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
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