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Study of Heparin Prophylaxis of Hereditary Angioedema Exacerbations

Primary Purpose

Angioedema

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
heparin
Sponsored by
University of Iowa
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angioedema focused on measuring genetic diseases and dysmorphic syndromes, hereditary angioedema, rare disease

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    March 24, 2015
    Sponsor
    University of Iowa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004694
    Brief Title
    Study of Heparin Prophylaxis of Hereditary Angioedema Exacerbations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 1999
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1994 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 1998 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Iowa

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Angioedema
    Keywords
    genetic diseases and dysmorphic syndromes, hereditary angioedema, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    24 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    heparin

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John M. Weiler
    Organizational Affiliation
    University of Iowa
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Study of Heparin Prophylaxis of Hereditary Angioedema Exacerbations

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