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
Protara Therapeutics · NCT05871970
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 6 mo–18 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 38
- US sites recruiting
- 9
- Study start
- October 18, 2023
- Record last updated
- August 24, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: TARA-002
Conditions: Lymphatic Malformation
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Children's Hospital of Alabama
Birmingham, AL 35294
Site contact: TAYLOR BRINKLEY · tebrinkley@uabmc.edu
Arkansas Children's Hospital/UAMS
Little Rock, AR 72202
Site contact: LEKIVIA COBB · cobblc@archildrens.org
Children's Hospital of Colorado
Aurora, CO 88045
Site contact: MATTHEW MCCLUNG · matthew.mcclung@childrenscolorado.org
Children's National Medical Center: Children's Research Institute
Washington D.C., DC 20010
Site contact: HENGAMEH BEHZADPOUR · hbehzadpou@childrensnational.org
Nemours Children's Clinic - Jacksonville
Jacksonville, FL 32207
Site contact: ROSITA ALMIRA · rosita.almira@nemours.org
Mount Sinai Hospital
New York, NY 10029
Site contact: ARMAND HARB · armand.harb@mountsinai.org
Oregon Health & Science University
Portland, OR 97239
Site contact: LORI RUSSELL · watsonlo@ohsu.edu
Vanderbilt University Medical Center
Nashville, TN 37232
Site contact: KALPNABEN PATEL · kalpnaben.patel@vumc.org
Children's Hospital of the King's Daughters
Norfolk, VA 23507
Site contact: LAURA STONE · stonelj@odu.edu
Study contacts (from the official record)
- Chief R&D Officer · 16468440337 · clinicaltrials@protaratx.com