Last updated 30 days ago
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Debio 4326 in Pediatric Participants Receiving Gonadotropin-Releasing Hormone Agonist Therapy for Central Precocious Puberty
53 patients around the world
Available in Chile, Brazil, Argentina, Mexico
Debiopharm International SA
17Research sites
53Patients around the world
This study is for people with
Pubertal Development Disorder
Central Precocious Puberty
Requirements for the patient
To 8 Years
All Gender
Medical requirements
- Diagnosis of central precocious puberty and currently receiving GnRHa therapy.Onset of development of sex characteristics (i.e., breast development in girls or testicular enlargement in boys according to the Tanner method) before the age of 8 years in girls and 9 years in boys.Initially, only participants aged 5 to 8 years inclusive (i.e., <9 years) are eligible.The Sponsor will determine based on the recommendation of the DMC following the interim analysis whether participants aged 2 to 4 years inclusive (i.e., <5 years) and/or 9 to 10 years inclusive (i.e., <11 years) may be recruited.Participant to receive at least 1 year of GnRHa therapy from study treatment start.Start of initial GnRHa therapy no later than 18 months after onset of the first signs of Central precocious puberty (CPP).Difference between bone age (Greulich and Pyle method) and chronological age of ≥1 year based on historical values at the initiation of the GnRHa therapy.Pubertal-type LH response following a GnRH/GnRHa stimulation test, or random non-stimulated serum (if considered local standard of care), based on historical values prior to the initiation of GnRHa therapy.Clinical evidence of puberty, defined as Tanner Staging ≥2 for breast development for girls and testicular volume ≥4 mL (cc) for boys, prior to the initiation of GnRHa therapy.
- Gonadotropin-independent (peripheral) precocious puberty: gonadotropin-independent gonadal or adrenal sex steroid secretion.Non-progressing, isolated premature thelarche prior to the initial GnRHa therapy.Presence of an unstable intracranial tumor or an intracranial tumor potentially requiring neurosurgery or cerebral irradiation.Participants with hamartomas not requiring surgery are eligible.Any other condition or chronic illness possibly interfering with growth (e.g., renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumor).Other than GnRHa therapy, any ongoing treatment with a potential effect on serum levels of gonadotropins or sex steroids, or possibly interfering with growth.Prior or current therapy with medroxyprogesterone acetate, growth hormone, or Insulin-like growth factor-1 (IGF-1).Diagnosis of short stature, i.e., more than 2.25 standard deviations (SD) below the mean height-for-age.Known history of seizures, epilepsy, and/or central nervous system disorders that may have been associated with seizures or convulsions.Prior (within 2 months of study treatment start) or current use of medications that have been associated with seizures or convulsions.Use of anticoagulants (heparin or coumarin derivatives).
Sites
Clínica Mayo de UMCB SRL
Recruiting
Centro Médico Maffei - CABA, Buenos Aires
Recruiting
Universidade Federal do Pará
Hospital Universitário Walter Cantídio - Universidade Federal do Ceará - Fortaleza, Ceara
Recruiting
Núcleo de Pesquisa Clínica do Rio Grande do Sul - NPCRS
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
CPClin – Centro de Pesquisas Clinicas LTDA
Recruiting
Instituto Pesquisa e Ensino em Saúde Infantil - PENSI
Recruiting
CPQuali Pesquisa Clínica
Recruiting
Irmandade da Santa Casa de Misericórdia de São Paulo - Hospital Central
Recruiting
StudyLIBELULA
SponsorDebiopharm International SA
Study typeInterventional
Conditions
Central Precocious Puberty
Requirements
To 8 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06129539
