drugset / Trial / NCT03427619

OK432 (Picibanil) in the Treatment of Lymphatic Malformations

NCT03427619

Phase 2 Completed 275 enrolled Richard JH Smith
NaSingle-groupOpen-labelTreatment

Summary

Standard of care for Lymphatic Malformations has been surgical excision. We have been using OK432/Picibanil (generously supplied by Chugai Pharmaceuticals in Japan) since 1992 with great success for macrocystic disease. The objective of the study was to provide OK-432 immunotherapy to subjects with macrocystic or mixed (\> 50% macrocystic) lymphatic malformations (LMs) and investigate the efficacy and safety of OK 432 as a treatment option in subjects with LMs.

Timeline

Start
2005-10-05
Primary completion
2018-04-30
Completion
2018-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject OK-432 Unknown 0.01 mg/ml
Subject OK-432 Unknown 0.05 mg/ml