Status:
COMPLETED
Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Primary Immunodeficiency Diseases (PID)
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
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% facilita...
Detailed Description
IGSC, 10% is the same product as IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% (IGIV, 10%) quoted in study 160603. IGSC, 10% is abbreviated to IGI, 10% \[IMMUNE GLOBULIN INFUSION (HUMAN), 10%\] In the US...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 28 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2013
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01175213
Start Date
July 28 2010
End Date
August 6 2013
Last Update
May 19 2021
Active Locations (11)
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1
Cypress, California, United States
2
Irvine, California, United States
3
Los Angeles, California, United States
4
San Francisco, California, United States