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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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% 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.

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 the product is licensed (trade name GAMMAGARD LIQUID) for the intravenous (IV) and SC replacement therapy of antibody deficiency in patients with PID. In the EU this product is licensed (trade name KIOVIG) IGSC, 10% with rHuPH20 established name is Innume Glubulin Infusion 10% (Human) with Recombinant Human Hyualuronidase. US trade name is HYQVIA EU trade name is HyQvia

Conditions

• Primary Immunodeficiency Diseases (PID)

Interventions

Type	Name	Description
BIOLOGICAL	SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety)	Participants are to continue on the same doses and treatment intervals of IGSC, 10% adjusted for body weight, and rHuPH20 that were used for the last infusions in Study epoch 2 of Study 160603 (NCT00814320). After 3 infusions, participants are to change treatment to a 2-week interval, if agreed with participant and investigator. During this safety follow-up period, participants are treated with IGSC, 10% via the SC route. Treatment occurred once every week. The dose was the weekly equivalent of the most recent IV dose (adjusted per body weight) and multiplied by 1.37.
BIOLOGICAL	SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety)	Participants are to continue on the same doses and treatment intervals of IGSC, 10% adjusted for body weight, and rHuPH20 that were used for the last infusions in Study epoch 2 of Study 160603 (NCT00814320). After 3 infusions, participants are to change treatment to a 2-week interval, if agreed with participant and investigator. During this safety follow-up period, participants are treated with IGSC, 10% via the intravenous (IV) route. Treatment occurred once every 3-4 weeks. The weekly dose equivalent was 100% of the most recent IV dose.
BIOLOGICAL	IV treatment with IGSC, 10%	During this safety follow-up period, participants are treated with IGSC, 10% via the intravenous (IV) route.

Timeline

• Start date: 2010-07-28
• Primary completion: 2013-08-06
• Completion: 2013-08-06
• First posted: 2010-08-04
• Last updated: 2021-05-19
• Results posted: 2016-05-26

Locations

11 sites across 1 country: United States