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A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05029622
Recruitment Status : Active, not recruiting
First Posted : August 31, 2021
Last Update Posted : November 21, 2022
Sponsor:
Information provided by (Responsible Party):
Ipsen

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).

Condition or disease Intervention/treatment Phase
Central Precocious Puberty Drug: Triptorelin Pamoate Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : August 10, 2021
Actual Primary Completion Date : August 21, 2022
Estimated Study Completion Date : March 4, 2023


Arm Intervention/treatment
Experimental: Triptorelin formulation for Intramuscular injection (IM). Drug: Triptorelin Pamoate
Triptorelin 6-month formulation for IM on day 1 and Month 6.




Primary Outcome Measures :
  1. Proportion of children with LH (Luteinising Hormone) suppression defined as stimulated peak LH ≤5 IU/L after GnRH (Gonadotropin-releasing Hormone) stimulation. [ Time Frame: At month 6. ]

Secondary Outcome Measures :
  1. Proportion of children with LH response to GnRH test. [ Time Frame: At months 3 and month 12. ]
  2. Change from basal serum LH levels. [ Time Frame: At months 3, 6, 9 and 12. ]
  3. Change from baseline in basal FSH (Follicle-stimulating Hormone) levels [ Time Frame: At months 3,6, 9 and 12 ]
  4. Change from baseline in peak serum LH levels after the GnRH stimulation test [ Time Frame: At months 3, 6 and 12. ]
  5. Change from baseline in peak serum FSH levels after the GnRH stimulation test [ Time Frame: At months 3, 6 and 12. ]
  6. Proportion of children with pre-pubertal levels of sex steroids. [ Time Frame: Months 3, 6, 9 and 12. ]
    Defined as oestradiol ≤20 pg/mL in girls or testosterone ≤30 ng/dL in boys

  7. Change from baseline in height-for-age Z-score [ Time Frame: At months 6 and 12. ]
  8. Change from baseline in height-for-age percentile [ Time Frame: At months 6 and 12. ]
  9. Change from baseline in growth velocity [ Time Frame: At months 6 and 12. ]
  10. Proportion of children in whom the BA/CA (Bone Age/Chronological Age) ratio did not rise (X ray). [ Time Frame: At months 6 and 12. ]
  11. Change in the ratio BA/CA [ Time Frame: At months 6 and 12. ]
  12. Proportion of children who achieve stabilisation of sexual maturation compared to baseline stage using Tanner method. [ Time Frame: At months 6 and 12. ]
  13. Proportion of girls with regression of uterine length [ Time Frame: At months 6 and 12. ]
    Clinical assessment with transabdominal ultrasound

  14. Proportion of boys with absence of progression of testis volumes [ Time Frame: At month 6 and 12. ]
    Clinical assessment with orchidometer.

  15. Change in BMI (Body Mass Index). [ Time Frame: At months 6 and 12. ]
  16. Change in weight. [ Time Frame: At months 6 and 12. ]
  17. Incidence of TEAEs (treatment-emergent adverse events), including local tolerability at the injection site. [ Time Frame: 1 year, including immediately and 2 hours after triptorelin injection. ]
  18. Change in clinical safety laboratory: blood biochemistry parameters. (Creatinine, Non fasting Glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase, Total and direct bilirubin, Calcium, Phosphorous), [ Time Frame: At month 3, 6, 9 and 12. ]
    Any abnormal laboratory test results or other safety assessments, including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the investigator

  19. Change in clinical safety laboratory haematology parameters (Complete blood count). [ Time Frame: At month 3, 6, 9 and 12. ]
  20. Change in clinical safety laboratory urinalysis parameters (Specific gravity, pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick). [ Time Frame: At month 3, 6, 9 and 12. ]
  21. Change in physical examination. [ Time Frame: At day 1, months 3, 6, 9 and 12. ]
    A complete physical examination will include, assessments of the cardiovascular, respiratory, gastrointestinal and neurological systems. Height and weight.

  22. Change in vital signs: Change in heart rate. [ Time Frame: At day 1, months 3, 6, 9 and 12. ]
  23. Change in vital signs: Change in blood pressure. [ Time Frame: At day 1, months 3, 6, 9 and 12. ]
  24. Sparse plasma triptorelin concentrations [ Time Frame: At day 1, months 3, 6 and 12. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05029622


Locations
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China
Beijing Children's Hospital, Capital Medical University
Beijing, China, 100045
No.1 Hospital of Jilin University (Bethune first hospital of Jilin University)
Changchun, China, 130021
Children's Hospital of Fudan University
Changhai, China, 201102
Hunan children's hospital
Changsha, China, 410007
Chengdu Women's & Children's Central Hospital
Chengdu, China, 610073
Shandong Provincial Hospital
Jinan, China, 250021
Linyi Maternal and Child Health Care Hospital
Linyi, China, 276016
Jiangxi Provincial Children's Hospital
Nanchang, China, 330006
Pingxiang Maternity and Child Care
Pingxiang, China, 337000
Children's Hospital of Soochow University
Suzhou, China, 215031
Wuhan Children's Hospital Tongji Medical College Huazhong University of Science & Technology
Wuhan, China, 430015
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, China, 430030
Wuxi children's Hospital
Wuxi, China, 214023
Zhengzhou Children's Hospital , Henan Children's Hospital
Zhengzhou, China, 450018
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT05029622    
Other Study ID Numbers: D-CN-52014-244
First Posted: August 31, 2021    Key Record Dates
Last Update Posted: November 21, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

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/).
URL: https://vivli.org/members/ourmembers/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Antineoplastic Agents, Hormonal
Antineoplastic Agents