Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shire
A total of 113 subjects were enrolled in the study. One-hundred-one (101) subjects received C1INH-nf for the treatment of 1 or more HAE attacks and were analyzed for efficacy. The study design also allowed for short-term prophylaxis with C1INH-nf prior to emergency or non-cosmetic surgical or dental procedures, and an additional 12 subjects received C1INH-nf only for this purpose. All 113 subjects were exposed to C1INH-nf and analyzed for safety.
Age
1–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
This study was open to all subjects who:
Completed participation in LEVP2005-1/A (NCT00289211) and were not participating in LEVP2005-1/B (NCT01005888), any time after the 3-day telephone follow-up
Completed participation in LEVP2005-1/B any time after the final prophylactic therapy in Part B
Were enrolled but not randomized in LEVP2005-1/A after Part A was closed
Were excluded from LEVP2005-1 for any of the following reasons:
* Pregnancy or lactation
* Age less than 6 years
* Narcotic addiction
* Presence of anti-C1INH autoantibodies
Were not enrolled in LEVP2005-1 after enrollment in LEVP2005-1 was closed, under the following circumstances:
* Had a diagnosis of HAE: evidence of a low C4 level plus either a low C1INH antigenic level or a low C1INH functional level, or
* Had a known HAE-causing C1INH mutation, or
* Had a diagnosis of HAE based on a strong family history of HAE as determined by the principal investigator
You may not be if
History of allergic reaction to C1INH or other blood products
Participated in any other investigational drug study within the past 30 days
Received blood or a blood product in the past 60 days other than C1INH-nf
Clareo Health | Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
