Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy

NCT ID: NCT00542997

Last Updated: 2011-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-08-31

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).

Detailed Description

This study consisted of a 12-week wash-in/wash-out period followed by a 28-week efficacy period. During the 28-week efficacy period, subjects visited the study site at least every 4 weeks for efficacy and safety evaluations and additionally recorded details regarding IgPro20 dose and certain aspects of efficacy and safety in a diary. Pharmacokinetic (PK) parameters were assessed in a sub-group of subjects during 1 treatment interval at steady-state (Week 28 ± 1).

Conditions

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

Study Design

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

Study Groups

IgPro20

Group Type: EXPERIMENTAL

Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)

Intervention Type: 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.

Interventions

Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Hizentra; SCIG

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 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

Exclusion Criteria

• 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.

• 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

CSL Behring

Principal Investigators

Stephen Jolles, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Wales, Cardiff, UK

Locations

Study site

Paris, , France

Study site

Berlin, , Germany

Study site

Düsseldorf, , Germany

Study site

Freiburg im Breisgau, , Germany

Study site

Hanover, , Germany

Study site

Leipzig, , Germany

Study site

Mainz, , Germany

Study site

Munich, , Germany

Study site

Brescia, , Italy

Study site

Warsaw, , Poland

Study site

Bucharest, , Romania

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

Cardiff, , United Kingdom

Study site

London, , United Kingdom

Countries

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

References

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.

Reference Type: RESULT

PMID: 21705277 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21674136 (View on PubMed)

Other Identifiers

ZLB06_001CR

Identifier Type: OTHER

Identifier Source: secondary_id

1460

Identifier Type: -

Identifier Source: org_study_id