Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy

Brief Title

Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy

Official Title

A Multicentre Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency

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).
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Total Serum IgG Trough Levels

Secondary Outcome

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

Condition

Common Variable Immunodeficiency

Intervention

Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)

Study Arms / Comparison Groups

 IgPro20
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

51

Start Date

September 2007

Completion Date

August 2009

Primary Completion Date

August 2009

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.
      

Gender

All

Ages

2 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Stephen Jolles, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00542997

Organization ID

1460

Secondary IDs

ZLB06_001CR


Study Sponsor

CSL Behring


Study Sponsor

Stephen Jolles, MD, Principal Investigator, University Hospital of Wales, Cardiff, UK


Verification Date

August 2011