Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03427619 | OK432 (Picibanil) in the Treatment of Lymphatic Malformations | PHASE2 | COMPLETED | 275 | — | — | Oct 5, 2005 | Apr 30, 2018 | Nov 23, 2021 | 14 | United States |
Clinical success was defined as having either a complete (90% 100%) or substantial (60% 89%) reduction in lymphatic malformation (LM) volume after treatment. Response was determined using post treatment imaging studies at approximately 1 to 6 months after completion of treatment
| Arm | Type | Description |
|---|---|---|
| OK432 (Picibanil) | EXPERIMENTAL | There is no control in this study. All participants will receive the actual drug -OK432. With each injection they may receive 0.01 to 0.05mg/mL 6-12 weeks apart up to 4 injections total. |
| Name | Type | Description |
|---|---|---|
| OK432 | DRUG | OK432 will be injected at dosage of 0.01 to 0.05 mg/mL 6-12 weeks apart up to 4 injections total. |
Inclusion Criteria: To be eligible to receive OK432 immunotherapy * Patients must be ages 6 months to 17 years * Patients must have a macrocystic Lymphatic Malformation * Patients may have had surgical treatment for their Lymphatic Malformation * Patients must have an imaging study to confirm the ...