Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.

Central Precocious Puberty Clinical Trial

Official title:

An Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of Triptorelin 3-month Formulation in Chinese Children With Central Precocious Puberty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04736602
• Other study ID #: D-CN-52014-243
• Status: Completed
• Phase: Phase 3
• Start date: March 27, 2021
• Est. completion date: September 3, 2022

Study information

• Verified date: October 2022
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to observe whether the Triptorelin pamoate 15mg (3-month formulation) effectiveness in Chinese population of CPP children has the same or similar trend with that in overseas CPP population. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection of triptorelin.

Description:

For patients enter extension phase, two additional Triptorelin injections will be given at month 6 and month 9 visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 3, 2022
• Est. primary completion date: February 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

Inclusion Criteria:

• Onset of development of secondary sex characteristics before 8 and 9 years in girls and boys, respectively breast development in girls or testicular enlargement in boys according to the Tanner method: Stage II
• Pubertal response of LH to GnRH stimulation test (stimulated peak LH =5 IU/L)
• Difference between bone age (BA) (according to Greulich and Pyle method) and chronological age (CA) >1 year
• Girls with Tanner staging =2 for breast development and enlarged uterine length and several follicles with diameter >4 mm in the ovary at Screening visit; boys who have testicular volume =4 mL at Screening visit
• Age < 9 years old for girls and < 10 years old for boys at initiation of triptorelin treatment
• Weight at least 20 kg
• Subjects will qualify for the extension phase if they sign the corresponding specific consent form, are still benefiting from treatment at the end the primary study and have not experienced any unacceptable safety issues.

Exclusion Criteria:

• Gonadotropin-independent (peripheral) precocious puberty: extra pituitary 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
• Evidence of renal (creatinine >1.5 x upper limit of normal (ULN)) or hepatic impairment (bilirubin >1.5 x ULN or alanine aminotransferase (ALT)/aspartate transaminase (AST) >3 x ULN)
• Any other condition or chronic illness or treatment possibly interfering with growth or other study endpoints (e.g. chronic steroid use except topical steroids, renal failure, diabetes, moderate to severe scoliosis)
• Prior or current therapy with a GnRH agonist (GnRHa), medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1)
• Diagnosis of short stature, i.e. >2.25 standard deviation (SD) below the mean height for age
• Major medical or psychiatric illness that could interfere with study visits
• Known hypersensitivity to any of the test materials or related compounds
• Use of anticoagulants (heparin and coumarin derivatives) within the 2 weeks prior to the Screening visit.

Related Conditions & MeSH terms

• Central Precocious Puberty
• Puberty, Precocious

Intervention

Drug:
• Triptorelin pamoate 15mg
Intramuscular injection (IM)

Locations

Country	Name	City	State
China	Chengdu Women's and Children's Central Hospital	Chengdu
China	Jiangxi Provincial Children's Hospital	Nanchang
China	Children's Hospital of Nanjing	Nanjing
China	Tangshan Maternal & Child Health Hospital	Tangshan
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology	Wuhan
China	Wuxi Children's Hospital	Wuxi
China	Henan Children's Hospital, Zhengzhou Children's Hospital	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children with Luteinising Hormone (LH) suppression defined as stimulated peak LH =3 IU/L after Gonadotropin-releasing Hormone (GnRH) stimulation		3 months after first injection of study drug (for main study)
Secondary	Basal Luteinising Hormone (LH) and Follicle Stimulating Hormone (FSH) serum levels		Baseline, Month 3 and Month 6 (End of Study of main study), for the extension phase study: month 9 and month 12
Secondary	Peak LH after GnRH stimulation test		Baseline, Month 3 and Month 6 (End of Study of main study), for the extension phase study: month 12]
Secondary	Peak FSH levels after GnRH stimulation test		Baseline, Month 3 and Month 6 (End of Study of main study), for the extension phase study: month 12.
Secondary	Oestradiol or testocterone serum concentration		Baseline, Month 3 and Month 6 (End of Study of main study), for the extension phase study month 9 and month 12.
Secondary	Pubertal stage (Tanner Method)		Baseline and Month 6 (End of Study of main study) and month 12 for the extension phase study.
Secondary	Auxological parameters (height, growth velocity, weight, BMI)		Baseline, Month 3 and Month 6 (End of Study of main study), for the extension phase study: month 9 and 12.
Secondary	Bone Age		Baseline and Month 6 (End of Study of main study) and month 12 for the extension phase study.
Secondary	Gonad development (Uterine length or testis volume)		Baseline and Month 6 (End of Study of main study) and month 12 for the extension phase study.
Secondary	Proportion of children with LH suppression defined as stimulated peak LH =3 IU/L after GnRH stimulation		Month 6 of main study and at month 12 for the extension phase study.
Secondary	Proportion of children with pre-pubertal levels of sex steroids (defined as oestradiol =20 pg/mL in girls and testosterone =0.3 ng/mL in boys)		Month 3 and Month 6 for the main study and for the extension phase study: month 9 and month 12.
Secondary	Proportion of children with stabilised pubertal stage compared to baseline stage using the Tanner method		Month 6 for the main study and month 12 for the extension phase study.