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drugset / Trial / NCT00782106

Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously

NCT00782106 ↗

Phase 1/2 Completed 11 enrolled Baxalta now part of Shire
Parallel-groupOpen-labelTreatment

Summary

The purpose of the study is to determine the feasibility of infusing a full 4-week dose of Immune Globulin Intravenous (Human), 10% in a single subcutaneous site and the amount of recombinant human hyaluronidase needed to infuse that dose with no more than mild local adverse drug reactions.

Timeline

Start
2006-12-04
Primary completion
2007-11-01
Completion
2007-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 600 mg/kg Subcutaneous
Subject rHuPH20 Protein / enzyme biologic — Subcutaneous

Indications

immunodeficiency disease