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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
NCT05871970 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL TARA-002
Study Locations (10)
Alabama
- Children's Hospital of Alabama — Birmingham
Arkansas
- Arkansas Children's Hospital/UAMS — Little Rock
Colorado
- Children's Hospital of Colorado — Aurora
District of Columbia
- Children's National Medical Center: Children's Research Institute — Washington D.C.
Florida
- Nemours Children's Clinic - Jacksonville — Jacksonville
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
Oregon
- Oregon Health & Science University — Portland
Pennsylvania
- Children's Hospital of Philadelphia: Comprehensive Vascular Anomalies Program — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2023-10-18 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05871970
The ClinicalTrials.gov registry entry for NCT05871970 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Protara Therapeutics, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Lymphatic Malformation appearing as the primary indexed condition, and to 1 intervention — of which TARA-002 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05871970 reports 10 study locations spanning 10 distinct geographic areas — top geographies include Alabama, Arkansas, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05871970 about?
NCT05871970 is a clinical study titled "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". 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...
What is the current status of trial NCT05871970?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2023-10-18. Estimated completion is 2026-05.
What conditions does trial NCT05871970 study?
This clinical trial studies the following conditions: Lymphatic Malformation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05871970?
The interventions under investigation include: TARA-002 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05871970?
This trial is sponsored by Protara Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05871970 being conducted?
This trial has 10 study locations across Alabama, Arkansas, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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