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

February 9, 2024 updated by: Takeda

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100033
        • Not yet recruiting
        • Beijing Children's hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Bingyan Cao
    • Guangdong
      • Guangzhou, Guangdong, China, 510062
        • Not yet recruiting
        • the First A liated Hospital of Sun Yat-sen University
        • Principal Investigator:
          • Yanhong Li
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • The Hospital attached by the Torigji Medical College, Huazhong Science and Technology University.
        • Contact:
        • Principal Investigator:
          • Xiaoping Luo
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Provincial Hospital Affiliated to Shandong First Medical University
        • Contact:
        • Principal Investigator:
          • Yan Sun
    • Shanghai
      • Shanghai, Shanghai, China, 200062
        • Not yet recruiting
        • Shanghai Children's Hospital
        • Principal Investigator:
          • Pin Li
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 9 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Early appearance of secondary sexual characteristics: Girls ≤8 years, Boys ≤9years
  2. Body weight ≥20 kg
  3. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Leuprorelin Acetate Depot 3M 11.25 mg
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.
Drug: Leuprorelin Acetate Depot 3M
Leuprorelin Acetate Depot 3M SC injections.
Other Names:
  • Leuprolide acetate Depot 3M

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24
Time Frame: Week 24
The LH suppression is defined as LH peak value in GnRH stimulation ≤3.0 international unit per liter (IU/L).
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Tanner Stage Regression or No Progression at Week 24
Time Frame: Baseline and 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.
Baseline and Week 24
Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
Time Frame: Baseline, Week 24 and 36
Plasma LH and FSH peak concentrations under GnRH stimulation will be assessed.
Baseline, Week 24 and 36
Percentage of Participants With Decreased Ratio of Bone Age Over Chronological Age at Week 24
Time Frame: Baseline and Week 24
Bone age will be determined by Greulich and Pyle standards or Tanner-Whitehouse 3 (TW3) standards.
Baseline and Week 24
Percentage of Participants with Decreased First Morning Voided (FMV) Urinary Gonadotropin (Gn) at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
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)
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.
From first dose of study drug up to 12 weeks post last dose or early termination Visit (ET) (Up to approximately 38 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2023

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Leuprorelin-4002
  • 2022-002471-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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