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).
Source : Importé depuis le centre
RECRUTEMENT
Profil des participants
Limites d'âge
minimum : 5 ans
maximum : 8 ans
Sexe(s) des participants
ALL
Source : Importé depuis le centre
Condition médicale (spécialité visée)
Domaine de recherche
Donnée non disponible
Critères de sélection
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Debio 4326
Participants will receive the first injection of Debio 4326, on Day 1 in Part A followed by a second injection 52 weeks later in Part B of the study.
Donnée non disponible
Inconnu
Debio 4326
État du recrutement
unknown
Participants will receive the first injection of Debio 4326, on Day 1 in Part A followed by a second injection 52 weeks later in Part B of the study.
Données à jour depuis :
29 mars 2026
SITES ET CONTACTS
Centre principal
rady children's hospital - san diego
SAN DIEGO, CALIFORNIA, UNITED STATES
Recrutement local
—
FERMÉ
Aussi disponible à: CIUDAD AUTONOMA BUENOS AIRES, SAN FRANCISCO, (CALIFORNIA), BRASÍLIA, COLUMBIA, (SOUTH CAROLINA), PORTO ALEGRE, (RIO GRANDE DO SUL), ANTOFAGASTA, SANTIAGO, MAR DEL PLATA, (BUENOS AIRES), LAGO SUL, (BRASILIA DF), SÃO PAULO, VOTUPORANGA, (SÃO PAULO), ...
et 3 autres villes.
Dernière modification :
29 mars 2026
Données à jour depuis :
31 mars
Origine des données :
clinicaltrials.gov
Nous verifions auprès de chaque centre si des nouvelles informations sont disponibles
Identifiant
DEBIO 4326-301
Titre
A study to assess the efficacy, safety, and pharmacokinetics of debio 4326 in pediatric participants with central precocious puberty (libelula™ clinical trial)
1. Diagnosis of central precocious puberty.
2. 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.
3. Initially, only participants aged (a) 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 (b) 2 to 4 years inclusive (i.e., \<5 years) and/or (c) 9 to 10 years inclusive (i.e., \<11 years) may be recruited.
4. Participant to receive at least 1 year of gonadotropin-releasing hormone agonist (GnRHa) therapy from study treatment start.
5. (a) Pre-treated participants: Start of initial GnRHa therapy no later than 18 months after onset of the first signs of CPP.
(b) Treatment-naive participants: Start of Debio 4326 treatment no later than 18 months after onset of the first signs of CPP.
6. (a) Pre-treated participants: 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.
(b) Treatment-naive participants: Difference between bone age (Greulich and Pyle method) and chronological age of ≥1 year.
7. (a) Pre-treated participants: Pubertal-type LH response (LH ≥6 IU/L) following a GnRH/GnRHa stimulation test, or random non-stimulated serum LH \>0.5 IU/L (if considered local standard of care), based on historical values prior to the initiation of GnRHa therapy.
(b) Treatment-naive participants: Pubertal-type LH response (≥6 IU/L) 30 minutes following a GnRHa \[leuprolide acetate 20 micrograms per kilogram (μg/kg) subcutaneous injection (SC)\] stimulation test before treatment initiation.
8. (a) Pre-treated participants: Clinical evidence of puberty, defined as Tanner Staging ≥2 for breast development for girls and testicular volume ≥4 milliliter (mL) (cubic centimeter \[cc\]) for boys, prior to the initiation of GnRHa therapy.
(b) Treatment-naive participants: Clinical evidence of puberty, defined as Tanner Staging ≥2 for breast development for girls and testicular volume ≥4 mL (cc) for boys.
Exclusion Criteria:
1. Gonadotropin-independent (peripheral) precocious puberty: gonadotropin-independent gonadal or adrenal sex steroid secretion.
2. (a) Pre-treated participants: Non-progressing, isolated premature thelarche prior to the initial GnRHa therapy.
(b) Treatment-naive participants: Non-progressing, isolated premature thelarche.
3. Presence of an unstable intracranial tumor or an intracranial tumor potentially requiring neurosurgery or cerebral irradiation. Participants with hamartomas not requiring surgery are eligible.
4. Any other condition or chronic illness possibly interfering with growth (e.g., renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumor).
5. Other than GnRHa therapy in pre-treated participants, any ongoing treatment with a potential effect on serum levels of gonadotropins or sex steroids, or possibly interfering with growth, opioids, central nervous system \[CNS\] stimulants).
6. Prior or current therapy with medroxyprogesterone acetate, growth hormone, or Insulin-like growth factor-1 (IGF-1).
7. Diagnosis of short stature, i.e., more than 2.25 standard deviations (SD) below the mean height-for-age.
8. Known history of seizures, epilepsy, and/or central nervous system disorders that may have been associated with seizures or convulsions.
9. Prior (within 2 months of study treatment start) or current use of medications that have been associated with seizures or convulsions.
10. Use of anticoagulants (heparin or coumarin derivatives).
Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Debio 4326
Participants will receive the first injection of Debio 4326, on Day 1 in Part A followed by a second injection 52 weeks later in Part B of the study.
Donnée non disponible
Inconnu
Debio 4326
État du recrutement
unknown
Participants will receive the first injection of Debio 4326, on Day 1 in Part A followed by a second injection 52 weeks later in Part B of the study.
Données à jour depuis :
29 mars 2026
Description de l'étude
Description de l'étude
Résumé de l'étude
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).
Source : Importé depuis le centre
Centres participants
Sites
Centres participants
10
affichés
sur
15
centres
CENTRO DE INVESTIGACIONES MEDICAS MAR DEL PLATA
Mar del plata
BUENOS AIRES, ARGENTINA
Recrutement local
État du recrutement:
FERMÉ
CENTRO MEDICO DRA LAURA MAFFEI INVESTIGACION CLINICA APLICADA
Ciudad autonoma buenos aires
ARGENTINA
Recrutement local
État du recrutement:
FERMÉ
CHRISTUS LATAM HUB CENTER OF EXCELLENCE AND INNOVATION S C
Monterrey
MEXICO
Recrutement local
État du recrutement:
FERMÉ
CLÍNICA DE ENDOCRINOLOGIA E METABOLOGIA LTDA
Lago sul
BRASILIA DF, BRAZIL
Recrutement local
État du recrutement:
FERMÉ
CPQUALI PESQUISA CLINICA
São paulo
BRAZIL
Recrutement local
État du recrutement:
FERMÉ
ENDOMET
Antofagasta
CHILE
Recrutement local
État du recrutement:
FERMÉ
HOSPITAL CLINICO SAN BORJA ARRIARAN (HCSBA)
Santiago
CHILE
Recrutement local
État du recrutement:
FERMÉ
HOSPITAL DA CRIANÇA DE BRASÍLIA JOSE ALENCAR
Brasília
BRAZIL
Recrutement local
État du recrutement:
FERMÉ
INTEGRAL PESQUISA E ENSINO
Votuporanga
SÃO PAULO, BRAZIL
Recrutement local
État du recrutement:
FERMÉ
IRMANDADE SANTA CASA DE SÃO PAULO
São paulo
BRAZIL
Recrutement local
État du recrutement:
FERMÉ
Centres participants
Source d'information
Dernière modification :
29 mars 2026
Données à jour depuis :
31 mars
Origine des données :
clinicaltrials.gov
