A Study of Medical Records From Children With Central Precocious Puberty (CPP) in China (PACTURE)

January 16, 2026 updated by: Takeda

Patient Characteristics, Treatment Patterns, and Resource Usage in Children Diagnosed With Central Precocious Puberty (CPP) in China

The main purpose is to describe how many children were treated during 24 months or less because of CPP and how treatment worked for them.

There are no participants in this trial, the study only involves reviewing participants medical past and current records and collecting information.

Study Overview

Status

Completed

Conditions

Detailed Description

This is an observational, non-interventional, retrospective study to evaluate the participants characteristics, current treatment patterns and resource usage in Chinese pediatric participants diagnosed with CPP.

This study will enroll approximately 1000 participants.

The data available in an existing data source the Chinese CPP Big Data Platform database will be analyzed. All the participants will be assigned to a single observational cohort:

• Pediatric Participants With CPP

This multi-center trial will be conducted in China. The overall duration of the study will be approximately 3 years.

Study Type

Observational

Enrollment (Actual)

1477

Contacts and Locations

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

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530007
        • The Second Affiliated Hospital of Guangxi Medical University
    • Hainan
      • Haikou, Hainan, China, 570206
        • Hainan Women and Children's Medical Center
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Tianjin Medical University General Hospital

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 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric participants with a diagnosis of CPP who are currently or previously undergoing GnRHa treatment between 2015 and 31 December 2024 will be enrolled in this study.

Description

Inclusion Criteria:

• Participants diagnosed with CPP and treated with GnRHa from the centers participating in this study within the Chinese CPP Big Data Platform database since 2015 to 2024.

CPP diagnosis is based on the clinical assessment and description by CPP specialized doctors.

Exclusion Criteria:

  • Not received GnRHa as the treatment for CPP.
  • No available data for analysis.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
All Participants With CPP
Pediatric participants who have been diagnosed with CPP, who are currently or previously undergoing with gonadotropin-releasing hormone agonist (GnRHa) treatment between 2015, and 31 December 2024 will be assessed retrospectively using the Chinese CPP Big Data Platform database.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With CPP Treatment
Time Frame: Up to approximately 10 years
Up to approximately 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With CPP Treatment at Baseline
Time Frame: At Baseline
At Baseline
Percentage of Participants With Luteinizing hormone (LH) Suppression
Time Frame: Baseline up to approximately 10 years
Baseline up to approximately 10 years
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 10 years
Up to approximately 10 years

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)

December 13, 2023

Primary Completion (Actual)

August 27, 2025

Study Completion (Actual)

August 27, 2025

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Leuprorelin-5007

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
  • 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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