A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE (C1 Inhibitor [Human])

Status:	Archived
Conditions:	Skin and Soft Tissue Infections
Therapuetic Areas:	Dermatology / Plastic Surgery
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	July 2009

A Phase 4 Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE (C1 Inhibitor [Human]) as Prophylactic Therapy in Subjects With Inadequately Controlled Hereditary Angioedema Attacks.

The objectives of the study are:

1. To assess the safety and tolerability of escalating doses of CINRYZE.

2. To assess the effect of an escalating dose algorithm for CINRYZE on HAE attack rates.

3. To assess the immunogenicity of CINRYZE.

This open-label, multicenter, Phase 4 study will assess escalating doses of CINRYZE as
prophylactic therapy to lower the HAE attack rate in subjects who are not adequately
controlled at the recommended CINRYZE dosing regimen.

There will be three potential dose escalation steps for 12 week periods each:

Step 1: 1500 Units twice per week Step 2: 2000 Units twice per week Step 3: 2500 Units
twice per week

We found this trial at

sites

University of Cincinnati Medical Center

234 Goodman Dr
Cincinnati, Ohio 45229

(513) 584-1000