A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)

PHASE3RecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

July 31, 2024

Primary Completion Date

November 30, 2026

Study Completion Date

February 29, 2028

Conditions
Central Precocious Puberty
Interventions
DRUG

Debio 4326

Administered as an intramuscular (IM) injection

Trial Locations (37)

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

10467

RECRUITING

Children's Hospital at Montefiore, New York

19104

RECRUITING

Investigational Drug Service, The Children's Hospital of Philadelphia, Philadelphia

23298

RECRUITING

Virginia Commonwealth University Health System, Richmond

29203

RECRUITING

Prisma Health Pediatric Endocrinology, Columbia

30318

RECRUITING

Atlanta Diabetes Associates, Atlanta

32207

RECRUITING

Wolfson's Children's Hospital, Jacksonville

32514

RECRUITING

Nemours Children's Health, Pensacola

44224

RECRUITING

Akron Children's Hospital, Akron

46202

RECRUITING

Indiana University/Riley Hospital for Children, Indianapolis

48109

RECRUITING

University of Michigan, Ann Arbor

60611

RECRUITING

Ann and Robert H.Lurie Children's Hospital of Chicago, Chicago

63110

RECRUITING

Washington University, St Louis

64060

RECRUITING

Christus Latam Hub Center of Excellence and Innovation S C, Monterrey

72190

NOT_YET_RECRUITING

Hospital Angeles Puebla, Puebla City

75231

RECRUITING

Research Institute of Dallas, Dallas

75235

RECRUITING

University of Texas Southwestern Medical Center, Dallas

77030

RECRUITING

Texas Children's Hospital, Houston

85712

RECRUITING

TMC HealthCare, Tucson

92123

RECRUITING

Rady Children's Hospital - San Diego, San Diego

94143

RECRUITING

University of California San Francisco-Benioff Children's Hospital, San Francisco

1271987

RECRUITING

ENDOMET, Antofagasta

8360160

RECRUITING

Hospital Clinico San Borja Arriaran (HCSBA), Santiago

71625175

RECRUITING

Clínica de Endocrinologia e Metabologia Ltda, Lago Sul

C1012AAR

RECRUITING

Instituto de Investigaciones Metabolicas (IDIM), Buenos Aires

C1425AGC

RECRUITING

Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada, Buenos Aires

B7600FYK

RECRUITING

Centro de Investigaciones Medicas Mar del Plata, Mar del Plata

T4000

RECRUITING

Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L, San Miguel de Tucumán

70684-831

RECRUITING

Hospital Da Criança de Brasília Jose Alencar, Brasília

80030-110

RECRUITING

CETI - Centro de Estudos em Terapias Inovadoras Ltda, Curitiba

60430-270

RECRUITING

Hospital Universitario Walter Cantidio, Fortaleza

90430-001

RECRUITING

Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS, Porto Alegre

15090-000

RECRUITING

Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto

01228-200

RECRUITING

CPCLIN - Centro de Pesquisas Clínicas Ltda., São Paulo

01228000

RECRUITING

CPQuali Pesquisa Clinica, São Paulo

REG1 01222-020

RECRUITING

Irmandade Santa Casa de São Paulo, São Paulo

15501-405

RECRUITING

Integral Pesquisa e Ensino, Votuporanga

Sponsors
All Listed Sponsors
lead

Debiopharm International SA

INDUSTRY