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OK432 (Picibanil) in the Treatment of Lymphatic Malformations

NCT03427619 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2021-11-23

Study results available
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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.

Conditions

  • Lymphatic Malformations

Interventions

DRUG

OK432

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

Sponsors & Collaborators

  • Richard JH Smith

    lead OTHER

Principal Investigators

  • Richard JH Smith, MD · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-05
Primary Completion
2018-04-30
Completion
2018-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03427619 on ClinicalTrials.gov