Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy

NCT00542997 | Completed Phase 3 Results

• 2 other identifiers: 1460ZLB06_001CR
• Study Type: interventional
• Target: 51
• Locations: 9 countries
• Sites: 19

Brief Summary

The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).

Conditions

Common Variable Immunodeficiency; X-linked Agammaglobulinemia; Autosomal Recessive Agammaglobulinemia

Keywords

Subcutaneous immune globulin; SCIG

Outcome Measures

Primary Outcomes (1)

• Total Serum IgG Trough Levels

  Total IgG trough levels for IgPro20 treatment at steady state were compared with documented trough level data for IgG treatment received prior to enrolling in the study (either subcutaneous or intravenous IgG). For this purpose, 6 consecutive IgPro20 trough values (obtained prior to infusions 12 to 17) per subject were aggregated to the subject's median value and then median values across subjects were summarised using descriptive statistics. The same procedure was applied to pre-study treatment using the 3 most recent IgG trough values ≥ 5 g/L obtained prior to the first IgPro20 infusion.

  Up to 6 months prior to first IgPro20 treatment (Pre-study treatment) and Week 12 to 17 (IgPro20 treatment)

Secondary Outcomes (6)

• Annual Rate of Clinically Documented Serious Bacterial Infections (ITT Population)

  Efficacy period: week 12 to week 40 after study start or to the completion visit

• Annual Rate of Clinically Documented Serious Bacterial Infections (PPE Population)

  Efficacy period: week 12 to week 40 after study start or to the completion visit

• Annual Rate of Infection Episodes

  Efficacy period: week 12 to week 40 after study start or to the completion visit

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

  Efficacy period: week 12 to week 40 after study start or to the completion visit

• Annual Rate of the Number of Days of Hospitalization Due to Infections

  Efficacy period: week 12 to week 40 after study start or to the completion visit

Other Outcomes (4)

• Maximum Concentration (Cmax) of Total Serum IgG

  Week 28 (±1week)

• Timepoint of Maximum Concentration (Tmax) of Total Serum IgG

  Week 28 (±1week)

• Area Under the Concentration-Time Curve (AUC_last) of Total Serum IgG

  Week 28 (±1week)

Study Arms (1)

IgPro20

EXPERIMENTAL

Biological: Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)

Interventions

Human Normal Immunoglobulin for Subcutaneous Administration (IGSC) BIOLOGICAL

IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. The initial weekly dose was determined based on subjects' previous treatment. Dose adjustments could be performed during the wash-in/wash-out period at the discretion of the investigator.

Also known as: Hizentra, SCIG

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 European Society for Immunodeficiencies (ESID), X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID, or Autosomal Recessive Agammaglobulinemia
• Chest X-ray or CT scan obtained within 1 year prior to enrolment

You may not qualify if:

• Newly diagnosed PID, i.e. subjects who have not previously received immunoglobulin replacement therapy
• Ongoing serious bacterial infection at the time of screening
• Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma and immunodeficiency with thymoma
• Allergic or other severe reactions to immunoglobulins or other blood products associated with high anti-IgA
• Additional criteria may apply and examination by an investigator is required to determine eligibility.

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (19)

Study site

Paris, 75743, France

Location

Study site

Berlin, 13353, Germany

Location

Study site

Düsseldorf, 40001, Germany

Location

Study site

Freiburg im Breisgau, 79095, Germany

Location

Study site

Hanover, 30625, Germany

Location

Study site

Leipzig, 04129, Germany

Location

Study site

Mainz, 55131, Germany

Location

Study site

Munich, 80337, Germany

Location

Study site

Brescia, 25123, Italy

Location

Study site

Warsaw, 04-736, Poland

Location

Study site

Bucharest, 020393, Romania

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

Cardiff, CF 14 4XW, United Kingdom

Location

Study site

London, NW3 2QG, United Kingdom

Location

Related Publications (2)

• Jolles S, Bernatowska E, de Gracia J, Borte M, Cristea V, Peter HH, Belohradsky BH, Wahn V, Neufang-Huber J, Zenker O, Grimbacher B. Efficacy and safety of Hizentra((R)) in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy. Clin Immunol. 2011 Oct;141(1):90-102. doi: 10.1016/j.clim.2011.06.002. Epub 2011 Jun 12.

  PMID: 21705277 RESULT

• Borte M, Pac M, Serban M, Gonzalez-Quevedo T, Grimbacher B, Jolles S, Zenker O, Neufang-Hueber J, Belohradsky B. Efficacy and safety of hizentra(R), a new 20% immunoglobulin preparation for subcutaneous administration, in pediatric patients with primary immunodeficiency. J Clin Immunol. 2011 Oct;31(5):752-61. doi: 10.1007/s10875-011-9557-z. Epub 2011 Jun 15.

  PMID: 21674136 RESULT

MeSH Terms

Conditions

Common Variable Immunodeficiency; Bruton type agammaglobulinemia; Agammaglobulinemia, non-Bruton type

Interventions

gamma-Globulins; Hizentra

Condition Hierarchy (Ancestors)

Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Program Director, Clinical R&D
• Organization: CSL Behring

clinicaltrials@cslbehring.com

Use email contact

Study Officials

• Stephen Jolles, MD

  University Hospital of Wales, Cardiff, UK

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 11, 2007
• First Posted: October 12, 2007
• Study Start: September 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: September 1, 2011
• Results First Posted: March 15, 2011

Record last verified: 2011-08

Locations

SE (1); PL (1); DE (7); ES (2); CH (1); FR (1); IT (1); RO (3); GB (2)