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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: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00520494
Date of registration: 23/08/2007
Prospective Registration: Yes
Primary sponsor: CSL Behring
Public title: Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency
Scientific title: A Multicenter Study on the Efficacy and Safety of Vivaglobin® in Previously Untreated Patients (PUPs) With Primary Immunodeficiency (PID)
Date of first enrolment: March 2007
Target sample size: 18
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00520494
Study type:  Interventional
Study design:   
Phase:  Phase 4
Countries of recruitment
Belgium Canada Germany Italy Spain
Contacts
Name:     Michael Borte, MD
Address: 
Telephone:
Email:
Affiliation:  Klinik für Kinder-und Jugendmedizin am Städtischen Klinikum St. Georg, Leipzig, Germany
Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Written informed consent, age-adapted

- Male or female aged 1 to 70 years

- Diagnosis of primary humoral immunodeficiency

- No prior immunoglobulin substitution therapy

- IgG level of <5 g/L at screening

- Women of childbearing potential must use medically approved contraception and must
have a negative urine pregnancy test at screening

Key Exclusion Criteria:

- Evidence of serious infection between screening and first treatment

- Bleeding disorders that require medical treatments

- Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a
clinically significant defect in cell mediated immunity

- Any condition likely to interfere with evaluation of the study drug or satisfactory
conduct of the trial



Age minimum: 1 Year
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Agammaglobulinemia
Common Variable Immunodeficiency
Intervention(s)
Drug: Vivaglobin
Primary Outcome(s)
Proportion of Patients Achieving Immunoglobulin G (IgG) Levels = 5 g/L on Day 12 [Time Frame: On Day 12]
Secondary Outcome(s)
IgG Increase (Change From Baseline) on Day 12 [Time Frame: Baseline to Day 12]
Number of Patients With Adverse Events (AEs) by Severity and Relatedness [Time Frame: For the duration of the study, up to approximately 25 weeks]
Number of Patients With Clinically Relevant Changes in Routine Laboratory Parameters [Time Frame: At Weeks 12 and 25]
Number of Patients With Clinically Relevant Changes in Vital Signs [Time Frame: At the screening visit, before and after infusions (Days 1 to 5), and at the completion visit (Week 25)]
Number of Patients With Local Reactions by Severity and Relatedness [Time Frame: For the duration of the study, up to approximately 25 weeks]
Overall Rate of Infections [Time Frame: For the duration of the study, up to approximately 25 weeks]
Proportion of Patients Achieving IgG Levels = 5 g/L on Day 19 [Time Frame: On Day 19]
Proportion of Patients Achieving IgG Levels = 5 g/L on Day 26 [Time Frame: On Day 26]
Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age = 14 Years) [Time Frame: At study completion, approximately Week 25]
Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age = 13 Years) [Time Frame: At study completion, approximately Week 25]
Rate of AEs by Severity and Relatedness [Time Frame: For the duration of the study, up to approximately 25 weeks]
Rate of Local Reactions by Severity and Relatedness [Time Frame: For the duration of the study, up to approximately 25 weeks]
Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25 [Time Frame: At Week 25]
Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12 [Time Frame: On Day 12]
Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25 [Time Frame: At Week 25]
Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12 [Time Frame: On Day 12]
Total Serum IgG Trough Levels at Week 25 [Time Frame: At Week 25]
Total Serum IgG Trough Levels on Day 12 [Time Frame: On Day 12]
Use of Antibiotics for Infection Prophylaxis and Treatment [Time Frame: For the duration of the study, up to approximately 25 weeks]
Secondary ID(s)
1461
2006-006522-25
ZLB06_005CR
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 03/05/2013
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00520494
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