drugset / Trial / NCT01756157

Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks

NCT01756157

Phase 2 Completed 47 enrolled Shire
RandomizedCrossoverQuadruple-blindPrevention

Summary

The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by subcutaneous (SC) injection to prevent angioedema attacks.

Timeline

Start
2013-02-04
Primary completion
2013-09-13
Completion
2013-09-13

Drugs

EvaluationDrugModalityDoseRoute
Subject CINRYZE Protein / enzyme biologic 1000 iu Subcutaneous
Subject CINRYZE Protein / enzyme biologic 2000 iu Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 24000 iu Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 48000 iu Subcutaneous

Indications