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Evaluate the Efficacy and Safety of DWJ108J

Primary Purpose

Central Precocious Puberty

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Leuprolide Acetate 11.25 MG/ML
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Precocious Puberty

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Exhibited pubertal response of LH (peak ≥ 5 IU/L) during GnRH stimulation test at screening Diagnosis of central precocious puberty For boys, those under 10 years old and for girls, those under 9 years old, based on Visit 2 (Enrollment), with Tanner Stage 2 or above Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year In cases where the legal guardian of the child listened to the explanation of this clinical trial and provided written consent Exclusion Criteria: Following conditions at Visit 1(Screening) : Conditions related to pseudo precocious puberty, Incomplete precocious puberty, Dysfunction of pituitary, adrenal, thyroid, or reproductive glands, Growth disorders or bone diseases that could affect bone growth, Brain tumor, Pituitary adenoma requires treatment within 6 months of receiving a registration number during the trial period that could affect the hypothalamic-pituitary-gonadal axis Prior treatment with GnRH analogues Hypersensitive to the investigational drug for this clinical trial or GnRH analogues Prior or current therapy with growth hormone has taken the following medications within 8 weeks of Visit 1 (Screening): Sex hormone medications, Sex hormone antagonists, Steroids (local application is allowed; oral formulations are not allowed if taken within 3 days continuously, and use within 2 weeks of screening is prohibited), Herbal medicine Meets the following criteria based on screening test results: AST, ALT levels exceed twice the upper limit of normal, Creatinine levels exceed 1.5 times the upper limit of normal, Bone age is above 11.5 years 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

Sites / Locations

  • Ajou University medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Leuprorelin

Arm Description

Participants with body weight greater than or equal to (≥) 20 kilogram (kg) will receive the recommended dose of leuprorelin 11.25 milligram (mg), injection, subcutaneously, once every 3 months for 6 months. Participants with body weight less than (<) 20 kg will receive leuprorelin 5.625 mg, injection, subcutaneously, once every 3 months for 6 months.

Outcomes

Primary Outcome Measures

Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.

Secondary Outcome Measures

Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 3 Months.
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.
Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.
Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.
Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration
Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration
Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.
Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.
Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.
Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.
Average Tanner Stage at 6 months after administration, and the changes compared to before administration.
Average Tanner Stage at 6 months after administration, and the changes compared to before administration.
Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.
Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.

Full Information

First Posted
August 29, 2023
Last Updated
August 29, 2023
Sponsor
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT06025409
Brief Title
Evaluate the Efficacy and Safety of DWJ108J
Official Title
A Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWJ108J in Patients With Central Precocious Puberty : A Single-arm, Open-label, Multi-center, Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg) in patients with central precocious puberty.
Detailed Description
The drug in this study is called leuprorelin. It is administered as a 3 month subcutaneous depot injection. Leuprorelin is used to treat children who have Central Precocious Puberty. This study will look at whether leuprorelin can stop early Central Precocious Puberty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Precocious Puberty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Leuprorelin
Arm Type
Experimental
Arm Description
Participants with body weight greater than or equal to (≥) 20 kilogram (kg) will receive the recommended dose of leuprorelin 11.25 milligram (mg), injection, subcutaneously, once every 3 months for 6 months. Participants with body weight less than (<) 20 kg will receive leuprorelin 5.625 mg, injection, subcutaneously, once every 3 months for 6 months.
Intervention Type
Drug
Intervention Name(s)
Leuprolide Acetate 11.25 MG/ML
Intervention Description
Subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.
Description
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 3 Months.
Description
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.
Time Frame
3 months
Title
Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.
Description
Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.
Time Frame
Baseline, 3 and 6 months
Title
Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration
Description
Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration
Time Frame
3 and 6 months
Title
Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.
Description
Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.
Time Frame
Baseline, 3 and 6 months
Title
Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.
Description
Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.
Time Frame
6 months
Title
Average Tanner Stage at 6 months after administration, and the changes compared to before administration.
Description
Average Tanner Stage at 6 months after administration, and the changes compared to before administration.
Time Frame
6 months
Title
Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.
Description
Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Exhibited pubertal response of LH (peak ≥ 5 IU/L) during GnRH stimulation test at screening Diagnosis of central precocious puberty For boys, those under 10 years old and for girls, those under 9 years old, based on Visit 2 (Enrollment), with Tanner Stage 2 or above Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year In cases where the legal guardian of the child listened to the explanation of this clinical trial and provided written consent Exclusion Criteria: Following conditions at Visit 1(Screening) : Conditions related to pseudo precocious puberty, Incomplete precocious puberty, Dysfunction of pituitary, adrenal, thyroid, or reproductive glands, Growth disorders or bone diseases that could affect bone growth, Brain tumor, Pituitary adenoma requires treatment within 6 months of receiving a registration number during the trial period that could affect the hypothalamic-pituitary-gonadal axis Prior treatment with GnRH analogues Hypersensitive to the investigational drug for this clinical trial or GnRH analogues Prior or current therapy with growth hormone has taken the following medications within 8 weeks of Visit 1 (Screening): Sex hormone medications, Sex hormone antagonists, Steroids (local application is allowed; oral formulations are not allowed if taken within 3 days continuously, and use within 2 weeks of screening is prohibited), Herbal medicine Meets the following criteria based on screening test results: AST, ALT levels exceed twice the upper limit of normal, Creatinine levels exceed 1.5 times the upper limit of normal, Bone age is above 11.5 years 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yeonseo Choi, MD. PhD
Phone
82-2-550-8800
Email
yeonseo@daewoong.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Soong Hwang, MD. PhD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University medical center
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Soon Hwang
Phone
82-1688-6114
Email
yeonseo@daewoong.co.kr

12. IPD Sharing Statement

Plan to Share IPD
No

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