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

Information source: CSL Behring
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Immune Deficiency

Intervention: Human Normal Immunoglobulin for Subcutaneous Administration (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: CSL Behring

Official(s) and/or principal investigator(s):
Richard L. Wasserman, MD, PhD, Principal Investigator, Affiliation: Dallas Allergy Immunology and Medical City Children's Hospital,

Summary

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

Clinical Details

Official title: A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics 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 Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population)

Area Under the Concentration-time Curve (AUC) of Total Serum Immunoglobulin G (IgG)

Secondary outcome:

Annualized Rate of Clinically Documented SBIs (ITT Population)

Annualized Rate of Clinically Documented SBIs (PPE Population)

Annualized Rate of Infection Episodes

Number of Infection Episodes (Serious and Non-serious)

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

Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections

Annualized Rate of Hospitalization Due to Infection

Number of Days of Hospitalization Due to Infections

Use of Antibiotics for Infection Prophylaxis and Treatment

Total Serum IgG Trough Levels

Maximum Concentration (Cmax) of Total Serum IgG at Steady State

Tmax at Steady State

Detailed description: The entire study consists of a 12-week wash-in/wash-out period followed by a 12-month treatment period. Pharmacokinetic (PK) parameters were assessed in a sub-group of subjects.

Eligibility

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

Criteria:

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

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

Locations and Contacts

Study Site, Los Angeles, California 90025, United States

Study Site, Los Angeles, California 90027, United States

Study Site, Centennial, Colorado 80112, United States

Study Site, North Palm Beach, Florida 33408, United States

Study Site, Atlanta, Georgia 30322, United States

Study Site, Fort Wayne, Indiana 46815, United States

Study Site, Indianapolis, Indiana 46202, United States

Study Site, Iowa City, Iowa 52242, United States

Study Site, St.Louis, Missouri 63104-1095, United States

Study Site, Newark, New Jersey 07103, United States

Study Site, New York, New York 10029, United States

Study Site, Philadelphia, Pennsylvania 19104, United States

Study Site, Dallas, Texas 75230, United States

Additional Information

Click here to request more information about this study

Starting date: November 2006
Last updated: December 16, 2012

Page last updated: August 23, 2015

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