[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yilai Shu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100571585","a-study-of-eh002-gene-therapy-for-otoferlin-gene-mutation-mediated-hearing-loss-100571585",false,"NCT06722170","A Study of EH002 Gene Therapy for Otoferlin Gene Mutation-mediated Hearing Loss","A Study on the Safety, Tolerability, and Preliminary Efficacy of EH002 in the Treatment of DFNB9 Congenital Deafness","Inclusion Criteria:\n\n1. The participant and\u002For their legal guardian must provide informed consent before the study, voluntarily sign the written informed consent form, and be willing to attend follow-up visits as scheduled by the study.\n2. The participant must communicate effectively with the investigator and comply with the investigator's requirements, with the assistance of a legal guardian if necessary. Young children without mature language skills must be able to cooperate and comply with the investigator's requirements with the help of a legal guardian.\n3. The participant and\u002For legal guardian must understand the study correctly and have appropriate expectations regarding the potential benefits.\n4. The participant must be at least 6 months old, with no restrictions on gender.\n5. The participant must be diagnosed with DFNB9 congenital deafness, confirmed by genetic testing showing homozygous or compound heterozygous mutations in the OTOF gene.\n6. Audiological inclusion criteria: Severe or profound hearing loss (≥65 dB).\n7. The participant must meet the surgical requirements, including the absence of middle- or inner-ear malformations, vestibulocochlear nerve developmental abnormalities, and ear inflammation, as confirmed by CT or MRI scans within 3 months or at the time of screening. Additionally, the participant must be deemed eligible for surgery.\n\nExclusion Criteria:\n\n1. The genetic diagnosis does not indicate an OTOF mutation.\n2. Other types of deafness that are unsuitable for otological surgery, such as middle- or inner-ear developmental abnormalities or malformations, vestibulocochlear nerve abnormalities, conductive hearing loss, mixed hearing loss, or malformation syndromes, as detected by CT or MRI scans within 3 months.\n3. Pre-existing otological conditions that would interfere with the planned surgery or the interpretation of study endpoints, such as acute or chronic otitis media, Meniere's disease, acoustic neuroma, or unrecovered sudden sensorineural hearing loss.\n4. A history of substance abuse, or treatment with any known ototoxic drugs (e.g., aminoglycosides, cisplatin, loop diuretics) within the last 6 months, or antiviral medications or immunotherapy within the last 3 months, or vaccination within the last month.\n5. Individuals with compromised immunity or a history of immunodeficiency, including HIV-positive status, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.\n6. Patients with severe systemic diseases or severe acute illnesses, such as tuberculosis, active hepatitis B or C infection, active herpes zoster infection, pancreatitis, renal insufficiency, or gastrointestinal ulcers.\n7. Patients with surgical or anesthetic contraindications as determined by the surgeon, anesthesiologist, or designated personnel. This includes those who have had a cardiovascular or cerebrovascular event within the last 6 months, such as myocardial infarction, heart failure, angina, stroke, transient ischemic attack, or any other cardiac condition deemed unsuitable by the investigator or an allergy to any planned medications.\n8. Currently participating in or planning to participate in any interventional clinical trial involving drugs or devices within the next year or having received the last dose of another clinical trial within 5 half-lives.\n9. Presence of an implant in the ear (on the side intended for surgery) at the time of screening, such as a cochlear implant.\n10. Neutralizing antibody titer against AAV1 \\>1:2000.\n11. Presence of other severe congenital disorders.\n12. A history of definite neurological or psychiatric disorders, including epilepsy or dementia.\n13. Patients requiring long-term anticoagulant therapy that cannot be temporarily discontinued.\n14. A history of chemotherapy or radiation therapy.\n15. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this clinical study.","ALL","6 Months",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"NA","The study is designed to evaluate the safety, tolerability, and preliminary efficacy of EH002 for the treatment of congenital deafness caused by mutations in the OTOF gene. Participants may receive one or two injections of the EH002 gene therapy in one or both ears.",[26,27,28],"DFNB9","Congenital Hearing Loss","Hearing Loss, Sensorineural","RECRUITING","2025-07-22",{"date":32,"type":33},"2025-07-25","ACTUAL",{"date":35,"type":33},"2024-11-22",{"date":37,"type":20},"2029-11",{"name":39,"class":40},"Yilai Shu","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100593923","a-clinical-trial-of-the-safety-and-efficacy-of-tj0113-capsules-in-the-treatment-of-patients-with-age-related-hearing-loss-100593923","NCT07012746","A Clinical Trial of the Safety and Efficacy of TJ0113 Capsules in the Treatment of Patients With Age-related Hearing Loss","A Randomized, Double-Blind, Placebo-Parallel-Controlled Clinical Trial to Explore the Safety and Efficacy of TJ0113 Capsules in the Treatment of Patients With Age-related Hearing Loss","Inclusion Criteria:\n\n1. The subjects voluntarily participate in the clinical trial, sign the informed consent form, understand and follow the protocol, and fully understand the test content, process and possible adverse reactions.\n2. Age between 65 and 80 years (including the critical value)\n3. A diagnosis of symmetrical sensorineural deafness (SNHL) with a history of\\> 3 months (binaural threshold difference in mean PTA frequency \\\u003C15 dB HL), the PTA level should be between moderate (\\> 35dB) and severe (\\\u003C80dB) hearing loss\n4. Hearing aids have not been used, or otherwise, it should be used regularly for more than 3 years and stopped for 3 months before enrollment.\n5. Subjects and their partners had no birth plan, sperm or egg donation plans from the screening period until within 6 months after the end of the trial and would voluntarily take effective contraception (e. g. abstinence, condoms, etc.). Male subjects should agree to avoid sperm donation within 6 months from the start of administration until cessation of study treatment. Female subjects should be menopausal (over 24 months).\n\nExclusion Criteria:\n\n1. The presence of implants in the study ear (such as cochlear implant, artificial hearing bone, etc.);\n2. Suffering from acute otitis media or other ear infection within the previous 3 months or previous chronic suppurative otitis media or tympanic membrane perforation, or with conductive deafness, previous history of ear trauma or surgery, combined middle ear or inner ear malformation, otosclerosis, Meniere's disease, sudden deafness and no recovery of hearing, all of which will impact results explained.\n3. Patients with sensorineural deafness caused by non-aging factors (e. g., hereditary deafness, congenital deafness, drug-induced deafness, noise deafness, neurosyphilis, severe retrocochlear lesions or organic lesions), and unilateral deafness\n4. Occupation that is sensitive to sound: musician, conductor, music teacher, etc.\n5. Use headphones at high volume or frequent exposure to noise in previous work or life;\n6. History of alcohol or drug dependence \u002F drug abuse in the last 1 year;\n7. Positive pregnancy test at screening or at the baseline visit, pregnant, lactating, or planned to become pregnant during the trial\n\n7.Failure to swallow oral medication, or, according to the investigator, any conditions that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or that may pose a hazard to the subjects participating in this trial; 9.People who currently taking drugs that can improve symptoms such as dementia and depression 10.Subjects with a severe or unstable systemic disease, such as serious congenital disease, blood disease, endocrine disease, nerve or nervous system disease, end-stage disease, head and neck tumor radiotherapy and chemotherapy history, major surgical treatment, psychological disorders (severe insomnia, severe depression, severe anxiety, etc. diagnosed within the previous 90 days ) or history and clinical significance of abnormal baseline laboratory values, such as hepatic insufficiency (alanine transaminase (ALT) and \u002F or alanine transaminase (AST) is 2 times above the upper limit of the reference range, or renal insufficiency (creatinine clearance Ccr \\\u003C30 mL\u002Fmin), or history of malignant tumors and the detection results of tumor markers during the screening period have clinical significance, or unsuitable participants, as judged by the investigator; 11.Subjects suffering from any one of the following heart diseases: a. having uncontrolled or serious cardiovascular and cerebrovascular disease, including the development of grade II ( New York Heart Association, NYHA) or above congestive heart failure, unstable angina, acute myocardial infarction within 6 months before the first drug administration, or cardiac arrhythmias requiring treatment at screening; With b. hypertension (systolic pressure≥ 160mmHg and \u002F or diastolic v≥ 100mmHg), and after the combination of two or more antihypertensive drugs can not be reduced to the normal range; or c.with a history of clinically significant ECG abnormalities, the QRS time was\\> 120ms, Long QT syndrome: QTc interval\\> 450ms in male or QTc interval\\> 470ms in female.\n\n12.Participated in a clinical study involving the administration, device, or surgery of the study drug (new chemical entity) within 90 days or 5 half-lives (whichever is longer) 13.Patients with a previous history of hepatitis B, or any of the following indicators are positive at screening: hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody.\n\n14.The subject is not fit to participate in the study if the investigator considers. Or the subject could not participate in the trial for his own reasons, or the behavior subject may interfere with treatment, study or interpretation of results (e. g., previous treatment with high-dose aminoglycosides).","65 Years","75 Years",{"count":51,"type":20},60,[23],"The purpose of this study is to explore the safety and efficacy of TJ0113 capsules in patients with age-related hearing loss.",[55,56],"Age Related Hearing Loss","Deafness","NOT_YET_RECRUITING","2025-06-01",{"date":60,"type":33},"2025-06-10",{"date":62,"type":20},"2025-06-07",{"date":64,"type":20},"2027-04",{"name":39,"class":40},1,""]