Debio 4326 for Precocious Puberty
(LIBELULA Trial)
Recruiting in Palo Alto (17 mi)
+49 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Debiopharm International SA
Must be taking: GnRHa therapy
Must not be taking: Medroxyprogesterone, Growth hormone, IGF-1
Disqualifiers: Peripheral precocious puberty, Intracranial tumor, Diabetes, Seizures, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing an injectable medication called Debio 4326. It is aimed at children who start puberty too early and are already receiving another treatment. The goal is to lower a hormone that triggers puberty, helping to delay its onset.
Will I have to stop taking my current medications?
The trial requires participants to be on GnRHa therapy, but you cannot be on other treatments that affect hormone levels or growth. If you're taking medications like medroxyprogesterone acetate, growth hormone, or IGF-1, you would need to stop those before joining the trial.
What data supports the effectiveness of the drug Debio 4326 for treating precocious puberty?
Research shows that triptorelin, a component of Debio 4326, is effective in treating central precocious puberty (CPP) by helping manage early puberty and improve final adult height. Studies have demonstrated its efficacy in various formulations, including 3-month and 6-month versions, for managing CPP.
12345Is Debio 4326 (Triptorelin) safe for treating precocious puberty?
Research on Triptorelin, including various formulations, shows it is generally safe for treating central precocious puberty in children. Studies have reported effective suppression of puberty-related hormones with manageable side effects.
13678How is the drug Debio 4326 different from other treatments for precocious puberty?
Debio 4326, a 12-month formulation of triptorelin, is unique because it reduces the frequency of injections needed for treating precocious puberty, offering greater convenience compared to the more common 1-, 3-, and 6-month formulations.
12369Eligibility Criteria
This trial is for children diagnosed with central precocious puberty (CPP) who are already on hormone therapy. It's open to kids aged 5-8, and possibly older or younger after an interim review. They should have started puberty early—before age 8 in girls and 9 in boys—and begun treatment within 18 months of these first signs.Inclusion Criteria
I developed early signs of puberty before age 8 (if girl) or 9 (if boy).
I am between 5 and 8 years old.
I will be on hormone therapy for at least 1 year starting now.
+5 more
Exclusion Criteria
My early breast development has not worsened before starting hormone therapy.
I have a brain tumor that might need surgery or radiation.
I am currently on treatment that could affect my hormone levels.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Part A
Participants receive the first injection of Debio 4326
52 weeks
Multiple visits for monitoring hormone levels and pharmacokinetics
Treatment Part B
Participants receive the second injection of Debio 4326
52 weeks
Multiple visits for monitoring hormone levels and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
Post Treatment Visit (PTV) for final assessments
Participant Groups
The study tests Debio 4326's ability to maintain low levels of a puberty-related hormone over a year in kids treated for CPP. The goal is to see if this drug can effectively keep the signs of early puberty under control when used alongside standard hormone therapy.
1Treatment groups
Experimental Treatment
Group I: Debio 4326Experimental Treatment1 Intervention
Participants will receive the first injection of Debio 4326, on Day 1 in Part A followed by a second injection 52 weeks later in Part B of the study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California San Francisco-Benioff Children's HospitalSan Francisco, CA
Texas Children's HospitalHouston, TX
CAMCCharleston, WV
University of Texas Southwestern Medical CenterDallas, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Debiopharm International SALead Sponsor
References
Effect of GnRHa 3.75 mg subcutaneously every 6 weeks on adult height in girls with idiopathic central precocious puberty. [2022]To evaluate the long-term efficacy of triptorelin 3.75 mg subcutaneously every 6 weeks on the final height in girls with idiopathic central precocious puberty (ICPP).
Meta-Analysis of Paediatric Patients with Central Precocious Puberty Treated with Intramuscular Triptorelin 11.25 mg 3-Month Prolonged-Release Formulation . [2019]A meta-analysis was undertaken to assess the effect of triptorelin 11.25 mg 3-month prolonged-release formulation in central precocious puberty (CPP).
A 6-Month Trial of the Efficacy and Safety of Triptorelin Pamoate (11.25 mg) Every 3 Months in Children with Precocious Puberty: A Retrospective Comparison with Triptorelin Acetate. [2018]To evaluate the efficacy and safety of a triptorelin pamoate (11.25 mg) 3-month formulation in the management of central precocious puberty (CPP) (TP Study) and to retrospectively compare it with a triptorelin acetate (11.25 mg) 3-month formulation (TA Study).
Final height in central precocious puberty after long term treatment with a slow release GnRH agonist. [2022]To study the resumption of puberty and the final height achieved in children with central precocious puberty (CPP) treated with the GnRH agonist triptorelin.
Efficacy and safety of triptorelin 6-month formulation in patients with central precocious puberty. [2019]Triptorelin is an established treatment for central precocious puberty (CPP) as 1- and 3-month formulations. The current triptorelin 22.5 mg 6-month formulation is approved for prostate cancer therapy. This is the first study in patients with CPP.
Impact of 6-month triptorelin formulation on predicted adult height and basal gonadotropin levels in patients with central precocious puberty. [2023]Triptorelin, a long-acting gonadotropin-releasing hormone (GnRH) agonist, is available in 1-, 3-, and 6-month formulations to treat central precocious puberty (CPP). The triptorelin pamoate 22.5-mg 6-month formulation recently approved for CPP offers greater convenience to children by reducing the injection frequency. However, worldwide research on using the 6-month formulation to treat CPP is scarce. This study aimed to determine the impact of the 6-month formulation on predicted adult height (PAH), changes in gonadotropin levels, and related variables.
Efficacy of the subcutaneous reformulated triptorelin depot in children with central precocious puberty. [2019]The efficacy, safety and acceptance of newly formulated triptorelin s.c. (Decapeptyl Depot, DDsc) was compared to triptorelin i.m. (DDim) in seven children with central precocious puberty (CPP) in a prospective study. Both formulations were given for 6 months consecutively. During both treatment periods suppression of basal and gonadotropin-releasing hormone (GnRH)-stimulated levels of luteinizing hormone and follicle-stimulating hormone, suppression of sex steroids, arrest of the maturation of gonads and uterus, and slowing of bone maturation were achieved. The height standard deviation score for bone age increased significantly during DDsc treatment (-1.33+/-0.90 to 1.07+/-0.92, p
Efficacy and Safety of Triptorelin 3-Month Formulation in Chinese Children with Central Precocious Puberty: A Phase 3, Open-Label, Single-Arm Study. [2023]Triptorelin is available as 1- and 3-month prolonged-release (PR) formulations; at the time of the study, only the former was approved for central precocious puberty (CPP) in China. This study assessed the efficacy and safety of the triptorelin 3-month PR formulation in Chinese children with CPP.
Efficacy of Triptorelin 3-Month Depot Compared to 1-Month Depot for the Treatment of Korean Girls with Central Precocious Puberty in Single Tertiary Center. [2021]Triptorelin depot is largely used to treat central precocious puberty (CPP) in children, and a 3-month depot has been introduced. However, data about the 3-month gonadotropin-releasing hormone use for treatment of CPP in Korean girls are not available. This study was conducted to compare the efficacy of a triptorelin 11.25 mg 3-month depot with that of a 3.75 mg 1-month depot in suppressing pubertal development for the treatment of CPP.