Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

52 ugers undersøgelse af sikkerhed, PK og effektivitet af XYOSTED® til testosteronerstatning hos mandlige unge med hypogonadisme

5. november 2026 opdateret af: Halozyme Therapeutics

Open-label, multiple-dosis, 52-ugers undersøgelse for at evaluere sikkerheden, PK og effektiviteten af ​​XYOSTED® til testosteronerstatning hos mandlige unge med mangel eller fravær af endogent testosteron på grund af primær eller sekundær hypogonadisme

This is a 52-week open label single arm study + 24-Month long-term safety extension to investigate the effects of XYOSTED, as testosterone replacement therapy, on adolescent males with either primary or secondary hypogonadism.

The study aims to determine the effectiveness of XYOSTED measured by continuation or induction of puberty in addition to XYOSTED dosage, safety and testosterone levels.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a Phase 3/4, open-label, multicenter study in approximately 100 males 12 to < 18 years of age with primary or secondary hypogonadism (congenital or acquired). Each participant will be screened for eligibility within 28 days before receiving his first dose of study drug on Day 1. During the Screening period, each participant will have a full clinical examination with pubertal staging, including 2 separate serum total testosterone (TT) measurements obtained in the early morning, where the average (Cavg) will be considered baseline value. Each participant will be categorized as having primary or secondary hypogonadism prior to dosing on Day 1.

Participants meeting all eligibility criteria will be assigned to a starting dose of XYOSTED based on their weight and Targeted Tanner Stage on Day 1. The Targeted Tanner Stage will be determined during Screening by an experienced pediatric endocrinologist.

Participants will have dose adjustments during the study to achieve their Targeted Tanner Stage. Dose adjustments will be based on reviewing the TT concentration between doses (Cmid) by measuring serum TT 14 days after the administration of XYOSTED for participants receiving the Q4W schedule, 7 days after the administration of XYOSTED for participants who are on the Q2W schedule, and 4 days after administration of XYOSTED for participants on the Q1W schedule. Participants will be evaluated for further dose adjustments approximately every 3 months to achieve the desired targeted TT level.

Following the 52-week primary study, participants may join a 24-month long-term safety extension study to continue the evaluation of XYOSTED in this population. Participants will return to the clinic at 6-month intervals for evaluation for clinical evaluations, and laboratory and pharmacokinetic assessments.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90027
        • Rekruttering
        • Children's Hospital Los Angeles
      • Los Angeles, California, Forenede Stater, 90048
        • Rekruttering
        • Cedars-Sinai Medical Center
      • San Diego, California, Forenede Stater, 92123
        • Rekruttering
        • Rady Children's Hospital - San Diego
      • San Francisco, California, Forenede Stater, 94143
        • Rekruttering
        • University of California San Francisco
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Rekruttering
        • Children's Hospital Colorado
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32207
        • Rekruttering
        • Nemours Children's Specialty Care - Jacksonville
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Rekruttering
        • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Rekruttering
        • Boston Children's Hospital
      • Worcester, Massachusetts, Forenede Stater, 01655
        • Rekruttering
        • University of Massachusetts Memorial Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55454
        • Rekruttering
        • M Health Fairview U Minnesota
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Rekruttering
        • Washington University School of Medicine in St. Louis
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89113
        • Rekruttering
        • The DOCS
    • New York
      • The Bronx, New York, Forenede Stater, 10467
        • Rekruttering
        • Children's Hospital at Montefiore
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Rekruttering
        • OUHSC Pediatric Diabetes & Endocrinology
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Rekruttering
        • Children's Hospital of Philadelphia
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29203
        • Rekruttering
        • Prisma Health Children's Hospital - Midlands
    • Texas
      • El Paso, Texas, Forenede Stater, 79902
        • Rekruttering
        • MedResearch
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • Texas Children's Hospital
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Rekruttering
        • Primary Children's Hospital
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • Rekruttering
        • University of Virginia School of Medicine
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Rekruttering
        • Seattle Children's Hospital
      • Tacoma, Washington, Forenede Stater, 98405
        • Rekruttering
        • MultiCare Institute for Research & Innovation

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  1. Diagnosed with a deficiency or absence of endogenous testosterone due to primary or secondary hypogonadism of a known etiology. Children with combined hormone deficiencies are permitted to enroll (but the child must already be receiving treatment for concomitant hormonal deficiencies)

  2. Participants receiving prior testosterone treatment must be receiving a stable dose for at least 12 weeks prior to Screening. Treatment naive participants are permitted to enroll.

  3. Have parent(s) or a legal guardian who will voluntarily provide written informed consent for the child to participate in the study

  4. Willing to provide assent for participation in the study

  5. Be a male 12 to < 18 years of age at the time of consent/assent

  6. Have Legally Authorized Representative who is able to understand and comply with all study procedures and agrees to have the child participate in the study program as outlined in the protocol

  7. Requires chronic pharmacologic support for the initiation and/or continuation of pubertal maturation

  8. Have a body mass index (BMI)-for-age greater than the 5th percentile and weigh ≥ 30 kg.

  9. If sexually active with a female partner of child-bearing potential, agrees to:

    1. Practice true abstinence including 30 days after the last IP administration, or,
    2. Use 2 adequate forms of highly effective contraception, one of which should be a physical barrier, during the study and for 30 days after the last IP administration.

Exclusion Criteria:

  1. Has abnormal thyroid function tests at Screening. May supplement per usual clinical practice and rescreen up to two times.
  2. Has suspected or known constitutional growth delay in growth and puberty (CDGP)
  3. Has evidence of possible nutritional or gastrointestinal disorder that may impact growth (e.g., abrupt weight loss within the 3 months prior to Screening, unmanaged celiac disease, inflammatory bowel disease)
  4. Has a known allergy or hypersensitivity to XYOSTED, or to any of its ingredients (testosterone enanthate and sesame oil)
  5. Participants receiving prior treatment with testosterone who are not on a stable dose for at least 12 weeks prior to Screening.
  6. Has an allergy to foods or products containing sesame seeds or sesame oil
  7. Has Stage 1 hypertension, defined as the average of 2 or more seated right arm BP measurements exceeding the 95th percentile for age, sex, and height, or SBP ≥ 130 mm Hg and/or DBP ≥ 80 mm Hg at Screening or Day 1.
  8. Has a clinically significant abnormal clinical laboratory test value at Screening, as determined by the Investigator including hematocrit > 48%, or >50% for patients living at high altitude if not receiving testosterone treatment, or hematocrit > 52% if already receiving testosterone treatment.
  9. Has a history of deep venous thrombosis or pulmonary embolism
  10. Has evidence of a clinically significant 12-lead electrocardiogram (ECG) abnormality at Screening, as determined by the Investigator
  11. Has a current suspected or diagnosed (and unresected) tumor of the pituitary gland with the exception of Rathke's cleft cyst or a stable non-functioning pituitary microadenoma (ie, lesion size < 10 mm that has not increased in size over a period of 1 year on repeat imaging), as determined by the Investigator
  12. Has an active malignancy or has received treatment for a malignancy within the 12 months before Screening
  13. Is currently receiving antipsychotic medication for any reason or is currently receiving selective serotonin reuptake inhibitor (SSRI) medication for depression
  14. Is receiving any other medication or has a condition that would preclude safe participation in the study or confound the evaluation of safety, as determined by the Investigator
  15. Has a history of suicidal behavior (i.e., actions intended to harm oneself), suicidal ideation (i.e., thoughts and plans about suicide), or suicide attempts
  16. Has any affirmative responses on the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire to questions #3, #4, or #5 or any affirmative response to questions #1 or #2 within the past 12 months on the suicide ideation questions (first section) OR any affirmative response on the suicidal behavior questions (the second section).
  17. Is currently taking supraphysiologic doses of systemic glucocorticoids for more than 3 weeks, except for intermittent short courses of exogenous glucocorticoids as needed for the treatment of asthma
  18. Has received any other investigational compound within 1 month prior to screening or 5 half-lives of the investigational product (whichever is longer)
  19. Has received gonadotropin-releasing hormone (GnRH) agonists, aromatase inhibitors, androgens (eg, dehydroepiandrosterone [DHEA]), anabolic steroids such as oxandrolone, or other sex steroids within 12 months before the Screening visit, or would require these treatments at any time during the study.
  20. Receiving cytochrome P450 (CYP) 3A4 or P glycoprotein (P-gp) inhibitors/inducers or medications that are metabolized by CYP3A4 or P-gp within 30 days of enrolment.
  21. Has a history of alcohol or drug abuse
  22. Has a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other conditions that would preclude participation in the study, as determined by the Investigator
  23. Has chronic urticaria or dermatographism
  24. Has 25-hydroxy-vitamin D blood level < 20 ng/mL. Participants with initial vitamin D blood measurement < 20 ng/mL may enroll while they receive supplementation per clinical practice

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Participants

XYOSTED Injection (Testosterone enanthate) 25 mg / 0.5 mL, 50 mg / 0.5 mL, 75 mg / 0.5 mL, 100 mg / 0.5 mL
Kombinationsprodukt: Testosterone enanthate

XYOSTED 25 mg / 0.5 mL; XYOSTED 50 mg / 0.5 mL; XYOSTED 75 mg / 0.5 mL; XYOSTED 100 mg / 0.5 mL

Andre navne:
  • XYOSTED Injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Forøgelse af testosteron, som vurderet ved hjælp af PK-parametre
Tidsramme: Fra tilmelding til afsluttende undersøgelsesvurderinger i uge 53
Fra tilmelding til afsluttende undersøgelsesvurderinger i uge 53

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of participants demonstrating either progression through Tanner Stages of puberty or attainment of Tanner Stage 5 by the end of the study
Tidsramme: End of Study Assessment at Week 53

Evaluated through clinical//physical examination
End of Study Assessment at Week 53
• Percentage of patients that had an increase in stretched penile length
Tidsramme: End of Study Assessment at Week 53

Evaluated through clinical//physical examination
End of Study Assessment at Week 53
Change from Screening or Baseline in DEXA bone density for total body less head (TBLH) and PA spine
Tidsramme: End of Study Assessment at Week 53

Evaluated through DEXA scan using age-appropriate software
End of Study Assessment at Week 53
Change from Screening or Baseline in body composition by DEXA scan
Tidsramme: End of Study Assessment at Week 53

Evaluated through DEXA scan using age-appropriate software
End of Study Assessment at Week 53
Change from Screening or Baseline in bone age as determined by X-ray
Tidsramme: End of Study Assessment at Week 53

Evaluated through X-ray using central readers
End of Study Assessment at Week 53
Change from Screening or Baseline in BMI-for-age percentile
Tidsramme: End of Study Assessment at Week 53

Evaluated through clinical//physical examination
End of Study Assessment at Week 53
• Change from Screening or Baseline in Height Velocity (HV)
Tidsramme: End of Study Assessment at Week 53

Evaluated through clinical//physical examination
End of Study Assessment at Week 53

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PK endpoints
Tidsramme: End of Study Assessment at Week 53

Total Testosterone concentration
End of Study Assessment at Week 53
Evaluation of Safety Endpoints including Treatment-Emergent Adverse Events
Tidsramme: End of Study Assessment at Week 53

Frequency and Severity of TEAEs
End of Study Assessment at Week 53

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Halozyme Therapeutics

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. marts 2025

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

1. marts 2030

Datoer for studieregistrering

Først indsendt

6. november 2024

Først indsendt, der opfyldte QC-kriterier

13. november 2024

Først opslået (Faktiske)

14. november 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ATRS QST-19-007

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner