NCT01485796

Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD

Tolerability, Safety and Administration Mode Evaluation of Recombinant Human Hyaluronidase (rHuPH20) Facilitated Subcutaneous Treatment With Immune Globulin Infusion (Human), 10% in Subjects With Primary Immunodeficiency Diseases (PIDD)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to acquire additional data on safety and tolerability of recombinant human hyaluronidase (rHuPH20) facilitated subcutaneous treatment of Immune Globulin Infusion (Human), 10% (IGI, 10%) and to assess the mode of product administration. Following a discussion with the FDA at the end of July 2012, 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 treatment with the licensed product IGI, 10% (Gammagard Liquid). The intravenous or subcutaneous administration route was at the discretion of the participant and the investigator.

Conditions

• Primary Immunodeficiency Diseases (PID)

Interventions

Type	Name	Description
BIOLOGICAL	Immune Globulin Infusion (Human), 10%	Subcutaneous administration will be used in Study Epochs 1 and 2.
BIOLOGICAL	Recombinant human hyaluronidase	rHuPH20 will be administered subcutaneously (SC) immediately before each SC IGI, 10% infusion, through the same needle, at a rate of 1 to 2 mL/min.

Timeline

• Start date: 2011-12-29
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-12-06
• Last updated: 2021-05-19
• Results posted: 2017-04-24

Locations

10 sites across 1 country: United States