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NCT05341128 Clinical Trial

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

Central Precocious Puberty Clinical Trial

Official title:
Patient Characteristics, Treatment Patterns, and Resource Usage in Children Diagnosed With Central Precocious Puberty (CPP) in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05341128
Other study ID # Leuprorelin-5007
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 31, 2025
Est. completion date February 28, 2026

Study information
Verified date February 2024
Source Takeda
Contact Takeda Contact
Phone +1-877-825-3327
Email medinfoUS@takeda.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Takeda

Outcome
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
See also
  Status Clinical Trial Phase
Completed NCT02920515 - Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty Phase 4
Completed NCT00779103 - Histrelin Subcutaneous Implant in Children With Central Precocious Puberty Phase 3
Completed NCT04736602 - Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty. Phase 3
Recruiting NCT05341115 - A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty Phase 4
Completed NCT02993926 - A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants
Recruiting NCT02811471 - Pharmacokinetic Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty Phase 3
Completed NCT03316482 - Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty Phase 4
Completed NCT01634321 - The Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty Phase 4
Terminated NCT02006680 - Markers of Pubertal Suppression During Therapy for Precocious Puberty
Completed NCT01278290 - Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls Phase 3
Completed NCT02427958 - A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants Phase 4
Completed NCT05029622 - A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty. Phase 3
Recruiting NCT06025409 - Evaluate the Efficacy and Safety of DWJ108J Phase 3
Recruiting NCT06129539 - A Study to Assess the Efficacy, Safety and Pharmacokinetics of Debio 4326 in Pediatric Participants Receiving Gonadotropin-Releasing Hormone Agonist Therapy for Central Precocious Puberty Phase 3
Completed NCT01467882 - Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty Phase 3
Recruiting NCT00438217 - Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children Phase 4

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