NCT05871970 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
| NCT ID | NCT05871970 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Protara Therapeutics |
| Condition | Lymphatic Malformation |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2023-10-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 38 participants in total. It began in 2023-10-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Chief Scientific Operations Officer
STUDY DIRECTOR
Protara Therapeutics
Frequently Asked Questions
Who can join the NCT05871970 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 18 Years, studying Lymphatic Malformation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05871970 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05871970 currently recruiting?
Yes, NCT05871970 is actively recruiting participants. Contact the research team at clinicaltrials@protaratx.com for enrollment information.
Where is the NCT05871970 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Aurora, United States, Washington D.C., United States and 6 additional locations.
Who is sponsoring the NCT05871970 clinical trial?
NCT05871970 is sponsored by Protara Therapeutics. The principal investigator is Chief Scientific Operations Officer at Protara Therapeutics. The trial plans to enroll 38 participants.