History of Changes
Other Study ID Numbers: IgPro20_4005
2015-004977-34 ( EudraCT Number )
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs