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

NCT04736602 | Completed Phase 3 Results

• 1 other identifier: D-CN-52014-243
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this research was to confirm the effectiveness and safety of the study drug, Triptorelin pamoate 15mg 3-month formulation, in a Chinese population of Central Precocious Puberty (CPP) children.

Conditions

Central Precocious Puberty

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Luteinising Hormone (LH) Suppression After Gonadotropin-Releasing Hormone (GnRH) Stimulation

  The LH suppression was defined as stimulated peak LH ≤3 International Units/Liter (IU/L). The GnRH stimulation test was performed by using an intravenous (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.

  At Month 3

Secondary Outcomes (16)

• Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels

  Baseline (Day 1) and at Months 3, 6, 9 and 12

• Percentage of Participants With LH Suppression After GnRH Stimulation

  At Months 6 and 12

• Change From Baseline in Peak LH and FSH Level After GnRH Stimulation

  Baseline (Day 1) and at Months 3, 6 and 12

• Percentage of Participants With Prepubertal Levels of Sex Steroids

  At Months 3, 6, 9 and 12

• Change From Baseline in Estradiol Levels

  Baseline (Day 1) and at Months 3, 6 ,9 and 12

Study Arms (1)

Triptorelin Pamoate 15mg for injection

EXPERIMENTAL

Triptorelin was injected at day 1 and month 3. If participants were willing to enter the extension phase, two additional Triptorelin injections were given at month 6 and month 9.

Drug: Triptorelin pamoate 15mg

Interventions

Triptorelin pamoate 15mg DRUG

Intramuscular injection (IM)

Triptorelin Pamoate 15mg for injection

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (7)

Chengdu Women's and Children's Central Hospital

Chengdu, 610073, China

Location

Jiangxi Provincial Children's Hospital

Nanchang, 330006, China

Location

Children's Hospital of Nanjing

Nanjing, 210008, China

Location

Tangshan Maternal & Child Health Hospital

Tangshan, 063000, China

Location

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, 430030, China

Location

Wuxi Children's Hospital

Wuxi, 214023, China

Location

Henan Children's Hospital, Zhengzhou Children's Hospital

Zhengzhou, 450018, China

Location

MeSH Terms

Conditions

Puberty, Precocious

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Medical Director
• Organization: Ipsen Pharma

clinical.trials@ipsen.com

see email

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

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: January 29, 2021
• First Posted: February 3, 2021
• Study Start: March 27, 2021
• Primary Completion: February 9, 2022
• Study Completion: September 3, 2022
• Last Updated: August 1, 2024
• Results First Posted: August 1, 2024

Record last verified: 2024-02

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/).

Locations

CN (7)