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    Summary
    EudraCT Number:2022-002963-31
    Sponsor's Protocol Code Number:D-CN-52014-243
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2023-01-13
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2022-002963-31
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study seeks to check if a drug named as triptorelin 3-month formulation is safe and works to treat a condition called central precocious puberty in Chinese children. Precocious puberty is a condition that causes early sexual development in girls and boys. This trial was conducted at multiple-centers and was open-label which means subjects knew what medicine they were getting.
    A.4.1Sponsor's protocol code numberD-CN-52014-243
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04736602
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIpsen Pharma
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIpsen Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpsen Pharma
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address65, Quai Georges Gorse
    B.5.3.2Town/ cityBoulogne Billancourt
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 58 33 50 50
    B.5.6E-mailclinical.trials@ipsen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma
    D.2.1.2Country which granted the Marketing AuthorisationChina
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nametriptorelin pamoate
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIPTORELIN PAMOATE
    D.3.9.1CAS number 124508-66-3
    D.3.9.4EV Substance CodeSUB16393MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Central Precocious Puberty
    E.1.1.1Medical condition in easily understood language
    Precocious puberty is a condition that causes early sexual development in girls and boys.
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are as follows:
    • To assess the efficacy in suppressed LH response to GnRH test at Month 6
    • To assess follicle-stimulating hormone (FSH) response to GnRH test at Month 3 and Month 6
    • To assess LH and FSH levels at Month 3 and Month 6
    • To assess sex hormone serum concentrations (oestradiol for girls and testosterone for boys) at Month 3 and Month 6
    • To assess sexual maturation (pubertal stage as per Tanner method) at Month 6
    • To assess auxological parameters including height, growth velocity, weight and body mass index (BMI) at Month 3 and Month 6
    • To assess bone age (BA), the difference between BA and chronological age (CA) at Month 6
    • To assess gonadal development as determined by uterine length in girls and testicular volume in boys at Month 6
    • To assess the safety profile.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    1) Proportion of children with Luteinising Hormone (LH) suppression defined as stimulated peak LH ≤3 IU/L after Gonadotropin-releasing Hormone (GnRH) stimulation
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) 3 months after first injection of study drug (for main study)
    E.5.2Secondary end point(s)
    1) Basal Luteinising Hormone (LH) and Follicle Stimulating Hormone (FSH) serum levels
    2) Peak LH after GnRH stimulation test
    3) Peak FSH levels after GnRH stimulation test
    4) Oestradiol or testocterone serum concentration
    5) Pubertal stage (Tanner Method)
    6) Auxological parameters (height, growth velocity, weight, BMI)
    7) Bone Age
    8) Gonad development
    9) Proportion of children with LH suppression defined as stimulated peak LH ≤3 IU/L after GnRH stimulation
    10) Proportion of children with pre-pubertal levels of sex steroids
    11) Proportion of children with stabilised pubertal stage compared to baseline stage using the Tanner method
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) and 4): Baseline, Month 3 and Month 6 (End of Study of main study), for the extension phase study: month 9 and month 12
    2) and 3): Baseline, Month 3 and Month 6 (End of Study of main study), for the extension phase study: month 12
    5)& 7): Baseline and Month 6 (End of Study of main study) and month 12 for the extension phase study
    6) Baseline, Month 3 and Month 6 (End of Study of main study), for the extension phase study: month 9 and 12
    8) Baseline and Month 6 (End of Study of main study) and month 12 for the extension phase study
    9) Month 6 of main study and at month 12 for the extension phase study
    10) Month 3 and Month 6 for the main study and for the extension phase study: month 9 and month 12
    11) Month 6 for the main study and month 12 for the extension phase study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    China
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Subject Last Visit (LSLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 32
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 32
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 32
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participants will not receive any additional study intervention or care following the end of the extension phase of the study.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: China
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