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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:  EUCTR2014-003609-14-Outside-EU/EEA
Date of registration: 05/01/2015
Prospective Registration: Yes
Primary sponsor: CSL Behring
Public title: Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
Scientific title: A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency
Date of first enrolment:
Target sample size: 23
Recruitment status: NA
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003609-14
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 Rd 3052 Parkville Australia
Telephone:
Email: clinicaltrials@cslbehring.com
Affiliation:  CSL Behring
Name: Trial Registration Co-ordinator   
Address:  45 Poplar Rd 3052 Parkville Australia
Telephone:
Email: clinicaltrials@cslbehring.com
Affiliation:  CSL Behring
Key inclusion & exclusion criteria
Inclusion criteria:
- Subjects who have participated in study ZLB06_002CR and who have tolerated IgPro20 well.
- Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (=7 years at the time of obtaining informed consent), as far as possible.
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 11
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Ongoing serious bacterial infections (SBIs) (pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of the first infusion.
- Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (known total urine protein concentration >0.2 g/L or urine protein ++ by dipstick).
- Pregnancy or nursing mother.
- Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for ZLB06_002CR.
- Subjects who are planning to donate blood during the study.
- Re-entry of subjects previously participating in the current follow-up study.
- Known or suspected antibodies to the IMP, or to excipients of the IMP.


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 safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06_002CR (NCT01199705).
Primary end point(s): Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion
Secondary Objective: Not applicable.
Timepoint(s) of evaluation of this end point: 24 weeks
Secondary Outcome(s)
Secondary end point(s): - Overall Rate of AEs Per Infusion
- Number of Subjects With Newly Developing or Worsening AEs
- Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good'
- IgG Trough Level
- Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)
- Number of Infection Episodes
- 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
Timepoint(s) of evaluation of this end point: 24 weeks
Secondary ID(s)
NCT01458171
ZLB07_001CR
Source(s) of Monetary Support
CSL Behring
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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