Clinical trial NCT05341128: A Study of Medical Records From Children With Central Precocious Puberty (CPP) in China
Official title: Patient Characteristics, Treatment Patterns, and Resource Usage in Children Diagnosed With Central Precocious Puberty (CPP) in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Precocious Puberty
Keywords: Central Precocious Puberty
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-04-22
Enrollment: 1000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With CPP Treatment
timeFrame: Up to approximately 10 years
Secondary outcomes:
measure: Percentage of Participants With CPP Treatment at Baseline
timeFrame: At Baseline
measure: Percentage of Participants With Luteinizing hormone (LH) Suppression
timeFrame: Baseline up to approximately 10 years
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 10 years
Other outcomes:
Locations:
city: Nanning
country: China
facility: The Second Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Haikou
country: China
facility: Hainan Women and Children's Medical Center
state: Hainan
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
state: Hubei
city: Jinan
country: China
facility: Shandong Provincial Hospital Affiliated to Shandong First Medical University
state: Shandong
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: