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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: 2 March 2015
Main ID:  EUCTR2014-003607-30-Outside-EU/EEA
Date of registration: 26/02/2015
Prospective Registration: Yes
Primary sponsor: CSL Behring AG
Public title: Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy
Scientific title: A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects With Primary Immunodeficiency (PID)
Date of first enrolment:
Target sample size: 49
Recruitment status: NA
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003607-30
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
United States
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:
- Male or female aged 2 to 75 years
- Subjects with primary humoral immunodeficiency, namely with a diagnosis of: CVID (Common Variable Immunodeficiency) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or XLA (X-linked Agammaglobulinemia)
- Written informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 17
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion criteria:
- Newly diagnosed PID
- Evidence of an active serious infection at the time of screening (i.e., but not limited to: bacteremia/septicemia, pneumonia, fungal osteomyelitis)
- Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma and immunodeficiency with thymoma
- Known hyperprolinemia
- Hypoalbuminemia, protein-losing enteropathies, and any proteinuria
- Allergic reactions to immunoglobulins or other blood products
- Known antibodies to Immunoglobulin A (IgA)
- The subject is receiving steroids (oral and parenteral, daily = 0.15 mg of prednisone equivalent/kg/day) or other systemic immunosuppressants
- Female who is pregnant, breast feeding or planning a pregnancy during the course of the study
- Participation in a study with an investigational product other than (IVIG) within 1 month prior to enrollment
- A positive result at screening on any of the following viral markers: Human Immunodeficiency Virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV)
- Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration > 2.5 times the upper normal limit (UNL)
- Creatinine concentration > 1.5 times the UNL
- Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Primary Immune Deficiency
MedDRA version: 17.1 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: IgPro20
Product Code: IgPro20
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, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
Primary end point(s): 1. Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population)
2. Area Under the Concentration-time Curve (AUC) of Total Serum Immunoglobulin G (IgG)
Secondary Objective: Pharmacokinetic (PK) parameters were assessed in a sub-group of subjects.
Timepoint(s) of evaluation of this end point: 1. Efficacy period: up to 12 months (week 13 to the completion visit)
2. Measured during a single dosing interval after at least 12 weeks of stable subcutaneous (SC) dosing with IgPro20 treatment
Secondary Outcome(s)
Secondary end point(s): 1. Annualized Rate of Clinically Documented SBIs (ITT Population)
2. Annualized Rate of Clinically Documented SBIs (PPE Population)
3. Annualized Rate of Infection Episodes
4. Number of Infection Episodes (Serious and Non-serious)
5. Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections
6. Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections
7. Annualized Rate of Hospitalization Due to Infection
8. Number of Days of Hospitalization Due to Infections
9. Use of Antibiotics for Infection Prophylaxis and Treatment
10. Total Serum IgG Trough Levels
11. Maximum Concentration (Cmax) of Total Serum IgG at Steady State
12. Tmax at Steady State
Timepoint(s) of evaluation of this end point: 1: For the duration of the study, up to 15 months
2- 9: Efficacy period: up to 12 months (week 13 to the completion visit)
10: Every 4 weeks, throughout the 12-month efficacy period
11,12: Week 28 ┬▒ 1 week of the treatment period
Secondary ID(s)
NCT00419341
ZLB04_009CR
Source(s) of Monetary Support
CSL Behring AG
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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