Tolerability and Safety of Immune Globulin Subcutaneous Solution and rHuPH20 in Primary Immunodeficiency Diseases (PID)
Information source: Baxter Healthcare Corporation
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Immunodeficiency Diseases (PID)
Intervention: Immune Globulin Subcutaneous Solution (IGSC) (Biological)
Phase: Phase 3
Status: Recruiting
Sponsored by: Baxter Healthcare Corporation Official(s) and/or principal investigator(s):
Richard Schiff, MD, Study Director, Affiliation: Baxter Healthcare Corporation
Summary
The purpose of the study is to assess the long-term safety, tolerability, and practicability
of the subcutaneous treatment with Immune Globulin Subcutaneous (IGSC) facilitated with
recombinant human hyaluronidase (rHuPH20) in subjects with Primary Immunodeficiency Diseases
(PID) who have completed Baxter Clinical Study Protocol No. 160603
Clinical Details
Official title: Long-Term Tolerability and Safety of Immune Globulin Subcutaneous (IGSC)Solution Administered Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency Diseases
Study design: Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate the long-term tolerability and safety of IGSC given SC after an SC administration of recombinant human hyaluronidase (rHuPH20) in subjects with PID
Secondary outcome: To monitor the long-term efficacy of IGSC given subcutaneously after an administration of rHuPH20 in subjects with PID
Eligibility
Minimum age: 4 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject has completed or is about to complete Baxter Clinical Study Protocol No.
160603. Subjects who have discontinued rHuPH20 and reverted to intravenous or
subcutaneous treatment due to an anti-rHuPH20 antibody also may enroll for long-term
safety monitoring.
- Subject/caretaker has reviewed, signed and dated informed consent
- Subject is willing and able to comply with the requirements of the protocol
Exclusion Criteria:
- Subject has a serious medical condition such that the subject's safety or medical
care would be impacted by participation in Study 160902
- Subject is scheduled to participate in another non-Baxter clinical study involving an
investigational product or investigational device during the course of this study
- If female of childbearing potential, subject is pregnant or has a positive pregnancy
test and does not agree to employ adequate birth control measures for the duration of
the study
Locations and Contacts
West Coast Clinical Trials, Cypress, California 90360, United States; Not yet recruiting
Kenneth Kim, MD, Principal Investigator
University of California, Irvine, Irvine, California 92697, United States; Not yet recruiting
Sudir Gupta, MD, Principal Investigator
Children´s Hospital Los Angeles, Division of Clinical Immunology & Allergy, Los Angeles, California 90027, United States; Not yet recruiting
Joseph Church, MD, Principal Investigator
University of California, San Francisco, Department of Pediatrics, San Francisco, California 94143, United States; Not yet recruiting
Jennifer Puck, MD, Principal Investigator
IMMUNOe International Research Centers, Centennial, Colorado 80112, United States; Recruiting
Isaac Melamed, MD, Phone: 303-773-9000
Andrea Beck, Phone: 303.224.4673
Isaac Melamed, MD, Principal Investigator
Allergy Associates of the Palm Beaches, P.A., North Palm Beach, Florida 33408, United States; Recruiting
Mark Stein, MD, Phone: 561-626-4561
Kelly Farnan, Phone: 561.626.4561
Mark Stein, MD, Principal Investigator
Emory University, Emory Children´s Center, Atlanta, Georgia 30322, United States; Not yet recruiting
Lisa Kobrynski, MD, Phone: 404-727-3575
Andrew Crane, Phone: 404.727.3575
Lisa Kobrynski, MD, Principal Investigator
Allergy and Asthma Physicians, Hinsdale, Illinois 60521, United States; Not yet recruiting
G. Wendell Richmond, MD, Principal Investigator
Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York 10461, United States; Not yet recruiting
Arye Rubinstein, MD, Principal Investigator
Dallas Allergy Immunology Research, Dallas, Texas 75230, United States; Recruiting
Richard Wasserman, MD, Phone: 972-566-7788
Carrie Miller, Phone: 972.566.5473
Richard Wasserman, MD, Principal Investigator
University of Texas Medical Branch, Galveston, Texas 77555, United States; Not yet recruiting
J. Andrew Grant, MD, Principal Investigator
Additional Information
Starting date: July 2010
Last updated: August 3, 2010
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