DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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


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 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


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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017