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

NCT ID: NCT00751621

Last Updated: 2014-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-12-31

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.

Conditions

Primary Immunodeficiency (PID)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IgPro20

Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).

Group Type: EXPERIMENTAL

IgPro20

Intervention Type: BIOLOGICAL

Interventions

IgPro20

Intervention Type: BIOLOGICAL

Other Intervention Names

IgG with Proline (IgPro); Hizentra

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Program Director, Clinical R&D

Role: STUDY_DIRECTOR

CSL Behring

Locations

Study Site

Paris, , France

Study Site

Berlin, , Germany

Study Site

Freiburg im Breisgau, , Germany

Study Site

Leipzig, , Germany

Study Site

Mainz, , Germany

Study Site

Warsaw, , Poland

Study Site

Cluj-Napoca, , Romania

Study Site

Timișoara, , Romania

Study Site

Barcelona, , Spain

Study Site

Seville, , Spain

Study Site

Gothenburg, , Sweden

Study Site

Bern, , Switzerland

Study Site

London, , United Kingdom

Countries

France; Germany; Poland; Romania; Spain; Sweden; Switzerland; United Kingdom

References

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.

Reference Type: RESULT

PMID: 24412910 (View on PubMed)

Other Identifiers

1472

Identifier Type: OTHER

Identifier Source: secondary_id

2008-000830-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ZLB07_002CR

Identifier Type: -

Identifier Source: org_study_id