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NCT05871970 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Lymphatic Malformation, sponsored by Protara Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 10
- Study locations
NCT05871970 is a Phase 2 study of Lymphatic Malformation that is actively recruiting participants, run by Protara Therapeutics. The registered enrollment target is 38 participants. The trial reports 10 study locations across 10 states.
The verdict
NCT05871970, a Phase 2 study of Lymphatic Malformation, is actively recruiting participants, sponsored by Protara Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 10
- Study locations
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL TARA-002
Study Locations (10)
Alabama
- Children's Hospital of Alabama - Birmingham
Arkansas
- Arkansas Children's Hospital/UAMS - Little Rock
Colorado
- Children's Hospital of Colorado - Aurora
District of Columbia
- Children's National Medical Center: Children's Research Institute - Washington D.C.
Florida
- Nemours Children's Clinic - Jacksonville - Jacksonville
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Oregon
- Oregon Health & Science University - Portland
Pennsylvania
- Children's Hospital of Philadelphia: Comprehensive Vascular Anomalies Program - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2023-10-18 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05871970
The ClinicalTrials.gov registry entry for NCT05871970 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Protara Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lymphatic Malformation appearing as the primary indexed condition, and to 1 intervention - of which TARA-002 is the first listed.
NCT05871970 reports 10 study locations spanning 10 distinct geographic areas - top geographies include Alabama, Arkansas, Colorado.
Frequently Asked Questions
What is clinical trial NCT05871970 about?
NCT05871970 is a clinical study titled "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". 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...
What is the current status of trial NCT05871970?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2023-10-18. Estimated completion is 2026-05.
What conditions does trial NCT05871970 study?
This clinical trial studies the following conditions: Lymphatic Malformation.
What interventions are being tested in trial NCT05871970?
The interventions under investigation include: TARA-002 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05871970?
This trial is sponsored by Protara Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05871970 being conducted?
This trial has 10 study locations across Alabama, Arkansas, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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