Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)

Condition(s) targeted: Primary Immune Deficiency

Intervention: IgPro20 (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: CSL Behring

Official(s) and/or principal investigator(s):
Program Director, Study Director, Affiliation: CSL Behring

The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.

Official title: A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (PID)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population)

Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population)

Secondary outcome:

Annualized Rate of Any Infection

Trough Levels of Total Immunoglobulin G (IgG) Serum Concentrations

Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection

Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection

Number of Days of Hospitalization Due to Infection

Annualized Rate of Hospitalization Due to Infection

Use of Antibiotics for Infection Prophylaxis and Treatment

Rate of All AEs by Relatedness and Severity

Relatedness and Severity of All AEs (Percentage of Total AEs)

Number of Subjects With Any Temporally Associated Adverse Event (AE) Within 24 or 72 Hours After an Infusion

Rate of Temporally Associated AEs Within 24 or 72 Hours of an Infusion

Number of Subjects Reporting Mild, Moderate, or Severe Local AEs

Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Vital Signs

Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Routine Laboratory Parameters

Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Viral Safety Markers

Minimum age: 2 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects with primary humoral immunodeficiency who have participated in the study

ZLB04_009CR (NCT00419341), namely with a diagnosis of Common Variable Immunodeficiency (CVID) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or X-linked Agammaglobulinemia (XLA) as defined by PAGID and ESID

- Women of childbearing potential must be using and agree to continue using medically

approved contraception and must have a negative pregnancy test at screening

- Written informed consent

Exclusion Criteria:

- 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

- Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total

urine protein concentration > 0. 2 g/L)

- Other significant medical conditions that could increase the risk to the patient

- Females who are pregnant, breast-feeding or planning a pregnancy during the course of

the study

- A positive result at screening on any of the following viral markers: Human

immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis B virus (HBV)

- Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration >

2. 5 times Upper Normal Limit (UNL) at Completion Visit of study ZLB04_009CR (NCT00419341)

- Creatinine concentration > 1. 5 times UNL at Completion Visit of study ZLB04_009CR

(NCT00419341)

- Participation in a study with an investigational product other than IgPro20 within 3

months prior to enrollment

- Evidence of uncooperative attitude

- Any condition that is likely to interfere with evaluation of the study drug or

satisfactory conduct of the trial

- Subjects who are employees at the investigational site, relatives or spouse of the

investigator

Contact CSL Behring for facility details, Centennial, Colorado 80112, United States

Contact CSL Behring for facility details, North Palm Beach, Florida 33408, United States

Contact CSL Behring for facility details, Indianapolis, Indiana 46202, United States

Contact CSL Behring for facility details, Dallas, Texas 75230, United States

Click here to request more information about this study

Starting date: June 2008
Last updated: March 5, 2014