NCT01756157

Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks

A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Ranging, Crossover Study to Evaluate the Safety and Efficacy of Subcutaneous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase (rHuPH20) for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hereditary Angioedema (HAE)

Interventions

Type	Name	Description
BIOLOGICAL	CINRYZE with rHuPH20

Timeline

• Start date: 2013-02-04
• Primary completion: 2013-09-13
• Completion: 2013-09-13
• First posted: 2012-12-25
• Last updated: 2021-06-03
• Results posted: 2015-06-12

Locations

23 sites across 4 countries: United States, Germany, Spain, Sweden