CPP
Conditions
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 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.
Interventions
DRUGEligard® 45 mg
45 mg of leuprolide acetate
Sponsors
HanAll BioPharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
1. Pubertal-type LH response following an abbreviated GnRH stimulation test before treatment initiation \> 5 IU/L 2. 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 3. Based on baseline visit (Day 0), those under the age of 10 for boys and those under the age of 9 for girls 4. Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP 5. Children with a body weight of more than 20 kg at screening 6. Children have a bone age that is ≥1 year older than their chronological age at screening 7. A signed written consent form by a legal representative who has been informed about this study
Exclusion criteria
1. Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion 2. Prior or current GnRH treatment for CPP 3. Non-progressing isolated premature thelarche 4. Presence of an unstable intracranial tumor or an intracranial tumor requiring neurosurgery or cerebral irradiation. Subjects with hamartomas not requiring surgery are eligible. 5. 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 6. Prior or current therapy with growth hormone 7. Major medical or psychiatric illness that could interfere with study visits 8. Diagnosis of short stature (i.e. 2 standard deviations (SD) below the mean height for age or 3rd percentile for age) 9. Pregnant or likely pregnant women (Positive urine pregnancy test), nursing women 10. Known hypersensitivity to GnRH or related compounds 11. 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 12. Any other condition(s) which could significantly interfere with Protocol compliance 13. Treatment with an investigational product within 5 half-lives of that product in prior clinical studies before the baseline visit (Day 0) 14. Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions 15. Prior (within 6 months of Baseline (Day 0)) or current use of medications that, per investigator opinion, have been associated with seizures or convulsions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage (%) of subjects with serum LH concentrations < 4 IU/L following an GnRH stimulation test | at week 24 | Blood samples for serum LH concentrations (as appropriate) will be collected at the appropriate assessment times and analyzed by a central laboratory. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage (%) of subjects with suppressed serum LH concentrations (< 4 IU/L) 30-minutes post GnRH stimulation test | at week 12, 48, 72, 96 | Blood samples for serum LH concentrations (as appropriate) will be collected at the appropriate assessment times and analyzed by a central laboratory. |
| The percentage (%) of subjects with suppressed serum FSH (< 2.5 mIU/mL), estradiol (< 20 pg/mL, for girl) or testosterone (< 30 ng/dL, for boy) | at week 12, 24, 48, 72, 96 | Sexual development in puberty will be assessed by Tanner staging |
| The percentage of subject of Tanner stage (including menstruation) | at week 12, 24, 48, 72, 96 | Sexual development in puberty will be assessed by Tanner staging |
| Height velocity (growth rate) | at week 12, 24, 48, 72, 96 | Annualized Height Velocity |
| The ratio of bone age and chronological age | at week 12, 24, 48, 72, 96 | A single X-ray of the non-dominant hand and wrist will be obtained periodically |
Countries
South Korea
Contacts
STUDY_DIRECTOREunhee Lee
Hanall Biopharma
Outcome results
None listed