Central Precocious Puberty Clinical Trial
Official title:
Patient Characteristics, Treatment Patterns, and Resource Usage in Children Diagnosed With Central Precocious Puberty (CPP) in China
Verified date | February 2024 |
Source | Takeda |
Contact | Takeda Contact |
Phone | +1-877-825-3327 |
medinfoUS[@]takeda.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | February 28, 2026 |
Est. primary completion date | December 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Takeda |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From 07 August 2015 to 31 December 2022 | ||
Secondary | Percentage of Participants With Change From Baseline in Decreased Ratio of Bone Age Over Chronological Age | Baseline up to 31 December 2022 | ||
Secondary | Percentage of Participants With Change From Baseline in Decreased Ratio of Predicted Adult Height | Baseline up to 31 December 2022 |
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