Primary Immunodeficiency Clinical Trial
Are you or your loved ones suffering from primary immunodeficiency?
You may be eligible to participate in a primary immunodeficiency clinical trial.
Are you or your loved ones suffering from primary immunodeficiency? You may be eligible to participate in a primary immunodeficiency clinical trial.
Georgia Pollens Clinical Research Centers
Active not recruiting 105 Spanish Court, Albany, GA, USA 31707
Clinical Research Center of Alabama
Active not recruiting 504 Brookwood Boulevard, Birmingham, AL, USA 35209
Levine Children's Hospital
Active not recruiting 1000 Blythe Boulevard, Charlotte, NC, USA 28203
Duke University School of Medicine
Active not recruiting Durham, NC, USA 27705
Long Island Jewish Medical Center
Active not recruiting Great Neck, NY, USA 11021
Research Solutions of Arizona
Active not recruiting Litchfield Park, AZ, USA 85340
Medical College of Wisconsin
Active not recruiting 8701 West Watertown Plank Road, Milwaukee, WI, USA 53226
Active not recruiting Montréal, Quebec, CAN H4A3J1
Icahn Medical Institute
Active not recruiting 1 Gustave L. Levy Place, New York, NY, USA 10029
Details for the study
Treatments and/or Procedures
- Male or female on stable dose of IgPro20 (Hizentra) therapy.
- Women of childbearing potential must be using and agree to continue using medically approved contraception (which must be discussed with the study doctor) and must have a negative pregnancy test at screening.
- Subjects with PID, eg, with a diagnosis of common variable immunodeficiency or X-linked agammaglobulinemia, as defined by the Pan American Group for Immune Deficiency and the European Society of Immune Deficiencies.
- With infusion parameters as specified below:
Pump-Assisted Flow Rate Cohort subjects only
- Experience with pump-assisted infusions of IgPro20 at the tolerated flow rate of 25 mL/h per injection site for at least 1 month prior to Day 1.
Pump-Assisted Volume Cohort subjects only
- Total weekly IgPro20 dose of ≥ 50 mL (≥ 10 g).
- Experience with pump-assisted infusions of IgPro20 at tolerated volumes of 25 mL/injection site for at least 1 month prior to Day 1.
Manual Push Flow Rate Cohort subjects only
- Experience with frequent (2-7 times per week) infusions of IgPro20 at the tolerated flow rate of approximately 0.5 mL/min (equivalent of 25-30 mL/h) per injection site for at least 1 month prior to Day 1. The dose (volume) per injection site should not exceed 25 mL.
- Ongoing serious bacterial infections at the time of screening.
- Other significant medical conditions that could increase the risk to the subject.
- Females who are pregnant, breast feeding, or planning a pregnancy during the course study.
- Participation in a study with an Investigational Medicinal Product (IMP) other than IgPro20 within three months prior to enrollment.