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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: 19 March 2012
Main ID:  EUCTR2006-006522-25-IT
Date of registration: 31/07/2007
Prospective Registration: Yes
Primary sponsor: CSL Behring AG
Public title: A Multicenter study on the efficacy and safety of Vivaglobin in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) - ND
Scientific title: A Multicenter study on the efficacy and safety of Vivaglobin in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) - ND
Date of first enrolment: 13/08/2007
Target sample size: 28
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006522-25
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Phase: 
Countries of recruitment
Belgium Germany Greece Italy Spain United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1.Written informed consent, age-adapted Male or female ages 1 to 70 years 2.Diagnosis of primary immunodeficiency (CVID as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) XLA) 3.No prior immunoglobulin treatment 4.IgG level of <500 mg/dL at screening 5.Women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1.Evidence of serious infection between screening and Day 1 (day of first Vivaglobin infusion) 2.Bleeding disorders that require 4.Hypoalbuminemia, protein-losing enteropathies, and nephropathy with proteinuria 5.Lymphoprolipherative disease (i.e. lymphoma) 6.Evidence for bronchiectasis 7.Known allergic reaction to blood products 8.Pregnant or breast-feeding females or females planning to become pregnant during the course of the study. Women who have become pregnant during the course of the study have to be withdrawn 9.Participation in a study with an investigational product within 3 months prior to enrollment 10.Known or suspected HIV infection, acute hepatitis or clinically active chronic hepatitis 11.ASAT or ALAT concentration > 2.5 times the UNL Creatinine concentration > 1.5 times the UNL 12.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
Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years.
MedDRA version: 6.1 Level: PT Classification code 10057863
Intervention(s)

Trade Name: Vivaglobin
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: immunglobulin (human)
Current Sponsor code: CE1200
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: The study is designed to assess the efficacy and safety of Vivaglobin in patients with PID who have not received prior immunoglobulin treatment
Primary end point(s): The primary objective of this trial is to show an increase in the total serum IgG trough level to >= 500 mg/dL on study Day 12. For that purpose the total serum IgG trough level will be measured on Day 12, i.e. 7 days after administration of the last loading dose of 100 mg/kg Vivaglobin on Day 5. The primary efficacy endpoint consists of the proportion of patients achieving IgG levels >=500 mg/dL on Day 12.
Secondary Objective: 1.IgG increase (change from baseline) on Day 12 2.Overall rate of infections 3.Total serum IgG trough levels 4.Serum concentrations of specific IgGs 5.Health-related quality of life as measured by an adapted SF-36 questionnaire (age >= 14 years) or CHQ-PF50 (age >= 13 years) 6.Use of antibiotics for infection prophylaxis and treatment
Secondary Outcome(s)
Secondary ID(s)
2006-006522-25-DE
ZLB06_005CR
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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