A Study of Medical Records From Children With Central Precocious Puberty (CPP) in China
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
• 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.
- Not received GnRHa as the treatment for CPP.
- No available data for analysis.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With CPP Treatment Up to approximately 10 years
- Secondary Outcome Measures
Name Time Method Percentage of Participants With CPP Treatment at Baseline At Baseline Percentage of Participants With Luteinizing hormone (LH) Suppression Baseline up to approximately 10 years Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Up to approximately 10 years
Trial Locations
- Locations (5)
The Second Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Hainan Women and Children's Medical Center
🇨🇳Haikou, Hainan, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
🇨🇳Wuhan, Hubei, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
🇨🇳Jinan, Shandong, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China