A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.
A Phase III, Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Chinese Paediatric Participants With Central Precocious Puberty.
2 other identifiers
interventional
66
1 country
14
Brief Summary
The purpose of the protocol is to assess the efficacy of the triptorelin 6 month PR (Prolonged Release) formulation in suppressing LH (Luteinising hormone) levels to prepubertal levels (defined as a peak LH ≤5 IU/L) after i.v. GnRH (Gonadotropin-releasing Hormone) stimulation at Month 6 (Day 169) in Chinese children with CPP (Central Precocious Puberty).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2021
14 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
August 9, 2021
CompletedStudy Start
First participant enrolled
August 10, 2021
CompletedFirst Posted
Study publicly available on registry
August 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2023
CompletedResults Posted
Study results publicly available
May 28, 2024
CompletedFebruary 19, 2025
February 1, 2025
1 year
August 9, 2021
November 30, 2023
February 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Luteinising Hormone (LH) Suppression
LH response was defined as a peak LH \<=5 international units per liter (IU/L) after intravenous (IV) gonadotropin-releasing hormone (GnRH) stimulation. The GnRH stimulation test was performed by using an IV injection of gonadorelin (synthetic GnRH) to stimulate gonadotrophin release and blood samples were collected after the gonadorelin injection for central assessment of serum LH levels. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100.
At Month 6
Secondary Outcomes (16)
Percentage of Participants With LH Response to GnRH Test
At Months 3 and 12
Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels
Baseline and at Months 3, 6, 9 and 12
Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test
Baseline and at Months 3, 6 and 12
Percentage of Participants With LH Response (Peak LH <=5 IU/L) From Month 6 to Month 12
Month 6 to Month 12
Percentage of Participants With Prepubertal Levels of Sex Steroids
At Months 3, 6, 9 and 12
- +11 more secondary outcomes
Study Arms (1)
Triptorelin formulation for Intramuscular injection (IM).
EXPERIMENTALInterventions
Triptorelin 6-month formulation for IM on day 1 and Month 6.
Eligibility Criteria
You may qualify if:
- Participant is less than 9 years old for girls and less than 10 years old for boys at initiation of triptorelin treatment or at the time of signing the informed consent.
- Participant must present evidence of CPP documented by:
- Onset of development of secondary sex characteristics (breast development in girls or testicular enlargement in boys according to the Tanner method: Stage II) before the age of 8 years in girls and 9 years in boys.
- Pubertal response of LH to GnRH stimulation test (stimulated peak LH ≥6 IU/L) in both sexes.
- Difference between bone age (BA) and CA \>1 year.
- Girls with Tanner staging ≥2 for breast development and who have enlarged uterine length and/or ovarian volume and at last 2 follicles with diameter \>4 mm in the ovary observed by pelvic type B ultrasound at the Screening visit; boys who have testicular volume ≥4 mL observed by testicular orchidometer at the Screening visit.
- Girls who have already had menophania/menarche must have a negative highly sensitive (urine) pregnancy test as required by local regulations within 24 hours before the first dose of study intervention and should not be at risk of pregnancy throughout the study period.
You may not qualify if:
- Gonadotropin-independent (peripheral) precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion.
- Non-progressing isolated premature thelarche.
- Presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. Participants with hamartomas not requiring surgery are eligible.
- Prior or current therapy with a GnRHa (Gonadotropin-releasing Hormone Agonist) , medroxyprogesterone acetate, growth hormone or insulin-like growth factor 1 (IGF 1).Use of anticoagulants (heparin and coumarin derivatives) within the 2 weeks prior to the Screening visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (14)
Beijing Children's Hospital, Capital Medical University
Beijing, 100045, China
No.1 Hospital of Jilin University (Bethune first hospital of Jilin University)
Changchun, 130021, China
Children's Hospital of Fudan University
Changhai, 201102, China
Hunan children's hospital
Changsha, 410007, China
Chengdu Women's & Children's Central Hospital
Chengdu, 610073, China
Shandong Provincial Hospital
Jinan, 250021, China
Linyi Maternal and Child Health Care Hospital
Linyi, 276016, China
Jiangxi Provincial Children's Hospital
Nanchang, 330006, China
Pingxiang Maternity and Child Care
Pingxiang, 337000, China
Children's Hospital of Soochow University
Suzhou, 215031, China
Wuhan Children's Hospital Tongji Medical College Huazhong University of Science & Technology
Wuhan, 430015, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, 430030, China
Wuxi children's Hospital
Wuxi, 214023, China
Zhengzhou Children's Hospital , Henan Children's Hospital
Zhengzhou, 450018, China
Related Publications (1)
Yu X, Cheng X, Wei H, Xu X, Gong C, Li G, Yao H, Zhou L, Zhong Y, Yang Y, Luo F, Zhang Y, Huang F, Shi X, Cabri P, Luo X. A Phase 3, Open-Label, Single-Arm Trial of the Efficacy and Safety of Triptorelin 6-Month Formulation in Chinese Children with Central Precocious Puberty. Adv Ther. 2024 Dec;41(12):4537-4556. doi: 10.1007/s12325-024-02991-x. Epub 2024 Oct 16.
PMID: 39412628DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2021
First Posted
August 31, 2021
Study Start
August 10, 2021
Primary Completion
August 21, 2022
Study Completion
February 13, 2023
Last Updated
February 19, 2025
Results First Posted
May 28, 2024
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.