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A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty

Primary Purpose

Central Precocious Puberty

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Leuprorelin Acetate Depot 3M

About this trial

This is an interventional treatment trial for Central Precocious Puberty focused on measuring Drug Therapy

Eligibility Criteria

undefined - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Early appearance of secondary sexual characteristics: Girls ≤8 years, Boys≤9years
Body weight ≥20 kg
According to the National Consensus Statement in China (2015), CPP is diagnosed when secondary sexual characteristics appeared before the age of 8 years in girls and 9 years in boys, a peak LH level > 5.0 IU/L with LH/FSH > 0.6 in stimulating test; evidence of gonadal development by ultrasonography (multiple ovarian follicles ≥ 4 mm in any ovary or uterine enlargement in females or testicular volume ≥ 4 mL in males); advanced bone age (BA) ≥ 1 year; linear growth acceleration with higher growth velocity (GV) than normal children. BA is determined by Greulich and Pyle standards or TW3 standards at screening.

Exclusion Criteria:

The participant has received GnRHa treatment in a previous clinical study or as a therapeutic agent.
The participant has a history or clinical manifestations of significant adrenal or thyroid diseases or intracranial tumor OR has a history of malignant disease.
The participant has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound.
The participant has a diagnosis of peripheral precocious puberty.

Sites / Locations

Beijing Children's Hospital, Capital Medical University
the First A liated Hospital of Sun Yat-sen University
The Hospital attached by the Torigji Medical College, Huazhong Science and Technology University.
Provincial Hospital Affiliated to Shandong First Medical UniversityRecruiting
Shanghai Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Leuprorelin Acetate Depot 3M 11.25 mg

Arm Description

Participants with CPP having body weight ≥20 kg will receive the recommended dose of leuprorelin acetate depot 11.25 mg subcutaneous administration (SC) every 12 weeks based on the standard of 30～180ug/kg/4weeks for the 24-week Treatment Period. It is not recommended to exceed the dose above 180 μg/kg.

Outcomes

Primary Outcome Measures

Percentage of Participants with Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24

The LH suppression is defined as LH peak value in GnRH stimulation ≤3.0 international unit per liter (IU/L).

Secondary Outcome Measures

Percentage of Participants with Tanner Stage Regression or No Progression at Week 24

Tanner Stage is used to measure pubertal development. Tanner Stage is based on progression through 5-stages. The progression was defined that either breast/genitals or pubic hair score had increased score compared with baseline score. Otherwise, the status was classified as regression or no progression. Baseline is defined as the assessment prior to the first dose of study drug.

Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)

Plasma LH and FSH peak concentrations under GnRH stimulation will be assessed.

Percentage of Participants With Decreased Ratio of Bone Age Over Chronological Age at Week 24

Bone age will be determined by Greulich and Pyle standards or Tanner-Whitehouse 3 (TW3) standards.

Percentage of Participants with Decreased First Morning Voided (FMV) Urinary Gonadotropin (Gn) at Week 24

Number of Participants With Treatment-Emergent Adverse Events (TEAE)

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

Full Information

NCT ID

NCT05341115

First Posted

April 18, 2022

Last Updated

August 24, 2023

Sponsor

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT05341115

Brief Title

A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty

Official Title

An Open Label, Multicenter, Single-arm and Prospective Study to Assess the Efficacy and Safety of Leuprorelin 3M in the Treatment of Central Precocious Puberty (CPP)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 14, 2023 (Actual)

Primary Completion Date

January 30, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The main aim is to see how leuprolide works to treat central precocious puberty in children. Participants will receive an injection of leuprorelin acetate depot 11.25 mg every 12 weeks during 6 months and will visit their study clinic 6 times to complete some assessments.

Detailed Description

The drug being tested in this study is called leuprorelin acetate depot 3M. Leuprorelin acetate depot 3M will be tested to treat children who have central precocious puberty. This study will look at the efficacy and safety of leuprorelin acetate depot 3M in the treatment of CPP. The study will enroll approximately 80 participants with CPP. Participants with a bodyweight of ≥ 20 kg will receive the recommended dose of leuprorelin acetate depot 3M in a 24 weeks Treatment Period followed by a 12 weeks Post-treatment follow-up period. Participants will be assigned to the following drug administration: • Leuprorelin Acetate Depot 3M 11.25 mg Participants will receive leuprorelin acetate depot 3M 11.25 mg as subcutaneous (SC) injection on Weeks 0, 12, and 24. The gonadotropin-releasing hormone agonist (GnRHa) stimulation, basal luteinizing hormone (LH), and follicle-stimulating hormone (FSH) levels will be tested pre-dose of every SC injection of the study drug or at premature termination. This multi-center trial will be conducted in China. The overall time to participate in this study is 38 weeks. Participants will make a follow-up visit to the site at approximately 12 weeks after the last dose of study treatment.

6. Conditions and Keywords

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

Central Precocious Puberty

Keywords

Drug Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Leuprorelin Acetate Depot 3M 11.25 mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Leuprorelin Acetate Depot 3M

Other Intervention Name(s)

Leuprolide acetate Depot 3M

Intervention Description

Leuprorelin Acetate Depot 3M SC injections.

Primary Outcome Measure Information:

Title

Percentage of Participants with Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24

Description

The LH suppression is defined as LH peak value in GnRH stimulation ≤3.0 international unit per liter (IU/L).

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

Percentage of Participants with Tanner Stage Regression or No Progression at Week 24

Description

Time Frame

Baseline and Week 24

Title

Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)

Description

Plasma LH and FSH peak concentrations under GnRH stimulation will be assessed.

Time Frame

Baseline, Week 24 and 36

Title

Percentage of Participants With Decreased Ratio of Bone Age Over Chronological Age at Week 24

Description

Bone age will be determined by Greulich and Pyle standards or Tanner-Whitehouse 3 (TW3) standards.

Time Frame

Baseline and Week 24

Title

Percentage of Participants with Decreased First Morning Voided (FMV) Urinary Gonadotropin (Gn) at Week 24

Time Frame

Baseline and Week 24

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAE)

Description

Time Frame

From first dose of study drug up to 12 weeks post last dose or early termination Visit (ET) (Up to approximately 38 weeks)

10. Eligibility

Sex

All

Maximum Age & Unit of Time

9 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Early appearance of secondary sexual characteristics: Girls ≤8 years, Boys ≤9years Body weight ≥20 kg According to the National Consensus Statement in China (2015), CPP is diagnosed when secondary sexual characteristics appeared before the age of 8 years in girls and 9 years in boys, a peak LH level >5.0 IU/L with LH/FSH >0.6 in stimulating test; evidence of gonadal development by ultrasonography (multiple ovarian follicles ≥4 mm in any ovary or uterine enlargement in females or testicular volume ≥4 mL in males); advanced bone age (BA) ≥1 year; linear growth acceleration with higher growth velocity (GV) than normal children. BA is determined by Greulich and Pyle standards or TW3 standards at screening. Exclusion Criteria: The participant has received GnRHa treatment in a previous clinical study or as a therapeutic agent. The participant has a history or clinical manifestations of significant adrenal or thyroid diseases or intracranial tumor OR has a history of malignant disease. The participant has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound. The participant has a diagnosis of peripheral precocious puberty.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Takeda Contact

Phone

+1-877-825-3327

medinfoUS@takeda.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

Facility Name

Beijing Children's Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100033

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

13811748954

caoby1982@163.com

First Name & Middle Initial & Last Name & Degree

Bingyan Cao

Facility Name

the First A liated Hospital of Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510062

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

13922335431

lyhsysu@vip.163.com

First Name & Middle Initial & Last Name & Degree

Yanhong Li

Facility Name

The Hospital attached by the Torigji Medical College, Huazhong Science and Technology University.

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

13387522645

xpluo@tjh.tjmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Xiaoping Luo

Facility Name

Provincial Hospital Affiliated to Shandong First Medical University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

15168889589

sunyan6150@126.com

First Name & Middle Initial & Last Name & Degree

Yan sun

Facility Name

Shanghai Children's Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200062

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

13816287308

lipin21@126.com

First Name & Middle Initial & Last Name & Degree

Pin Li

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing URL

https://vivli.org/ourmember/takeda/

Links:

URL

https://clinicaltrials.takeda.com/study-detail/137c315e3a744cda?idFilter=%5B%22Leuprorelin-4002%22%5D

Description

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A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty

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