Male or female participants 6 months to less than 18 years of age at the time of informed consent/assent form was signed
Participants whose parent/LAR(s) have voluntarily given written consent and participants who provided assent (if applicable) after the study has been explained to them
Participants with macrocystic LM or mixed cystic LM (≥ 50% macrocystic disease measured by volume) of the Head/Neck/Mediastinum according to the ISSVA 2018 criteria (ISSVA 2018) measured via LM imaging at Screening to confirm, upon central review, the diagnosis of macrocystic or mixed cystic LM
Participants who may have had surgical or sclerotherapy treatment for their LM, but not within six months of the consent/assent form being signed
You may not be if
Penicillin allergy
Vascular tumors or combined vascular malformations
Microcystic LM or mixed cystic LM with predominant microcystic features
LMs of the orbit (orbital LM) as target cyst
For more information on eligibility criteria, please contact the sponsor.
Clareo Health | Safety and Efficacy Study of Intracystic TARA-002 for the Treatment of Lymphatic Malformations in Participants 6 Months to Less Than 18 Years of Age
