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Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency

NCT00520494 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-06-20

Study results available
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Summary

The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG therapy.

Conditions

  • Common Variable Immunodeficiency
  • Agammaglobulinemia

Interventions

DRUG

Vivaglobin

Human normal immunoglobulin G (IgG) for subcutaneous (SC) use.

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Michael Borte, MD · Klinik für Kinder-und Jugendmedizin am Städtischen Klinikum St. Georg, Leipzig, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • Canada
  • Germany
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00520494 on ClinicalTrials.gov