NCT00814320

Gammagard Liquid and rHuPH20 in PID

Efficacy, Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG) Administered Intravenously or Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency Diseases

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 89 (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 develop a subcutaneous treatment option for participants with Primary Immunodeficiency Diseases (PID) that allows an administration of Immune Globulin Intravenous (Human), 10% at the same frequency as IV administration.

Conditions

• Primary Immunodeficiency Diseases (PID)

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)	Comprises subjects previously participating in Study 160601, who now only complete Study Epoch 2 (subcutaneous \[SC\] infusions) as bioavailability/exposure for intravenous (IV) treatment was already obtained in Study 160601. Study Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment (ramp-up).
BIOLOGICAL	Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)	Comprises all other subjects. Study Epoch 1: IV infusion of IGIV, 10% (same dose and frequency as pre-study) to determine pharmacokinetics. Study Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment (ramp-up).

Timeline

• Start date: 2008-12-18
• Primary completion: 2010-11-11
• Completion: 2010-11-11
• First posted: 2008-12-24
• Last updated: 2021-05-19
• Results posted: 2015-12-03

Locations

14 sites across 2 countries: United States, Canada