NCT00010452

Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations

Treatment of Cystic Hygroma (Lymphangiomas) in Children- Picibanil(OK432) Sclerotherapy-Multicenter Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: 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

Conditions

• Lymphatic Malformations

Interventions

Type	Name	Description
DRUG	picibanil	Up to .2 mg per injection, given intralesionally every 6-8 weeks

Timeline

• Start date: 2000-04-01
• Primary completion: 2006-06-01
• Completion: 2007-11-01
• First posted: 2001-02-02
• Last updated: 2015-03-25

Locations

13 sites across 1 country: United States