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Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy

NCT00542997 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2011-09-01

Study results available
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Summary

The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).

Conditions

  • Common Variable Immunodeficiency
  • X-linked Agammaglobulinemia
  • Autosomal Recessive Agammaglobulinemia

Interventions

BIOLOGICAL

Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)

IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. The initial weekly dose was determined based on subjects' previous treatment. Dose adjustments could be performed during the wash-in/wash-out period at the discretion of the investigator.

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Stephen Jolles, MD · University Hospital of Wales, Cardiff, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • France
  • Germany
  • Italy
  • Poland
  • Romania
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

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 NCT00542997 on ClinicalTrials.gov