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

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ClinicalTrials.gov Identifier: NCT04736602
Recruitment Status : Not yet recruiting
First Posted : February 3, 2021
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief 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.

Condition or disease Intervention/treatment Phase
Central Precocious Puberty Drug: Triptorelin pamoate 15mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2, 2021
Estimated Primary Completion Date : November 26, 2021
Estimated Study Completion Date : February 26, 2022


Arm Intervention/treatment
Experimental: Triptorelin Pamoate 15mg for injection
Triptorelin will be injected at day 1 and month 3
Drug: Triptorelin pamoate 15mg
Intramuscular injection (IM)




Primary Outcome Measures :
  1. Proportion of children with Luteinising Hormone (LH) suppression defined as stimulated peak LH ≤3 IU/L after Gonadotropin-releasing Hormone (GnRH) stimulation [ Time Frame: 3 months after first injection of study drug ]

Secondary Outcome Measures :
  1. Basal Proportion of children with Luteinising Hormone (LH) and Follicle Stimulating Hormone (FSH) serum levels [ Time Frame: Baseline, Month 3 and Month 6 (End of Study) ]
  2. Peak LH after GnRH stimulation test [ Time Frame: Baseline, Month 3 and Month 6 (End of Study) ]
  3. Peak FSH levels after GnRH stimulation test [ Time Frame: Baseline, Month 3 and Month 6 (End of Study) ]
  4. Oestradiol serum concentration [ Time Frame: Baseline, Month 3 and Month 6 (End of Study) ]
  5. Testosterone serum concentration [ Time Frame: Baseline, Month 3 and Month 6 (End of Study) ]
  6. Pubertal stage (Tanner Method) [ Time Frame: Baseline and Month 6 (End of Study) ]
  7. Auxological parameters (height, growth velocity, weight, BMI) [ Time Frame: Baseline, Month 3 and Month 6 (End of Study) ]
  8. Bone Age [ Time Frame: Baseline and Month 6 (End of Study) ]
  9. Gonad development (Uterine length or testis volume) [ Time Frame: Baseline and Month 6 (End of Study) ]
  10. Proportion of children with LH suppression defined as stimulated peak LH ≤3 IU/L after GnRH stimulation [ Time Frame: Month 6 ]
  11. 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) [ Time Frame: Month 3 and Month 6 ]
  12. Proportion of children with stabilised pubertal stage compared to baseline stage using the Tanner method [ Time Frame: Month 6 ]


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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:

  • 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

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.

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): NCT04736602


Contacts
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Contact: Ipsen Recruitment Enquiries see email clinical.trials@ipsen.com

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: NCT04736602    
Other Study ID Numbers: D-CN-52014-243
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.
Time Frame: Data are available beginning 6 months and ending 5 years after the publication of the findings in a journal; after this time, only raw data may be available.
Access Criteria: Proposals should be submitted to DataSharing@ipsen.com and will be assessed by a scientific review board.

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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
Antineoplastic Agents, Hormonal
Antineoplastic Agents