Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty (NEST)

HanAll Biopharma

Status and phase

Enrolling

Phase 4

Conditions

CPP

Treatments

Drug: Eligard® 45 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT06926933

HLA24IV_1

Details and patient eligibility

About

This study is a multicenter, open-label, single-group, and phase 4 study to evaluate the efficacy and safety of 45 mg of leuprolide acetate in CPP.

Screening tests are performed after the subject agrees in writing to participate in the clinical trial, and subjects who meet the inclusion criteria and do not fall under the exclusion criteria are enrolled in the study. The target patients in this study are pediatric patients who have been diagnosed with CPP but have not yet received GnRH agonist treatment, and all subjects perform GnRH stimulation tests to confirm their CPP diagnosis.

Enrollment

50 estimated patients

Sex

All

Ages

4 to 9 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Pubertal-type LH response following an abbreviated GnRH stimulation test before treatment initiation > 5 IU/L
A subject manifested with central precocious puberty according to the following criteria Age : Boy (4 years of age or older ~ under 9 years of age) Girl (4 years of age or older ~ under 8 years of age) Tanner Stage : Level 2 or higher
Based on baseline visit (Day 0), those under the age of 10 for boys and those under the age of 9 for girls
Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP
Children with a body weight of more than 20 kg at screening
Children have a bone age that is ≥1 year older than their chronological age at screening
A signed written consent form by a legal representative who has been informed about this study

Exclusion criteria

Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion
Prior or current GnRH treatment for CPP
Non-progressing isolated premature thelarche
Presence of an unstable intracranial tumor or an intracranial tumor requiring neurosurgery or cerebral irradiation. Subjects with hamartomas not requiring surgery are eligible.
Prior (within 12 weeks of Screening) use of medications
- Hormonal agonists (Estrogen, Progesterone, FSH, LH, Testosterone etc.)
- Hormonal antagonists (Anti-Estrogen agents, Anti-Androgen agents)
- Steroid use (except for mild topical steroids, oral steroids are allowed within 30 days)
- Herbal Medicines
Prior or current therapy with growth hormone
Major medical or psychiatric illness that could interfere with study visits
Diagnosis of short stature (i.e. 2 standard deviations (SD) below the mean height for age or 3rd percentile for age)
Pregnant or likely pregnant women (Positive urine pregnancy test), nursing women
Known hypersensitivity to GnRH or related compounds
Any other medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the subject to participate in the study
Any other condition(s) which could significantly interfere with Protocol compliance
Treatment with an investigational product within 5 half-lives of that product in prior clinical studies before the baseline visit (Day 0)
Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions
Prior (within 6 months of Baseline (Day 0)) or current use of medications that, per investigator opinion, have been associated with seizures or convulsions