CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 275 enrolled
Drug / intervention
OK432drug
Likely dose
OK432 0.05 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03427619
NCT03427619Phase 2Completed
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A Phase 2, Multicenter, Open Label Study to Evaluate the Efficacy and Safety of OK-432 Immunotherapy in Individuals With Lymphatic Malformations

Richard JH Smith·interventional·Posted Feb 9, 2018·Updated Nov 23, 2021

In Brief

A Phase 2 clinical trial evaluating OK432 for Lymphatic Malformations. Completed, enrolled 275 participants across 14 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphatic Malformations
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 9, 2018
Enrollment StartOct 5, 2005
Primary CompletionApr 30, 2018
TodayJul 2, 2026
Enrollment to primary: 12.6 yearsPosted 8.4 years ago

Interventions

OK432drug

OK432 will be injected at dosage of 0.01 to 0.05 mg/mL 6-12 weeks apart up to 4 injections total.