Tolerability and Safety of Immune Globulin Subcutaneous Solution and rHuPH20 in Primary Immunodeficiency Diseases (PID)
Information source: Baxter Healthcare Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Immunodeficiency Diseases (PID)
Intervention: Recombinant human hyaluronidase (rHuPH20) + Immune Globulin Subcutaneous Solution (IGSC) (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: Baxter Healthcare Corporation Official(s) and/or principal investigator(s):
David Gelmont, 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: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Long-term tolerability and safety of IGSC given subcutaneously after a subcutaneous administration of recombinant human hyaluronidase (rHuPH20) in subjects with PID
Secondary outcome: 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
University of California, Irvine, Irvine, California 92697, United States
Children´s Hospital Los Angeles, Division of Clinical Immunology & Allergy, Los Angeles, California 90027, United States
University of California, San Francisco, Department of Pediatrics, San Francisco, California 94143, United States
IMMUNOe International Research Centers, Centennial, Colorado 80112, United States
Allergy Associates of the Palm Beaches, P.A., North Palm Beach, Florida 33408, United States
Emory University, Emory Children´s Center, Atlanta, Georgia 30322, United States
Allergy and Asthma Physicians, Hinsdale, Illinois 60521, United States
Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York 10461, United States
Dallas Allergy Immunology Research, Dallas, Texas 75230, United States
University of Texas Medical Branch, Galveston, Texas 77555, United States
Additional Information
Starting date: July 2010
Last updated: September 15, 2014
|
