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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 8 weeks after last injection and 32 weeks after last injection

Awards & highlights

STARBORN-1 Trial 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.Check my eligibility

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.See study design

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.

STARBORN-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks after last injection and 32 weeks after last injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks after last injection and 32 weeks after last injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks after last injection and 32 weeks after last injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of participants with clinical success after one treatment cycle of TARA-002

Secondary outcome measures

Clinical Success by LM Type: Proportion of participants with macrocystic LM or mixed cystic LM with clinical success after one treatment cycle of TARA-002

Durable Response: Proportion of participants with clinical success after one treatment cycle of TARA-002 assessed at 8 weeks after the last injection and maintained clinical success at 32 weeks after the last injection

Investigator Assessment: Proportion of participants who demonstrate clinical improvement, as assessed by the Investigator, after one treatment cycle of TARA-002 compared to baseline

+4 more

STARBORN-1 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Protara TherapeuticsLead Sponsor

4 Previous Clinical Trials

212 Total Patients Enrolled

Chief Scientific Operations OfficerStudy DirectorProtara Therapeutics

4 Previous Clinical Trials

212 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would elderly individuals be eligible to participate in the trial?

"This medical trial specifies that the ages of participants should be between 6 months and 18 years old."

Answered by AI

To what extent is TARA-002 hazardous to health?

"After careful consideration, our team at Power has assigned TARA-002 a score of 2. This rating is due to the fact that while there are some safety evaluations conducted thus far, no efficacy studies have been done yet."

Answered by AI

Is it possible for me to join in this medical study?

"Candidates wishing to join this clinical trial must have lymphatic malformations and be between 6 months of age and 18. There are 38 positions available."

Answered by AI

Is recruitment of participants still underway for this investigation?

"Per clinicaltrials.gov, this trial is not accepting patients anymore; it was posted on October 1st 2023 and last updated September 29th 2023. Despite this study's closure, many other medical trials are open for participation at the moment - 120 in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05871970.