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

Takeda

Status: Completed

Conditions: Central Precocious Puberty

Study type: Observational

Funder types: Industry

Identifiers

NCT05341128

Leuprorelin-5007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,477 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,477 participants in 1 patient group

All Participants With CPP

Description:

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.