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NCT Number: NCT02711228

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

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.

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Key information

Conditions

Primary Immune Deficiency Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Secondary Immune Deficiency

Age range

5 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Sainte-Justine, Montreal, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subcutaneous Immune Globulin (Human) (Hizentra)

Biological

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 17, 2016
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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