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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:  EUCTR2014-003608-61-Outside-EU/EEA
Date of registration: 05/01/2015
Prospective Registration: Yes
Primary sponsor: CSL Behring
Public title: Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
Scientific title: A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency
Date of first enrolment:
Target sample size: 25
Recruitment status: NA
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003608-61
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:
- Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy
- Intravenous IgG (IVIG) therapy at regular 3- or 4-week intervals at a stable dose for at least 3 doses prior to signing of informed consent
- Written informed consent
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 13
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Newly diagnosed PID, i.e., subjects who have not previously received immunoglobulin replacement therapy
- Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening
- Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma
- Allergic or other severe reactions to immunoglobulins or other blood products recorded in the past 3 months or at the time of screening
- Pregnancy or nursing mother
- A positive result at screening on any of the following viral markers: human immunodeficiency virus-1 (HIV-1), HIV-2, hepatitis C virus, or hepatitis B virus
- Participation in a study with other investigational product during this study and within 3 months prior to screening
- Subjects who donated blood (200 mL within one month or 400 mL within 3 months prior to screening), or planning to donate blood during 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: The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.
Primary end point(s): IgG Trough Level
Secondary Objective: Not applicable
Timepoint(s) of evaluation of this end point: During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24
Secondary Outcome(s)
Secondary end point(s): - Number of Infection Episodes (Serious and Non-serious) by Study Period
- Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population
- Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population
- Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period
- Number of Days of Hospitalization Due to Infections by Study Period
- Duration of Use of Antibiotics for Infection Prophylaxis and Treatment
- Rate of All Adverse Events by Relatedness and Seriousness
- Rate of Mild, Moderate, or Severe Local Reactions
- Annualized Rate of Serious Bacterial Infections (SBIs), PPS and FAS Population (Other pre-specified endpoint)
Timepoint(s) of evaluation of this end point: Up to 36 weeks
Secondary ID(s)
NCT01199705
ZLB06_002CR
Source(s) of Monetary Support
CSL Behring
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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