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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


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).


Minimum age: 2 Years. Maximum age: 65 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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