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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

ChildrenĀ“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 ChildrenĀ“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

Page last updated: August 23, 2015

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