A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants
An Open Label, Multicenter Study to Assess the Safety and Efficacy of Leuprorelin in the Treatment of Central Precocious Puberty
3 other identifiers
interventional
307
1 country
9
Brief Summary
The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the treatment of Central Precocious Puberty (CPP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2015
Typical duration for phase_4
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2015
CompletedFirst Posted
Study publicly available on registry
April 28, 2015
CompletedStudy Start
First participant enrolled
August 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2018
CompletedResults Posted
Study results publicly available
July 24, 2019
CompletedMarch 16, 2022
March 1, 2022
3.3 years
April 23, 2015
May 21, 2019
March 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Day 1 up to Week 100
Secondary Outcomes (1)
Percentage of Participants With Regression or no Progression in Tanner Staging at Week 96
Week 96
Study Arms (1)
Leuprorelin
EXPERIMENTALParticipants with body weight greater than or equal to (\>=) 20 kilogram (kg) will receive the recommended dose of leuprorelin 3.75 milligram (mg), injection, subcutaneously, once every 4 weeks for 96 weeks. Participants with body weight less than (\<) 20 kg will receive leuprorelin 1.88 mg, injection, subcutaneously, once every 4 weeks for 96 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- In the opinion of the investigator, the participant and/or parent(s) or legal guardian are capable of understanding and complying with protocol requirements.
- The participant or the participant's parent(s) or legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Has onset of appearance of secondary sexual characteristic earlier than age 8.0 years in girls or earlier than 9.0 years in boys and the symptom is persistent, and has confirmed diagnosis of CPP.
- Has basal luteinizing hormone (LH) level greater than (\>) 5.0 international units per liter (IU/L) or peak LH \>3.3 IU/L with LH/follicle-stimulating factor (FSH) \>0.6 in stimulation test.
- Has evidence of gonadal development evaluated by ultrasonography: ovarian volume \>=1 milliliter (mL) with multiple follicles \>=4 millimeter (mm) in any ovary or uterine enlargement in females or testicular volume \>=4 mL in males.
- Has advanced bone age (BA) \>=1 year and BA is less than or equal to (\<=) 11.5 years in females or \<=12.5 years in males OR predicted adult height \<150 centimeter (cm) in females or \<160 cm in males OR standard deviation score (SDS) \<-2 standard deviations (SD) OR rapid growth defined as growth of BA /growth of chronologic age \>1. BA is determined by Greulich and Pyle standards or Tanner-Whitehouse 3 (TW3) standards at screening.
- Has anticipated treatment duration of at least 2 year in investigator's judgment.
- A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 90 days after last dose.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
- The female participant who, at the discretion of the investigator, is deemed to be of child bearing potential must provide negative urine pregnancy text at Day -1 or Day 1 prior to drug administration.
You may not qualify if:
- Has received any investigational compound within 30 days prior to Screening.
- Has received gonadotropin-releasing hormone analog (GnRHa) treatment in a previous clinical study or as a therapeutic agent.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example \[eg\], spouse, parent, child, sibling) or may consent under duress.
- Has any findings in his/her medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of underlying disease that might interfere with the conduct of the trial.
- Has any concomitant medical condition that, in the opinion of the investigator, may expose a participant to an unacceptable level of safety risk or that affects participant compliance.
- Has any screening abnormal laboratory value that suggests a clinically significant underlying disease or condition that may prevent the participant from entering the study; or the participant has: creatinine \>=1.5 milligram per deciliter (mg/dL), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2 times the upper limit of normal (ULN), or total bilirubin \>2.0 mg/dL, with AST/ALT elevated above the limits of normal values.
- Has a history or clinical manifestations of significant adrenal or thyroid diseases or intracranial tumor OR has a history of malignant disease.
- Has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound.
- Has a diagnosis of peripheral precocious puberty.
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening Visit.
- Participant or parent(s), at the discretion of the investigator, is unlikely to comply with the protocol or is unsuitable for any of other reason.
- If female, the participant is of childbearing potential (eg, not sterilized).
- If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
- If male, the participant intends to donate sperm during the course of this study or for 90 days thereafter.
- Has participated in another clinical study and/or has received any investigational compound within 30 days prior to Screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (9)
Unknown Facility
Beijing, Beijing Municipality, China
Unknown Facility
Wuhan, Hubei, China
Unknown Facility
Changsha, Hunan, China
Unknown Facility
Nanjing, Jiangsu, China
Unknown Facility
Wuxi, Jiangsu, China
Unknown Facility
Nanchang, Jiangxi, China
Unknown Facility
Changchun, Jilin, China
Unknown Facility
Shanghai, Shanghai Municipality, China
Unknown Facility
Hangzhou, Zhejiang, China
Related Publications (1)
Luo X, Hou L, Zhong Y, You C, Yang Y, Wu X, Li P, Zhou S, Qiu W, Zhang H, Liu Y, Qian Y, Luo F, Cheng R, Hu Y, Gong H, Wang Q, Xu Z, Du H, Lu F, Fu J, Chen X, Wang W, Guo Z. An open label, multicenter clinical trial that investigated the efficacy and safety of leuprorelin treatment of central precocious puberty in Chinese children. Medicine (Baltimore). 2021 Dec 23;100(51):e28158. doi: 10.1097/MD.0000000000028158.
PMID: 34941067DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2015
First Posted
April 28, 2015
Study Start
August 7, 2015
Primary Completion
November 23, 2018
Study Completion
November 23, 2018
Last Updated
March 16, 2022
Results First Posted
July 24, 2019
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.