Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004694
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Study of Heparin Prophylaxis of Hereditary Angioedema Exacerbations
Sponsor:
University of Iowa
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
I Determine the safety and efficacy of inhaled and subcutaneously administered heparin in the treatment of hereditary angioedema
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UI-FDR001001 | None | None | None |
| UI-9311397 | None | None | None |