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NCT06129539 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
A Phase 3 study of Central Precocious Puberty, sponsored by Debiopharm International.
- Active
- Registry status
- Phase 3
- Development phase
- 56
- Enrollment target
- 20
- Study locations
NCT06129539 is a Phase 3 study of Central Precocious Puberty that is active but no longer recruiting, run by Debiopharm International. The registered enrollment target is 56 participants. The trial reports 20 study locations across 7 states.
The verdict
NCT06129539, a Phase 3 study of Central Precocious Puberty, is active but no longer recruiting, sponsored by Debiopharm International.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 56 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to evaluate the efficacy of Debio 4326 in suppressing serum luteinizing hormone (LH) to prepubertal levels 52 weeks after the first Debio 4326 injection in pediatric participants with central precocious puberty (CPP).
Conditions Studied
Interventions
- DRUG Debio 4326
Study Locations (20)
Other
- Instituto de Investigaciones Metabolicas (IDIM) - Buenos Aires
- Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada - Buenos Aires
- Centro de Investigaciones Medicas Mar del Plata - Mar del Plata
- Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L - San Miguel de Tucumán
- Hospital Da Criança de Brasília Jose Alencar - Brasília
- Hospital Universitario Walter Cantidio - Fortaleza
- Clínica de Endocrinologia e Metabologia Ltda - Lago Sul
- Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS - Porto Alegre
- CPQuali Pesquisa Clinica - São Paulo
- Irmandade Santa Casa de São Paulo - São Paulo
- Integral Pesquisa e Ensino - Votuporanga
- ENDOMET - Antofagasta
California
- Rady Children's Hospital - San Diego - San Diego
- University of California San Francisco-Benioff Children's Hospital - San Francisco
Texas
- University of Texas Southwestern Medical Center - Dallas
- Texas Children's Hospital - Houston
Indiana
- Indiana University/Riley Hospital for Children - Indianapolis
Missouri
- Washington University - St Louis
South Carolina
- Prisma Health Pediatric Endocrinology - Columbia
Virginia
- Virginia Commonwealth University Health System - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2024-07-31 |
| Est. Completion | 2028-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06129539
The ClinicalTrials.gov registry entry for NCT06129539 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Debiopharm International, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Central Precocious Puberty appearing as the primary indexed condition, and to 1 intervention - of which Debio 4326 is the first listed.
NCT06129539 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, California, Texas.
Frequently Asked Questions
What is clinical trial NCT06129539 about?
NCT06129539 is a clinical study titled "A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)". The primary objective of this study is to evaluate the efficacy of Debio 4326 in suppressing serum luteinizing hormone (LH) to prepubertal levels 52 weeks after the first Debio 4326 injection in pediatric participants with central precocious puberty (CPP).
What is the current status of trial NCT06129539?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 56 participants. The study started on 2024-07-31. Estimated completion is 2028-02.
What conditions does trial NCT06129539 study?
This clinical trial studies the following conditions: Central Precocious Puberty.
What interventions are being tested in trial NCT06129539?
The interventions under investigation include: Debio 4326 (DRUG).
Who is sponsoring clinical trial NCT06129539?
This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06129539 being conducted?
This trial has 20 study locations across California, Indiana, Missouri, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.