Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010452
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2001-02-02
Brief Title:
Study of Picibanil OK432 Sclerotherapy in Children With Macrocystic Lymphatic Malformations
Sponsor:
University of Iowa
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Treatment of Cystic Hygroma Lymphangiomas in Children- PicibanilOK432 Sclerotherapy-Multicenter Trial
Status:
COMPLETED
Status Verified Date:
2008-01
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 efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma
I Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma
Detailed Description:
PROTOCOL OUTLINE This is a multicenter study Patients are stratified according to prior treatment no prior treatment vs prior surgical treatment and geographic area
Patients who meet all study criteria are put in the Immediate Treatment Group Patients receive an intralesional injection of picibanil OK432 with the aid of ultrasonography or transillumination for localization of cysts Treatment repeats every 6-8 weeks for a total of up to 4 injections
After completion of treatment patients are followed at 6 months 1 year and 2 years
Completion date provided represents the completion date of the grant per OOPD records
Patients who meet all study criteria are put in the Immediate Treatment Group Patients receive an intralesional injection of picibanil OK432 with the aid of ultrasonography or transillumination for localization of cysts Treatment repeats every 6-8 weeks for a total of up to 4 injections
After completion of treatment patients are followed at 6 months 1 year and 2 years
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UIHC-FDR001774 | None | None | None |