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

NCT00751621 | Completed Phase 3 Results

• 3 other identifiers: ZLB07_002CR14722008-000830-30
• Study Type: interventional
• Target: 40
• Locations: 8 countries
• Sites: 13

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)

Keywords

Immune globulin subcutaneous; SCIG; primary immunodeficiency; PID

Outcome Measures

Primary Outcomes (1)

• Total Serum IgG Trough Levels

  The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.

  Up to 42 months

Secondary Outcomes (12)

• Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)

  Up to 42 months

• Annualized Rate of Infection Episodes

  Up to 42 months

• Number of Infection Episodes

  Up to 42 months

• Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections

  Up to 42 months

• Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections

  Up to 42 months

Study Arms (1)

IgPro20

EXPERIMENTAL

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).

Biological: IgPro20

Interventions

IgPro20 BIOLOGICAL

Also known as: IgG with Proline (IgPro), Hizentra

IgPro20

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (13)

Study Site

Paris, 75743, France

Location

Study Site

Berlin, 13353, Germany

Location

Study Site

Freiburg im Breisgau, 79095, Germany

Location

Study Site

Leipzig, 04129, Germany

Location

Study Site

Mainz, 55131, Germany

Location

Study Site

Warsaw, Poland

Location

Study Site

Cluj-Napoca, 400162, Romania

Location

Study Site

Timișoara, 300011, Romania

Location

Study Site

Barcelona, 08036, Spain

Location

Study Site

Seville, 41013, Spain

Location

Study Site

Gothenburg, 41685, Sweden

Location

Study Site

Bern, 3010, Switzerland

Location

Study Site

London, EC1A7BE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24412910 RESULT

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

Hizentra; Immunoglobulin G; Proline

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Imino Acids; Amino Acids, Cyclic; Amino Acids

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: CSL Behring

clinicaltrials@cslbehring.com

Use email contact

Study Officials

• Program Director, Clinical R&D

  CSL Behring

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 12, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 2, 2014
• Results First Posted: January 25, 2013

Record last verified: 2012-12

Locations

CH (1); SE (1); PL (1); RO (2); GB (1); FR (1); DE (4); ES (2)