Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT06561594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-20
First Post:
2024-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562785', 'term': 'Idiopathic Hypogonadotropic Hypogonadism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'recombinant human follicle-stimulating hormone-CTP Fusion protein injection or placebo combined with chorionic gonadotropin for injection'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-12-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2024-08-15', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in testicular volume (the sum of the volumes of the left and right testes measured on ultrasonography) after 64 weeks', 'timeFrame': '64 weeks after administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Hypogonadotropic Hypogonadism']}, 'descriptionModule': {'briefSummary': 'This study was conducted to evaluate recombinant human follicle stimulating hormone-CTP fusion protein injection or placebo combined with chorionic gonadotropin for injection', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '14 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Age 14-18 years old (excluding 18 years old) at the time of signing the ICF, with bone age greater than 12 years old.\n* Height ≥145cm and body mass index (BMI) \\< 30kg/m2 when signing ICF.\n* Diagnosis of idiopathic or congenital hypogonadotropic hypogonadism.\n* 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).\n* 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.\n* Serum testosterone T ≤ 1 ng/mL during the screening period.\n* The normal range of other pituitary hormones during the screening period (judged by the researcher).\n* 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.\n* 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.\n\nExclusion Criteria:\n\nThere is primary hypogonadism (e.g., Klinefelter syndrome).\n\n* Hypogonadotropic hypogonadism caused by tumor, surgery, trauma, infection, or immune factors in the hypothalamic sella or pituitary gland.\n* 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.).\n* Researchers identified uncontrolled endocrine diseases, including thyroid, adrenal diseases, diabetes, etc.\n* History of malignant tumors within 5 years prior to the screening period.\n* 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.\n* 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.\n* 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).\n* 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.\n* Current thromboembolic disease or known prior history.\n* Hepatitis B surface antigen, hepatitis C antibody, HIV antibody and treponema pallidum antibody positive.●\n* 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.\n* Participants who participated in other interventional clinical trials and used experimental drugs within 3 months prior to screening.\n* Patients with a history of depression or mental disorders.\n* Due to risk considerations, the researchers did not consider it appropriate to participate in other situations in this study.'}, 'identificationModule': {'nctId': 'NCT06561594', 'briefTitle': 'To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun GeneScience Pharmaceutical Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'GenSci094-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': '30subjects：GenSci094 was administered for 12 weeks，150ug/0.5ml（weight\\>60kg）or 100ug/0.5ml（weight≤60kg）；GenSci094 with chorionic gonadotropin for injection was administered for 52 weeks，150ug/0.5ml（weight\\>60kg）or 100ug/0.5ml（weight≤60kg）with chorionic gonadotropin for injection.', 'interventionNames': ['Drug: recombinant human follicle-stimulating hormone-CTP Fusion protein injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': '30subjects：GenSci094 Placebo was administered for 12 weeks，150ug/0.5ml（weight≥60kg）or 100ug/0.5ml（weight\\<60kg）；GenSci094 Placebo with chorionic gonadotropin for injection was administered for 52 weeks，150ug/0.5ml（weight≥60kg）or 100ug/0.5ml（weight\\<60kg）with chorionic gonadotropin for injection.', 'interventionNames': ['Drug: recombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo']}], 'interventions': [{'name': 'recombinant human follicle-stimulating hormone-CTP Fusion protein injection', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Experimental group']}, {'name': 'recombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo', 'type': 'DRUG', 'description': '0.5ml, H. Administer the drug once every 14 days for 64 weeks', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230022', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': "Anhui Children's Hospital", 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100045', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Beijing Children's Hospital, Capital Medical University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'xueyan Wu, Doctor of Medicine', 'role': 'CONTACT', 'email': 'wsheyan@vip.sina.com', 'phone': '010-69154116'}], 'facility': 'Peking Union Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen Memorial Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510623', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Women and Children's Medical Center Affiliated to Guangzhou Medical University", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '518026', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': "Shenzhen Children's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '450018', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': "Henan Children's Hospital Zhengzhou Children's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '210093', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': "Nanjing Children's Hospital", 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '330200', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': "Jiangxi Children's Hospital", 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shengjing Hospital affiliated to China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '272100', 'city': 'Jining', 'state': 'Shangdong', 'country': 'China', 'facility': 'Affiliated Hospital of Jining Medical College', 'geoPoint': {'lat': 35.405, 'lon': 116.58139}}, {'zip': '200062', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Children's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200125', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Affiliated Pediatric Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610073', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Chengdu Women and Children's Central Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'lingling Li', 'role': 'CONTACT', 'email': 'lilingling01@genscigroup.com', 'phone': '+86-18826108784'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changchun GeneScience Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}