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Study of Heparin Prophylaxis of Hereditary Angioedema Exacerbations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004694
First Posted: February 25, 2000
Last Update Posted: March 25, 2015
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.
Information provided by:
FDA Office of Orphan Products Development
  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
Intervention Model: Crossover Assignment
Masking: Single
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
Estimated Study Completion Date: September 1998
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

ClinicalTrials.gov Identifier: NCT00004694     History of Changes
Other Study ID Numbers: 199/13356
UI-9311397
UI-FDR001001
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: March 25, 2015
Last Verified: April 1999

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
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action