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

February 22, 2024 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

Not yet recruiting

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 400 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 18 months.

Study Type

Observational

Enrollment (Estimated)

400

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

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 as per 2015 version of the Consensus on the Diagnosis and Treatment of Central Precocious Puberty and who have received treatment or medical services in China between 07 August 2015 and 31 December 2024 will be enrolled in this study.

Description

Inclusion Criteria:

  • The CPP database already includes participants with CPP diagnosed according to the 2015 version of The Consensus on the Diagnosis and Treatment of Central Precocious Puberty. All patients in the database are eligible CPP participants.

Exclusion Criteria:

  • Participants with CPP due to identified etiology such as tumors, exogenous factors, congenital adrenal hyperplasia (CAH), and Mccune-Albright syndrome, hepatopathy, nephropathy, congenital heart disease, and hereditary metabolic diseases will be excluded.

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
Pediatric Participants With CPP
Pediatric participants who have been diagnosed with CPP per criteria set in the 2015 version of The Consensus on the Diagnosis and Treatment of Central Precocious Puberty and have received treatment or medical services in China between 07 August 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 Treatment-emergent Adverse Events (TEAEs)
Time Frame: From 07 August 2015 to 31 December 2022
From 07 August 2015 to 31 December 2022

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Change From Baseline in Decreased Ratio of Bone Age Over Chronological Age
Time Frame: Baseline up to 31 December 2022
Baseline up to 31 December 2022
Percentage of Participants With Change From Baseline in Decreased Ratio of Predicted Adult Height
Time Frame: Baseline up to 31 December 2022
Baseline up to 31 December 2022

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 (Estimated)

May 31, 2025

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

February 28, 2026

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 (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

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
  • 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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