Completed PHASE3 INTERVENTIONAL 3-arm NCT01175213

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

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

Sponsor: Baxalta now part of Shire

Conditions Primary Immunodeficiency Diseases (PID)

Interventions IV treatment with IGSC, 10% SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety) SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety)

Updated 10 times since 2017 Last updated: Apr 30, 2021 Started: Jul 28, 2010 Primary completion: Aug 6, 2013 Completion: Aug 6, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01175213, this PHASE3 trial focuses on Primary Immunodeficiency Diseases (PID) and remains completed. Sponsored by Baxalta now part of Shire, it has been updated 10 times since 2010, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

10 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jun 2021 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Jun 2021 [monthly]

Completed PHASE3

▶ Show 5 earlier versions

Jan 2019 — Jan 2021 [monthly]

Completed PHASE3
Jun 2018 — Jan 2019 [monthly]

Completed PHASE3
Nov 2017 — Jun 2018 [monthly]

Completed PHASE3
Feb 2017 — Nov 2017 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Jul 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Baxalta now part of Shire

Data source: Takeda

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Centennial, United States , Cypress, United States , Dallas, United States , Galveston, United States , Hinsdale, United States , Irvine, United States , Los Angeles, United States , North Palm Beach, United States , San Francisco, United States and 1 more location