NCT01426763

A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase

An Open-label Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Hereditary Angioedema

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

Summary

The objectives of the study are to: 1. Evaluate the safety and tolerability of subcutaneously administered CINRYZE with recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedema (HAE) who previously participated in CINRYZE Study 0624-200 (NCT01095497) 2. Characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered CINRYZE with rHuPH20 3. Assess the immunogenicity of CINRYZE following subcutaneous (SC) administration of CINRYZE with rHuPH20

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
BIOLOGICAL	CINRYZE with rHuPH20

Timeline

• Start date: 2011-09-12
• Primary completion: 2011-11-28
• Completion: 2011-11-28
• First posted: 2011-08-31
• Last updated: 2021-07-19
• Results posted: 2013-01-04

Locations

4 sites across 1 country: United States