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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: 12 January 2015
Main ID:  EUCTR2014-003409-13-Outside-EU/EEA
Date of registration: 05/01/2015
Prospective Registration: Yes
Primary sponsor: CSL Behring
Public title: Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects with Primary Immunodeficiency (Japan Study)
Scientific title: A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects with Primary Immunodeficiency
Date of first enrolment:
Target sample size: 22
Recruitment status: NA
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003409-13
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  
Phase: 
Countries of recruitment
Japan
Contacts
Name: Trial Registration Co-ordinator   
Address:  45 Poplar Road 3052 Parkville Australia
Telephone:
Email: clinicaltrials@cslbehring.com
Affiliation:  CSL Behring
Name: Trial Registration Co-ordinator   
Address:  45 Poplar Road 3052 Parkville Australia
Telephone:
Email: clinicaltrials@cslbehring.com
Affiliation:  CSL Behring
Key inclusion & exclusion criteria
Inclusion criteria:
- Subjects who have completed the preceding follow-up study ZLB07_001CR.
- Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (=7 years and <20 years of age at the time of obtaining informed consent), according to the competencies of the subject.
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Pregnancy or nursing mother.
- Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for study ZLB07_001CR.
- Subjects who are planning to donate blood during the study.
- Known or suspected antibodies to the IMP, or to excipients of the IMP.
- Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Primary Immune Deficiency
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: Hizentra®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: Human Normal Immunoglobulin
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)
Main Objective: To assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07_001CR
Primary end point(s): Annualized rate of infection episodes
Secondary Objective: Not applicable
Timepoint(s) of evaluation of this end point: Up to 36 months
Secondary Outcome(s)
Secondary end point(s): - Number of subjects with adverse events (AEs)
- Percentage of subjects with adverse events (AEs)
- Rate of AEs per infusion
- Annualized rate of clinically documented serious bacterial infections (SBIs)
- Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections
- Number of days of hospitalization due to infections
- Duration of use of antibiotics for infection prophylaxis and treatment
- Median serum IgG concentration
Timepoint(s) of evaluation of this end point: Up to 36 months
Secondary ID(s)
IgPro20_3006
Source(s) of Monetary Support
CSL Behring
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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