Study of Heparin Prophylaxis of Hereditary Angioedema Exacerbations

March 24, 2015 updated by: University of Iowa

OBJECTIVES:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1994

Study Completion

September 1, 1998

Study Registration Dates

First Submitted

February 24, 2000

First Submitted That Met QC Criteria

February 24, 2000

First Posted (Estimate)

February 25, 2000

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

April 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/13356
  • UI-9311397
  • UI-FDR001001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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