Study of Heparin Prophylaxis of Hereditary Angioedema Exacerbations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004694|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
I. Determine the safety and efficacy of inhaled and subcutaneously administered heparin in the treatment of hereditary angioedema.
|Condition or disease||Intervention/treatment|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Study Start Date :||January 1994|
|Estimated Study Completion Date :||September 1998|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004694
|Study Chair:||John M. Weiler||University of Iowa|