Estudio multicéntrico sobre la eficacia y la seguridad de Vivaglobin® en pacientes sin tratamiento previo (PUP) con inmunodeficiencia primaria (PID) (A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID))

• Register: EUCTR
• Last refreshed on: 7 September 2021
• Main ID: EUCTR2006-006522-25-ES
• Date of registration: 03/03/2010
• Prospective Registration: No
• Primary sponsor: CSL Behring AG
• Public title: Estudio multicéntrico sobre la eficacia y la seguridad de Vivaglobin® en pacientes sin tratamiento previo (PUP) con inmunodeficiencia primaria (PID) (A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID))
• Scientific title: Estudio multicéntrico sobre la eficacia y la seguridad de Vivaglobin® en pacientes sin tratamiento previo (PUP) con inmunodeficiencia primaria (PID) (A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID))
• Date of first enrolment: 01/07/2007
• 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: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium, Germany, Greece, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Written informed consent, age-adapted· Male or female ages 1 to 70 years
Diagnosis of primary immunodeficiency o CVID as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies)o XLA
No prior immunoglobulin treatment
IgG level of <500 mg/dL at screening
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:
Evidence of serious infection between screening and Day 1 (day of first Vivaglobin infusion)
Bleeding disorders that require medical treatments (e.g. hemophilia)
Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a clinically significant defect in cell mediated immunity
Hypoalbuminemia, protein-losing enteropathies, and nephropathy with proteinuria· Lymphoprolipherative disease (i.e. lymphoma)
Evidence for bronchiectasis
Known allergic reaction to blood products
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
Participation in a study with an investigational product within 3 months prior to enrollment
Known or suspected HIV infection, acute hepatitis or clinically active chronic hepatitis
ASAT or ALAT concentration > 2.5 times the 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

Pacientes con inmunodeficiencia primaria como inmunodeficiencia variable común (CVID) o agammaglobulinemia vinculada al cromosoma X (XLA) de entre 1 y 70 años de edad. (Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years)
MedDRA version: 8.1 Level: LLT Classification code 10010112 Term: Common variable immunodeficiency

Intervention(s)

Trade Name: Vivaglobin
Product Name: Vivaglobin
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: immune globulin subcutaneous (human)
Current Sponsor code: CE1200
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-

Primary Outcome(s)

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.

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

Secondary Objective:

Secondary ID(s)

ZLB06_005CR

2006-006522-25-DE

Ethics review

Status: Approved
Approval date: 15/06/2007
Contact:

Results

• Results available: Yes
• Date Posted: 06/08/2015
• Date Completed: 31/10/2008
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-006522-25/results