Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy
Information source: CSL Behring
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Common Variable Immunodeficiency; X-linked Agammaglobulinemia; Autosomal Recessive Agammaglobulinemia
Intervention: Human Normal Immunoglobulin for Subcutaneous Administration (IGSC) (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: CSL Behring Official(s) and/or principal investigator(s): Stephen Jolles, MD, Principal Investigator, Affiliation: University Hospital of Wales, Cardiff, UK
Summary
The objective of this study is to assess the efficacy, tolerability, safety and
pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
Clinical Details
Official title: A Multicentre Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency
Study design: Allocation: Non-Randomized, 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: Annual Rate of Clinically Documented Serious Bacterial Infections (ITT Population)Annual Rate of Clinically Documented Serious Bacterial Infections (PPE Population) Annual Rate of Infection Episodes Annual Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections Annual Rate of the Number of Days of Hospitalization Due to Infections Annual Rate of Antibiotic Use for Infection Prophylaxis and Treatment
Detailed description:
This study consisted of a 12-week wash-in/wash-out period followed by a 28-week efficacy
period. During the 28-week efficacy period, subjects visited the study site at least every 4
weeks for efficacy and safety evaluations and additionally recorded details regarding
IgPro20 dose and certain aspects of efficacy and safety in a diary. Pharmacokinetic (PK)
parameters were assessed in a sub-group of subjects during 1 treatment interval at
steady-state (Week 28 ± 1).
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 European Society for Immunodeficiencies (ESID), X-linked
agammaglobulinemia (XLA) as defined by PAGID and ESID, or Autosomal Recessive
Agammaglobulinemia
- Chest X-ray or CT scan obtained within 1 year prior to enrolment
Exclusion Criteria:
- Newly diagnosed PID, i. e. subjects who have not previously received immunoglobulin
replacement therapy
- Ongoing serious bacterial infection at the time of screening
- Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma
and immunodeficiency with thymoma
- Allergic or other severe reactions to immunoglobulins or other blood products
associated with high anti-IgA
Additional criteria may apply and examination by an investigator is required to determine
eligibility.
Locations and Contacts
Study site, Paris 75743, France
Study site, Berlin 13353, Germany
Study site, Düsseldorf 40001, Germany
Study site, Freiburg 79095, Germany
Study site, Hannover 30625, Germany
Study site, Leipzig 04129, Germany
Study site, Mainz 55131, Germany
Study site, Munich 80337, Germany
Study site, Brescia 25123, Italy
Study site, Warsaw 04-736, Poland
Study site, Bucharest 020393, Romania
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, Berne 3010, Switzerland
Study site, Cardiff CF 14 4XW, United Kingdom
Study site, London NW3 2QG, United Kingdom
Additional Information
Click here to request more information about this study
Starting date: September 2007
Last updated: August 2, 2011
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