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New injection could help kids with rare growths avoid major surgery

NCT ID NCT05871970

Disease control Sponsor: Protara Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This study tests an injected medicine called TARA-002 for children aged 6 months to 18 years who have lymphatic malformations (fluid-filled cysts). The goal is to see if the injections can safely shrink or eliminate the cysts. Up to 38 children will receive up to 4 injections, each about 6 weeks apart. The study is currently recruiting.

Why investors are watching

Protara Therapeutics is testing TARA-002, an injected treatment for children with lymphatic malformations, a condition where fluid-filled cysts form in the body. This is a small company, so the outcome of this 38-patient trial could significantly affect its future. The trial's phased design, starting with older children and moving to younger ones, means early safety data will be a key focus.

If it works: If the trial shows TARA-002 is safe and shrinks the cysts, Protara could have a new treatment for a condition with few options. A positive result might attract partners or funding to continue development.

If it fails: The trial could fail to show enough benefit or reveal safety problems, which would be a major setback for a company of this size. Many trials fail, and delays in enrollment or safety reviews could also hurt the company's prospects.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 38 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Lymphatic Abnormalities lymphatic malformation macrocystic lymphatic malformation mixed cystic lymphatic malformation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphatic malformation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Arkansas Children's Hospital/UAMS

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Children's Hospital of Alabama

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • Children's Hospital of Colorado

    RECRUITING

    Aurora, Colorado, 88045, United States

  • Children's Hospital of Philadelphia: Comprehensive Vascular Anomalies Program

    WITHDRAWN

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of the King's Daughters

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Children's National Medical Center: Children's Research Institute

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    WITHDRAWN

    Cincinnati, Ohio, 45229, United States

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • Nemours Children's Clinic - Jacksonville

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.