To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection

Официальное название

A Multicenter, Randomized, Double-blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Follicle-stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection in Idiopathic Hypogonadotropin Hypogonadism

Обзор

This study was conducted to evaluate recombinant human follicle stimulating hormone-CTP fusion protein injection or placebo combined with chorionic gonadotropin for injection

Подробное описание

A multicenter, randomized, double-blind, Phase III clinical study to evaluate the efficacy and safety of recombinant human follicle-stimulating hormone-CTP Fusion protein injection or placebo combined with chorionic gonadotropin for injection to initiate or restore puberty in idiopathic hypogonadotropin hypogonadism in adolescent males aged 14 to 18 years.

Вмешательства

• Препарат recombinant human follicle-stimulating hormone-CTP Fusion protein injection
  IF Weight \> 60kg，150ug, H. Administer the drug once every 14 days for 64 weeks；IF Weight \>≤60kg，100ug, H. Administer the drug once every 14 days for 64 weeks
• Препарат recombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo
  0.5ml, H. Administer the drug once every 14 days for 64 weeks

Первичные конечные точки

• Change from baseline in testicular volume (the sum of the volumes of the left and right testes measured on ultrasonography) after 64 weeks [Срок оценки: 64 weeks after administration]

Критерии участия

Критерии включения

• The guardian and subject are aware of the study procedures, available alternative treatments, and the risks of participating in the study, and voluntarily sign a written ICF to voluntarily participate in the study.
• Age 14-18 years old (excluding 18 years old) at the time of signing the ICF, with bone age greater than 12 years old.
• Height ≥145cm and body mass index (BMI) < 30kg/m2 when signing ICF.
• Diagnosis of idiopathic or congenital hypogonadotropic hypogonadism.
• The presence of bilateral pre-gonadal onset testis during the screening period: testicular volume <4 mL on each side (determined by ultrasound and evaluated by 2 qualified ultrasound specialists authorized by the researchers of the research center).
• The circulating gonadotropin (Gn) level was low (FSH≤1 IU/L and LH≤1 IU/L) during the screening period, and the peak LH value of GnRH excitation test was ≤4 IU/L.
• Serum testosterone T ≤ 1 ng/mL during the screening period.
• The normal range of other pituitary hormones during the screening period (judged by the researcher).
• Lesions detected by MRI on the head within 3 months before or during screening were normal or determined by the investigator to have no impact on the study.
• Consent to the use of reliable contraception (e.g. abstinence, condoms, etc.) by yourself and your sexual partner during the study period and for 3 months after the study drug treatment.

Критерии исключения

There is primary hypogonadism (e.g., Klinefelter syndrome).

• Hypogonadotropic hypogonadism caused by tumor, surgery, trauma, infection, or immune factors in the hypothalamic sella or pituitary gland.
• History of unilateral or bilateral cryptorchidism and the presence of clinically significant testicular lesions (orchitis, testicular tumor, testicular torsion, severe varicocele (grade III), testicular atrophy, obstructive azoospermia, etc.).
• Researchers identified uncontrolled endocrine diseases, including thyroid, adrenal diseases, diabetes, etc.
• History of malignant tumors within 5 years prior to the screening period.
• Patients who have received GnRH, gonadotropin or oral androgen (testosterone, etc.) therapy within 1 month before signing ICF, or who have received testosterone undecanoate intramuscular injection therapy within 1 year before signing ICF.
• History of drug or substance abuse within 1 year prior to signing the ICF, drugs known to impair testicular function or affect the production of sex hormones, or alcohol abuse.
• Abnormal liver and kidney function during screening, i.e. liver function: alanine aminotransferase and/or aspartate aminotransferase higher than 2 times the upper limit of normal (>2×Upper limit of normal); Renal function: Creatinine and/or urea/urea nitrogen are 2 times higher than the upper limit of normal (>2×Upper limit of normal).
• During the screening period, patients with systemic diseases (such as metabolic abnormalities, circulatory, digestive, nervous system, etc.) judged by the researchers are not suitable for participation in this study.
• Current thromboembolic disease or known prior history.
• Hepatitis B surface antigen, hepatitis C antibody, HIV antibody and treponema pallidum antibody positive.●
• People who are allergic to the active ingredients or excipients of FSH and hCG drugs or have a history of related allergies, or have a clear contraindication of drug use.
• Participants who participated in other interventional clinical trials and used experimental drugs within 3 months prior to screening.
• Patients with a history of depression or mental disorders.
• Due to risk considerations, the researchers did not consider it appropriate to participate in other situations in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 17 центров

• Anhui Children's Hospital — Хэфэй
• Beijing Children's Hospital, Capital Medical University — Пекин
• Peking Union Hospital, Chinese Academy of Medical Sciences — Пекин
• The First Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Гуанчжоу
• Women and Children's Medical Center Affiliated to Guangzhou Medical University — Гуанчжоу
• Shenzhen Children's Hospital — Шэньчжэнь
• Henan Children's Hospital Zhengzhou Children's Hospital — Чжэнчжоу
• … и ещё 9 центров

Идентификаторы

NCT: NCT06561594 · GenSci094-303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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