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Trial 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
NCT ID:
NCT05871970
Condition:
Lymphatic Malformation
Conditions: Official terms:
Lymphangioma
Lymphatic Abnormalities
Congenital Abnormalities
Conditions: Keywords:
Macrocystic lymphatic malformations
Mixed-cystic lymphatic malformations
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
TARA-002
Description:
All participants will receive up to 4 intracystic injections spaced approximately 6 weeks
apart.
Arm group label:
TARA-002
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.
Criteria for 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.
Gender:
All
Minimum age:
6 Months
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Children's Hospital of Alabama
Address:
City:
Birmingham
Zip:
35294
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Arkansas Children's Hospital/UAMS
Address:
City:
Little Rock
Zip:
72202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Children's Hospital of Colorado
Address:
City:
Aurora
Zip:
88045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Children's National Medical Center: Children's Research Institute
Address:
City:
Washington
Zip:
20010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Nemours Children's Clinic - Jacksonville
Address:
City:
Jacksonville
Zip:
32207
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Cincinnati Children's Hospital Medical Center
Address:
City:
Cincinnati
Zip:
45229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Children's Hospital of Philadelphia: Comprehensive Vascular Anomalies Program
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Vanderbilt University Medical Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Children's Hospital of the King's Daughters
Address:
City:
Norfolk
Zip:
23507
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Start date:
October 18, 2023
Completion date:
May 2026
Lead sponsor:
Agency:
Protara Therapeutics
Agency class:
Industry
Source:
Protara Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05871970
