Study of Heparin Prophylaxis of Hereditary Angioedema Exacerbations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 1999 by FDA Office of Orphan Products Development.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Iowa
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004694
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: April 1999
  Purpose

OBJECTIVES:

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


Condition Intervention
Angioedema
Drug: heparin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 24
Study Start Date: January 1994
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.

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004694

Sponsors and Collaborators
University of Iowa
Investigators
Study Chair: John M. Weiler University of Iowa
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004694     History of Changes
Other Study ID Numbers: 199/13356, UI-9311397, UI-FDR001001
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
genetic diseases and dysmorphic syndromes
hereditary angioedema
rare disease

Additional relevant MeSH terms:
Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014