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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 6 February 2017
Main ID:  EUCTR2016-003799-33-Outside-EU/EEA
Date of registration: 30/01/2017
Prospective Registration: Yes
Primary sponsor: CSL Behring LLC
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:
Target sample size: 51
Recruitment status: NA
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003799-33
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 3  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Canada United States
Contacts
Name: Trial Registration Coordinator   
Address:  1020 First Avenue 19406 King of Prussia United States
Telephone:
Email: clinicaltrials@cslbehring.com
Affiliation:  CSL Behring LLC
Name: Trial Registration Coordinator   
Address:  1020 First Avenue 19406 King of Prussia United States
Telephone:
Email: clinicaltrials@cslbehring.com
Affiliation:  CSL Behring LLC
Key inclusion & exclusion criteria
Inclusion criteria:
1. Male or female on stable dose of IgPro20 (Hizentra) therapy. 2. 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. 3. Subjects with PID, namely 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. 4. With infusion parameters as specified below:
Pump-Assisted Flow Rate Cohort subjects only
4a. 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 study entry.
Pump-Assisted Volume Cohort subjects only
4b. Total weekly IgPro20 dose of = 50 mL (= 10 g).
4c. Experience with pump-assisted infusions of IgPro20 at tolerated volumes of 25 mL/injection site for at least 1 month prior to study entry.
Manual Push Flow Rate Cohort subjects only
4d. Experience with frequent (5-7 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 study entry. The dose (volume) per injection site should not exceed 25 mL.

Are the trial subjects under 18? yes
Number of subjects for this age range: 14
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
1. Ongoing serious bacterial infections at the time of screening. 2. Other significant medical conditions that could increase the risk to the subject. 3. Females who are pregnant, breast feeding, or planning a pregnancy during the course of the study. 4. Participation in a study with an Investigational Medicinal Product (IMP) other than IgPro20 within three months prior to enrollment.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Primary immunodeficiency
MedDRA version: 19.1 Level: PT Classification code 10064859 Term: Primary immunodeficiency syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: Hizentra
Product Name: Hizentra; human normal immunoglobulin (subcutaneous)
Product Code: IgPro20
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)
Main Objective: The primary objective of this study is to determine the responder rate at higher infusion parameters of IgPro20 under the following conditions:
• Pump-Assisted: Volume per injection site of 25 mL, 40 mL, and 50 mL;
• Pump-Assisted: Flow rate per injection site of 25 mL/h, 50 mL/h, 75 mL/h and 100 mL/h;
• Manual Push (manual infusion using syringe without a pump): Flow rate per injection site of 30 mL/h, 60 mL/h, and 120 mL/h (0.5 mL/min, 1 mL/min, and 2 mL/min, correspondingly).
Primary end point(s): Percentage of Responders
Secondary Objective: The secondary objectives of the study are:
• To evaluate the safety of pump-assisted IgPro20 infusions at higher infusion parameters (volume and flow rate).
• To evaluate the safety of manual push IgPro20 infusions.
• To evaluate the tolerability of higher infusion parameters of IgPro20
Timepoint(s) of evaluation of this end point: At the end of 4 weeks for each planned infusion volume/flow rate parameter level.
Secondary Outcome(s)
Secondary end point(s): 1. Rate of total adverse events (AEs)
2. Rate of local reactions
3. Time to onset of local reactions
4. Severity of local reactions
5. Duration of local reactions
6. Percentage of infusions experiencing no severe local reactions
Timepoint(s) of evaluation of this end point: 1-6. Up to 17 weeks
Secondary ID(s)
IgPro20_4004
Source(s) of Monetary Support
CSL Behring LLC
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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