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

Lymphatic Malformations Clinical Trial

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

Status Completed

Clinical Trial Summary

OBJECTIVES:

I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma.

Clinical Trial 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 ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Lymphatic Abnormalities
• Lymphatic Malformations

• NCT number: NCT00010452
• Study type: Interventional
• Source: FDA Office of Orphan Products Development
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 2000
• Completion date: November 2007