Primary Immunodeficiency (PID)

Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study)

NCT00751621 | PHASE 3 | INTERVENTIONAL

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.

13 Sites

40 Participants

Recruiting

2 Years to 65 Years

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Find closest sites:

SUBMIT

Study Site

Paris,France,75743

Study Site

Berlin,Germany,13353

Study Site

Freiburg,Germany,79095

Study Site

Leipzig,Germany,04129

Study Site

Mainz,Germany,55131

Study Site

Warsaw,Poland

Study Site

Cluj-Napoca,Romania,400162

Study Site

Timisoara,Romania,300011

Study Site

Barcelona,Spain,08036

Study Site

Sevilla,Spain,41013

Study Site

Göteborg,Sweden,41685

Study Site

Bern,Switzerland,3010

Study Site

London,United Kingdom,EC1A7BE

Study Eligibility 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

Additional Studies

Additional studies can be found at ClinicalTrials.gov