Tolerability and Safety of Immune Globulin Subcutaneous Solution and rHuPH20 in Primary Immunodeficiency Diseases (PID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01175213
First received: August 3, 2010
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Primary Immunodeficiency Diseases (PID)
Biological: Immune Globulin Subcutaneous Solution (IGSC)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Long-term tolerability and safety of IGSC given subcutaneously after a subcutaneous administration of recombinant human hyaluronidase (rHuPH20) in subjects with PID [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Long-term efficacy of IGSC given subcutaneously after an administration of rHuPH20 in subjects with PID [ Time Frame: 21 months ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: July 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment with IGSC Biological: Immune Globulin Subcutaneous Solution (IGSC)
Subjects will continue on the same doses of IGSC, adjusted for body weight, and rHuPH20 that were used for the last infusions in Study epoch 2 of Study 160603.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175213

Locations
United States, California
West Coast Clinical Trials
Cypress, California, United States, 90360
University of California, Irvine
Irvine, California, United States, 92697
Children´s Hospital Los Angeles, Division of Clinical Immunology & Allergy
Los Angeles, California, United States, 90027
University of California, San Francisco, Department of Pediatrics
San Francisco, California, United States, 94143
United States, Colorado
IMMUNOe International Research Centers
Centennial, Colorado, United States, 80112
United States, Florida
Allergy Associates of the Palm Beaches, P.A.
North Palm Beach, Florida, United States, 33408
United States, Georgia
Emory University, Emory Children´s Center
Atlanta, Georgia, United States, 30322
United States, Illinois
Allergy and Asthma Physicians
Hinsdale, Illinois, United States, 60521
United States, New York
Montefiore Medical Center, Albert Einstein College of Medicine
Bronx, New York, United States, 10461
United States, Texas
Dallas Allergy Immunology Research
Dallas, Texas, United States, 75230
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Richard Schiff, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01175213     History of Changes
Other Study ID Numbers: 160902
Study First Received: August 3, 2010
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Antibodies
Immunoglobulins
Pharmaceutical Solutions
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014