Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 7, 2016
First Posted Date  ICMJE March 17, 2016
Last Update Posted Date February 26, 2018
Actual Study Start Date  ICMJE March 15, 2016
Actual Primary Completion Date January 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
  • Annualized rate of adverse events (local and systemic) [ Time Frame: During biweekly treatment period, up to approximately 52 weeks ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2016)
  • Annualized rate of adverse events (local and systemic) [ Time Frame: During biweekly treatment period, up to approximately 52 weeks ]
  • Area under the concentration-time curve, AUC(0-t ) [ Time Frame: Immediately before and up to 14 days after infusion, during weekly and biweekly treatment periods. ]
  • Maximal serum IgG concentration (Cmax) [ Time Frame: Up to 14 days after infusion, during weekly and biweekly treatment periods. ]
  • Time to maximal serum IgG concentration (Tmax) [ Time Frame: Up to 14 days after infusion, during weekly and biweekly treatment periods. ]
  • Trough serum IgG concentration (Ctrough) [ Time Frame: Immediately before and up to 14 days after infusion, during weekly and biweekly treatment periods. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2016)
  • Annualized rate of infections per patient [ Time Frame: During weekly and biweekly treatment periods, up to approximately 64 - 76 weeks ]
  • 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. ]
  • Health-related Quality of Life [ Time Frame: During weekly and biweekly treatment periods, up to approximately 64 - 76 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules
Official Title  ICMJE Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Primary Immune Deficiency
  • Secondary Immune Deficiency
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Biological: Subcutaneous Immune Globulin (Human) (Hizentra)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2016)
26
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2016)
25
Actual Study Completion Date  ICMJE January 30, 2018
Actual Primary Completion Date January 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 64 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02711228
Other Study ID Numbers  ICMJE IgPro20_4005
2015-004977-34 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party CSL Behring
Study Sponsor  ICMJE CSL Behring
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elie Haddad, MD St. Justine's Hospital
PRS Account CSL Behring
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP