Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03033745
• Date of registration: 23/01/2017
• Prospective Registration: Yes
• Primary sponsor: CSL Behring
• Public title: Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID)
• Scientific title: An Open-label Multicenter Study to Evaluate the Safety and Tolerability of Higher Infusion Parameters of Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra®) in Subjects With Primary Immunodeficiency
• Date of first enrolment: February 1, 2017
• Target sample size: 49
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03033745
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Canada, United States

Contacts

• Name: Study Physician
• Affiliation: CSL Behring

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.



Age minimum: 2 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Primary Immunodeficiency

Intervention(s)

Drug: IgPro20

Primary Outcome(s)

Percentage of Responders [Time Frame: At the end of 4 weeks for each planned infusion parameter]

Secondary Outcome(s)

Duration of Local TEAEs [Time Frame: At the end of 4 weeks for each planned infusion parameter]

Time to Onset of Local TEAEs [Time Frame: At the end of 4 weeks for each planned infusion parameter]

Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion [Time Frame: At the end of 4 weeks for each planned infusion parameter]

Rate of Local TEAEs Per Infusion [Time Frame: At the end of 4 weeks for each planned infusion parameter]

Intensity of Local TEAEs [Time Frame: At the end of 4 weeks for each planned infusion parameter]

Tolerability of Infusions [Time Frame: At the end of 4 weeks for each planned infusion parameter]

Secondary ID(s)

2016-003799-33

IgPro20_4004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03033745