A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006522-25-DE

Enrollment

Registered

2006-12-07

Start date

2007-02-01

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 Women who have become pregnant during the course of the study have to be withdrawn Participation in a study with an investigational product within 3 months prior to enrollment Known or suspected HIV infection, acute hepatitis or clinically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

Design outcomes

Primary

Measure	Time frame
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: ;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.	—

Measure

Time frame

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: ;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.

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Countries

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

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026