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
13
sites
Click here to add this to my saved trials
University of Cincinnati Medical Center Opening in 1823 as the country
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
Click here to add this to my saved trials
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials