Description
This study is for people with growing abnormal lymph vessels called lymphatic malformations (LMs). This study has 3 parts and involves taking a study drug called TARA-002. The purpose of this study is to find out if the study drug is safe and effective (can help) people with LMs. Participants receive the study drug by injection and will complete other research assessments throughout the study.
What to expect
This study will enroll patients who are at least 6 months of age and less than 18 years of age. Study participation lasts up to 54 weeks and requires 8 research clinic visits. This study has 3 parts: a Screening Period (about 4 weeks), a Treatment Period (about 18 weeks), and a Follow-up Period (about 32 weeks). Participants take the study drug injection up to 4 times about 6 weeks apart during the study visits. In addition to receiving study drug, visits include the following assessments: blood draws, electrocardiograms (ECGs), CT scans (x-rays), ultrasounds, photographs of lesions, completion of questionnaires, interviews, and diaries. Some study imaging procedures may require use of contrast and/or sedation (anesthesia). Some participants may have a penicillin allergy test and COVID-19 test.Reimbursement for travel may be provided.
