Clinical trial NCT00751621: Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Immunodeficiency (PID)
Keywords: Immune globulin subcutaneous
SCIG
primary immunodeficiency
PID
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2008-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Total Serum IgG Trough Levels
timeFrame: Up to 42 months
Secondary outcomes:
measure: Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)
timeFrame: Up to 42 months
measure: Annualized Rate of Infection Episodes
timeFrame: Up to 42 months
measure: Number of Infection Episodes
timeFrame: Up to 42 months
measure: Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections
timeFrame: Up to 42 months
measure: Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections
timeFrame: Up to 42 months
measure: Annualized Rate of Hospitalization Due to Infections
timeFrame: Up to 42 months
measure: Number of Days of Hospitalization Due to Infections
timeFrame: Up to 42 months
measure: Use of Antibiotics for Infection Prophylaxis and Treatment
timeFrame: Up to 42 months
measure: Health Related Quality of Life (Short Form 36 Health Survey)
timeFrame: At baseline and at the last available post-baseline observation for each subject (up to 42 months)
measure: Clinically Relevant Changes in Vital Signs From Baseline to the Completion Visit.
timeFrame: At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).
measure: Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit.
timeFrame: At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).
measure: Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion
timeFrame: Up to 42 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Study Site
city: Berlin
country: Germany
facility: Study Site
city: Freiburg
country: Germany
facility: Study Site
city: Leipzig
country: Germany
facility: Study Site
city: Mainz
country: Germany
facility: Study Site
city: Warsaw
country: Poland
facility: Study Site
city: Cluj-Napoca
country: Romania
facility: Study Site
city: Timisoara
country: Romania
facility: Study Site
city: Barcelona
country: Spain
facility: Study Site
city: Sevilla
country: Spain
facility: Study Site
city: Göteborg
country: Sweden
facility: Study Site
city: Bern
country: Switzerland
facility: Study Site
city: London
country: United Kingdom
facility: Study Site
Study officials:
affiliation: CSL Behring
name: Program Director, Clinical R&D
role: STUDY_DIRECTOR
References:
citation: Jolles S, Borte M, Nelson RP Jr, Rojavin M, Bexon M, Lawo JP, Wasserman RL. Long-term efficacy, safety, and tolerability of Hizentra(R) for treatment of primary immunodeficiency disease. Clin Immunol. 2014 Feb;150(2):161-9. doi: 10.1016/j.clim.2013.10.008. Epub 2013 Oct 26.