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Virus Therapy
TARA-002 Injection for Lymphatic Malformations (STARBORN-1 Trial)
Phase 2
Recruiting
Research Sponsored by Protara Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial evaluates the safety & efficacy of an injection to treat cystic lymphatic malformations in kids 6 months to 18 years old. Safety must be established in older kids before treating younger ones.
Who is the study for?
This trial is for kids and teens from 6 months to under 18 years with large or mixed fluid-filled lumps in the head, neck, or chest area. They can join if they've had treatments before but not within the last six months. Kids allergic to penicillin, with blood vessel tumors, mostly small cysts, or eye socket involvement can't participate.
What is being tested?
The study tests TARA-002 injections directly into these lumps. It's a two-part study: first ensuring it's safe for older kids (6-17 years) then younger ones (6 months-5 years). If safe, more kids will get up to four shots about six weeks apart in the second part of the study.
What are the potential side effects?
Possible side effects aren't detailed here but may include reactions at the injection site and other responses typical of biological therapies. The trial aims to establish safety so close monitoring for any adverse effects is expected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TARA-002Experimental Treatment1 Intervention
TARA-002 is a lyophilized biological preparation for injection containing cells of Streptococcus pyogenes (Group A, type 3) Su strain treated with benzylpenicillin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TARA-002
2023
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
Protara TherapeuticsLead Sponsor
4 Previous Clinical Trials
229 Total Patients Enrolled
Chief Scientific Operations OfficerStudy DirectorProtara Therapeutics
4 Previous Clinical Trials
229 Total Patients Enrolled