Tolerability and Safety of Immune Globulin Subcutaneous Solution and rHuPH20 in Primary Immunodeficiency Diseases (PID)
This study is ongoing, but not recruiting participants.
Sponsor:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01175213
First received: August 3, 2010
Last updated: March 6, 2013
Last verified: March 2013
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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:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Hyaluronidase (Human recombinant)
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | July 2015 (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
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: | March 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Immunologic Deficiency Syndromes Immune System Diseases Antibodies Immunoglobulins |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013