Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study)
Information source: CSL Behring
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Immunodeficiency (PID)
Intervention: IgPro20 (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: CSL Behring Official(s) and/or principal investigator(s): Program Director, Clinical R&D, Study Director, Affiliation: CSL Behring
Summary
This study is a continuation of the study ZLB06_001CR with the objective of assessing
efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life
in patients with PID.
Clinical Details
Official title: A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (IgPro20 EU Extension Study)
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Total Serum IgG Trough Levels
Secondary outcome: Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)Annualized Rate of Infection Episodes Number of Infection Episodes Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections Annualized Rate of Hospitalization Due to Infections Number of Days of Hospitalization Due to Infections Use of Antibiotics for Infection Prophylaxis and Treatment Health Related Quality of Life (Short Form 36 Health Survey) Clinically Relevant Changes in Vital Signs From Baseline to the Completion Visit. Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit. Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion
Eligibility
Minimum age: 2 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects with primary humoral immunodeficiency, namely with a diagnosis of Common
variable immunodeficiency (CVID) as defined by the Pan-American Group for
Immunodeficiency (PAGID) and the European Society for Immunodeficiencies (ESID), or
X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID, or autosomal
recessive agammaglobulinemia who have participated in the study ZLB06_001CR and who
have tolerated IgPro well
- Written informed consent
Exclusion Criteria:
- Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined as total
urine protein concentration > 0. 2g/L)
- Other significant medical conditions that could increase the risk to the subject
- Females who are pregnant, breast feeding or planning a pregnancy during the course of
the study
- Participation in a study with an investigational medicinal product within three
months prior to enrollment, except for ZLB06_001CR
- Evidence of uncooperative attitude
- Any condition that is likely to interfere with evaluation of the IMP or satisfactory
conduct of the study
- Subjects who are employees at the investigational site, relatives or spouse of the
investigator
Locations and Contacts
Study Site, Paris 75743, France
Study Site, Berlin 13353, Germany
Study Site, Freiburg 79095, Germany
Study Site, Leipzig 04129, Germany
Study Site, Mainz 55131, Germany
Study Site, Warsaw, Poland
Study Site, Cluj-Napoca 400162, Romania
Study Site, Timisoara 300011, Romania
Study Site, Barcelona 08036, Spain
Study Site, Sevilla 41013, Spain
Study Site, Göteborg 41685, Sweden
Study Site, Bern 3010, Switzerland
Study Site, London EC1A7BE, United Kingdom
Additional Information
Click here to request more information about this study
Starting date: August 2008
Last updated: March 5, 2014
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