Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID

Completed · Phase 3

Conditions studied: Primary Immunodeficiency Diseases (PID)

In brief

The original purpose of the study is to assess the long-term safety, tolerability, and practicability of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous Solution (IGSC), 10% facilitated with recombinant human hyaluronidase (rHuPH20) in participants with Primary Immunodeficiency Diseases (PID) who have completed Baxter Clinical Study Protocol No. 160603. Following a discussion with the FDA, all participants still active in the study stopped treatment with rHuPH20 to assure safety of the participants participating in the study and went into a safety follow-up. During this safety follow-up period, participants underwent either intravenous (IV) or SC treatment with IGSC, 10%. The IV or SC administration route was at the discretion of the participant and the investigator.

Key facts

Study ID

NCT01175213

Run by

Baxalta now part of Shire

People needed

66

Starts

2010-07-28

Expected to finish

2013-08-06

Last updated by the study team

2021-05-19

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has completed or is about to complete Baxter Clinical Study Protocol No. 160603. Participants 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.
• Participant/caretaker has reviewed, signed and dated informed consent
• Participant is willing and able to comply with the requirements of the protocol

You may not qualify if…

• Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in Study 160902
• Participant 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, participant is pregnant or has a negative pregnancy test and does not agree to employ adequate birth control measures for the duration of the study

Where it is running

• Study site — Cypress, California, United States
• Study site — Irvine, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Centennial, Colorado, United States
• Study site — North Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Hinsdale, Illinois, United States
• Study site — The Bronx, New York, United States
• Study site — Dallas, Texas, United States
• Study site — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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