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

Not yet recruiting

• Conditions: Central Precocious Puberty

• Registration Number: NCT05341128
• Lead Sponsor: Takeda

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Study Start: 2025-05-31
• Primary Completion: 2025-12-30
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	From 07 August 2015 to 31 December 2022

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Change From Baseline in Decreased Ratio of Bone Age Over Chronological Age	Baseline up to 31 December 2022
Percentage of Participants With Change From Baseline in Decreased Ratio of Predicted Adult Height	Baseline up to 31 December 2022