Status:
RECRUITING
Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty
Lead Sponsor:
HanAll BioPharma Co., Ltd.
Conditions:
CPP
Eligibility:
All Genders
4-9 years
Phase:
PHASE4
Brief Summary
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 agr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06926933
Start Date
December 12 2024
End Date
October 30 2027
Last Update
April 15 2025
Active Locations (9)
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1
Korea University Ansan Hospital
Ansan, South Korea
2
Jeonbuk National University Hospital
Jeonju, South Korea
3
Chosun University Hospital
Kwangju, South Korea
4
Seoul National University Bundang Hospital
Seongnam, South Korea