Condition: Lymphatic Malformation · Sponsor: Protara Therapeutics
This is a Phase 2a/b single arm open label study to evaluate the safety, reactogenicity, and efficacy of intracystic injection of TARA-002 in participants 6 months to less than 18 years of age for the treatment of macrocystic and mixed cystic lymphatic malformations. The Phase 2a safety lead-in, age de-escalation study is designed to establish the safety of TARA-002 in older participants 6 years to less than 18 years before proceeding to younger participants 2 years to less than 6 years, then 6 months to less than 2 years. The Phase 2b is an expansion study in which enrollment of participants will be initiated after safety has been established in each cohort during the Phase 2a safety lead-in study. Each participant will receive up to 4 injections of TARA-002 spaced approximately 6 weeks apart.
This description comes directly from the study's public registry record.
Chief Scientific Operations Officer · 16468440337 · clinicaltrials@protaratx.com
Always discuss trial participation with your own doctor first.
| Children's Hospital of Alabama | Birmingham, Alabama, United States | Recruiting |
| Arkansas Children's Hospital/UAMS | Little Rock, Arkansas, United States | Recruiting |
| Children's Hospital of Colorado | Aurora, Colorado, United States | Recruiting |
| Children's National Medical Center: Children's Research Institute | Washington D.C., District of Columbia, United States | Recruiting |
| Nemours Children's Clinic - Jacksonville | Jacksonville, Florida, United States | Recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, United States | Withdrawn |
| Oregon Health & Science University | Portland, Oregon, United States | Recruiting |
| Children's Hospital of Philadelphia: Comprehensive Vascular Anomalies Program | Philadelphia, Pennsylvania, United States | Withdrawn |
| Vanderbilt University Medical Center | Nashville, Tennessee, United States | Recruiting |
| Children's Hospital of the King's Daughters | Norfolk, Virginia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05871970