Study of Heparin Prophylaxis of Hereditary Angioedema Exacerbations

• Status: Completed
• Trial end date: 1998-09-01
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES:

I. Determine the safety and efficacy of inhaled and subcutaneously administered heparin in the treatment of hereditary angioedema.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Iowa
• Treatments: Calcium heparin; Heparin

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Confirmed diagnosis of hereditary angioedema (HAE) based upon C4 antigenic level, positive family history, and C1 inhibitor (C1INH) antigenic level (Type I HAE) or functional level (Type II HAE)

• Functional C1 within normal levels if diagnosis of acquired C1INH is possible

• Negative family history will not exclude as long as patient meets all other criteria, has normal C1 level, and has no evidence of acquired C1INH deficiency

• History of symptoms of HAE including episodic swelling, abdominal pain, and/or respiratory difficulty

• Experiencing a minimum of 1-2 HAE episodes within 6 weeks

--Prior/Concurrent Therapy--

• Endocrine therapy: Anabolic steroids allowed as long as dose has not been changed in at least 30 days

• Other: No concurrent and at least 1 week since prior aspirin, nonsteroidal antiinflammatory agents, dipyridamole, Coumadin-like drugs, or any other medication having an effect on coagulation or platelets

--Patient Characteristics--

• Hematopoietic: No clinically significant history of hematologic disease

• Hepatic: No clinically significant history of hepatic disease

• Renal: No clinically significant history of renal disease

• Cardiovascular: No clinically significant history of cardiac disease or hypertension

• Pulmonary: No clinically significant history of pulmonary disease

• Other: No contraindication to the use of inhaled or subcutaneous heparin No drug allergy that would interfere with the study No clinically significant history of: Malignancy Diabetes mellitus Neurologic disease Immunologic disease Bleeding disorder Infirmity No history of drug abuse, alcoholism, psychosis, or other psychological/psychiatric disorder