Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy

• Conditions: Primary Immune Deficiency; MedDRA version: 17.1Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-003607-30-Outside-EU/EEA
• Lead Sponsor: CSL Behring AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-26
• Last Update Posted: 2 March 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

- Male or female aged 2 to 75 years
- Subjects with primary humoral immunodeficiency, namely with a diagnosis of: CVID (Common Variable Immunodeficiency) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or XLA (X-linked Agammaglobulinemia)
- Written informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 17
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

- Newly diagnosed PID
- Evidence of an active serious infection at the time of screening (i.e., but not limited to: bacteremia/septicemia, pneumonia, fungal osteomyelitis)
- Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma and immunodeficiency with thymoma
- Known hyperprolinemia
- Hypoalbuminemia, protein-losing enteropathies, and any proteinuria
- Allergic reactions to immunoglobulins or other blood products
- Known antibodies to Immunoglobulin A (IgA)
- The subject is receiving steroids (oral and parenteral, daily = 0.15 mg of prednisone equivalent/kg/day) or other systemic immunosuppressants
- Female who is pregnant, breast feeding or planning a pregnancy during the course of the study
- Participation in a study with an investigational product other than (IVIG) within 1 month prior to enrollment
- A positive result at screening on any of the following viral markers: Human Immunodeficiency Virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV)
- Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration > 2.5 times the upper normal limit (UNL)
- Creatinine concentration > 1.5 times the UNL
- Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).;Secondary Objective: Pharmacokinetic (PK) parameters were assessed in a sub-group of subjects.;Primary end point(s): 1. Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population)<br>2. Area Under the Concentration-time Curve (AUC) of Total Serum Immunoglobulin G (IgG)<br>;Timepoint(s) of evaluation of this end point: 1. Efficacy period: up to 12 months (week 13 to the completion visit) <br>2. Measured during a single dosing interval after at least 12 weeks of stable subcutaneous (SC) dosing with IgPro20 treatment