Study of Heparin Prophylaxis of Hereditary Angioedema Exacerbations

NCT00004694 | Completed

• 3 other identifiers: 199/13356UI-9311397UI-FDR001001
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Angioedema

Keywords

genetic diseases and dysmorphic syndromes; hereditary angioedema; rare disease

Interventions

heparin DRUG

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Iowa: lead

MeSH Terms

Conditions

Angioedema; Genetic Diseases, Inborn; Angioedemas, Hereditary; Rare Diseases

Interventions

Heparin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• John M. Weiler

  University of Iowa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: January 1, 1994
• Study Completion: September 1, 1998
• Last Updated: March 25, 2015

Record last verified: 1999-04