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Study of Heparin Prophylaxis of Hereditary Angioedema Exacerbations

Sponsor
University of Iowa (Other)
Overall Status
Completed
CT.gov ID
NCT00004694
Collaborator
(none)
24
Enrollment
56
Duration (Months)

Study Details

Study Description

Brief Summary

OBJECTIVES:
  1. Determine the safety and efficacy of inhaled and subcutaneously administered heparin in the treatment of hereditary angioedema.
Condition or Disease Intervention/Treatment Phase
N/A

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

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 1994
Study Completion Date :
Sep 1, 1998

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Iowa

    Investigators

    • Study Chair: John M. Weiler, University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004694
    Other Study ID Numbers:
    • 199/13356
    • UI-9311397
    • UI-FDR001001
    First Posted:
    Feb 25, 2000
    Last Update Posted:
    Mar 25, 2015
    Last Verified:
    Apr 1, 1999
    Keywords provided by , ,
    genetic diseases and dysmorphic syndromes
    hereditary angioedema
    rare disease
    Additional relevant MeSH terms:
    Angioedema
    Heparin

    Study Results

    No Results Posted as of Mar 25, 2015