AngioedemaNCT00004694
Study of Heparin Prophylaxis of Hereditary Angioedema Exacerbations
A study testing heparin in people with Angioedema, run by University of Iowa.
Trial summary
OBJECTIVES: I. Determine the safety and efficacy of inhaled and subcutaneously administered heparin in the treatment of hereditary angioedema. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Angioedema
- What is being tested?
- heparin
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 1994to Sep 1998
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
About this study
OBJECTIVES:
- Determine the safety and efficacy of inhaled and subcutaneously administered heparin in the treatment of hereditary angioedema.
Read the 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
- Conditions
- Angioedema
- Being tested
- heparin
- Keywords
- genetic diseases and dysmorphic syndromes, hereditary angioedema, rare disease
- Medical subject headings
- Angioedema, Genetic Diseases, Inborn, Angioedemas, Hereditary, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startJan 1994
- Study completionSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngioedemaStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Investigators
- John M. Weiler, Study chair, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004694
- Sponsor's protocol ID
- 199/13356
- Other IDs
- UI-9311397, UI-FDR001001
- Status last verified
- Apr 1999
- First submitted
- 24 Feb 2000
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Heparin Prophylaxis of Hereditary Angioedema Exacerbations
- ClinicalTrials.gov ID
- NCT00004694
- Acronym / sponsor ID
- 199/13356
- Conditions
- Angioedema
- Keywords
- genetic diseases and dysmorphic syndromes, hereditary angioedema, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Jan 1994
- Study completion
- Sep 1998
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heparin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M. Weiler study chair
University of Iowa
Questions about this trial
What is this clinical trial studying?
A study testing heparin in people with Angioedema, run by University of Iowa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.