Study of Heparin Prophylaxis of Hereditary Angioedema Exacerbations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Iowa
- Enrollment
- 24
Study Overview
Brief Summary
OBJECTIVES:
I. Determine the safety and efficacy of inhaled and subcutaneously administered heparin in the treatment of hereditary angioedema.
Detailed Description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, 3 way crossover study.
All patients complete diary cards for the first month of the study in order to determine compliance in providing a daily record of symptoms and medication taken. All compliant patients receive subcutaneously injected heparin twice daily, inhaled heparin daily, or matched saline placebo in a random order. Each of the three drug administration periods lasts 2 months, for a total of 6 months of treatment. Patients who have a flare in disease activity that requires hospitalization are terminated from that drug administration period of the study.
Patients are followed biweekly during the first month and again at the end of the second month for each of the three 2 month drug administration periods.
Completion date provided represents the completion date of the grant per OOPD records
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 8 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided