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
Recruiting now · Phase 2
Conditions studied: Lymphatic Malformation
In brief
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.
Key facts
- Study ID
- NCT05871970
- Run by
- Protara Therapeutics
- People needed
- 38
- Starts
- 2023-10-18
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-05-18
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 qualify 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.
Where it is running
- Children's Hospital of Alabama — Birmingham, Alabama, United States (enrolling)
- Arkansas Children's Hospital/UAMS — Little Rock, Arkansas, United States (enrolling)
- Children's Hospital of Colorado — Aurora, Colorado, United States (enrolling)
- Children's National Medical Center: Children's Research Institute — Washington D.C., District of Columbia, United States (enrolling)
- Nemours Children's Clinic - Jacksonville — Jacksonville, Florida, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- Children's Hospital of the King's Daughters — Norfolk, Virginia, United States (enrolling)
- Oregon Health & Science University — Portland, Oregon, United States (enrolling)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Children's Hospital of Philadelphia: Comprehensive Vascular Anomalies Program — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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