Actively Recruiting
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
Led by Protara Therapeutics · Updated on 2025-10-23
38
Participants Needed
10
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants 6 months to less than 18 years of age at the time of informed consent/assent
- Parent or legal representative has given written consent and participant provided assent if applicable
- Diagnosis of macrocystic or mixed cystic lymphatic malformations with at least 50% macrocystic disease in the head, neck, or mediastinum confirmed by imaging
- Participants may have had surgery or sclerotherapy for lymphatic malformations, but not within 6 months before consent/assent
You will not qualify if you...
- Allergy to penicillin
- Presence of vascular tumors or combined vascular malformations
- Microcystic lymphatic malformations or mixed cystic lymphatic malformations with mainly microcystic features
- Lymphatic malformations located in the orbit (orbital lymphatic malformations) as the target cyst
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Arkansas Children's Hospital/UAMS
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
Children's Hospital of Colorado
Aurora, Colorado, United States, 88045
Actively Recruiting
4
Children's National Medical Center: Children's Research Institute
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
5
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
6
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
7
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
8
Children's Hospital of Philadelphia: Comprehensive Vascular Anomalies Program
Philadelphia, Pennsylvania, United States, 19104
Withdrawn
9
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
10
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 23507
Actively Recruiting
Research Team
C
Chief Scientific Operations Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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