Status:
WITHDRAWN
C1-INH Compared to Placebo at the Time of Prodromal Symptoms for Hereditary Angioedema (HAE) Exacerbation
Lead Sponsor:
Penn State University
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The study hypothesis is that treatment of Hereditary Angioedema at the time of prodromal symptoms will decrease morbidity associated with the disease
Detailed Description
Section 3 Study Design and Methods: Our proposal is to perform a randomized double-blind, three-arm, three-way cross-over study in which subjects with HAE would be placed into one of three different ...
Eligibility Criteria
Inclusion
- Documented HAE type 1 or 2 by C4 level and C1-INH level or function.
- Able to read, understand, and sign informed consent.
- Above the age of 12 years.
- Willing to complete daily diary.
- Have at least 1 HAE exacerbations per month averaged over the last 6 months.
- Prodromal symptoms will not be an inclusion or exclusion since if used it would bias our ability to determine specificity and sensitivity of prodromal symptoms.
- Present for treatment within 6 hours of onset of prodromal symptoms.
- Treatment for an acute attack can be given at any time without restriction.
Exclusion
- Inability to read English.
- Prior adverse effects to C1-INH.
- Participation in alternate investigational drug trial.
- Diabetes, neurologic diseases, cardiac diseases, dermatologic diseases that may have associated symptoms that mimic prodromal symptoms.
- Inability to withdraw from androgens or C1-INH prophylaxis.
- Pregnant or breast feeding mothers.
- Prisoners or other institutionalized individuals.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01151735
Start Date
July 1 2010
End Date
July 1 2012
Last Update
November 30 2012
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