EUCTR2021-004323-33-CZ进行中（未招募）1 期
Phase II, Multi-Center, Randomized, Blinded Study Evaluating the Efficacy, Safety and Tolerability of a Single Intratympanic Dose of AC102 Compared to Oral Steroids for the Treatment of Idiopathic Sudden Sensorineural Hearing Loss
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Signed Institutional Review Board (IRB) / Independent Ethics
- •Committee (IEC) approved informed consent form (ICF)
- •2. Female or male patients aged between 18 and 85 years (inclusive) at the day of Screening
- •3. Unilateral ISSNHL
- •4. Onset of unilateral ISSNHL between 24 to 120 hours prior to
- •randomization
- •5. Patients with an absolute air conduction hearing threshold of at least 65 dB, but less than 100 dB (average of the three most affected consecutive frequencies between 0.25 and 8 kHz)
- •6. Patients with a relative hearing loss of at least 30 dB compared to the current audiogram of the non-affected ear (average of the three most affected consecutive frequencies between 0.25 and 8 kHz).
- •7. Willing and able to use adequate hearing protection and to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured for the duration of their participation in this study
- •8. Willing and able to protect the ear canal and middle ear from water exposure for as long as the tympanic membrane is not fully closed
- •9. Willing and able to attend the trial visits
- •10. Able to read and understand trial documents and follow Investigator and trial personnel instructions during visits. Willing and able to comply
- •with procedures of audiological assessments (in particular pure tone audiometry and speech audiometry)
- •11. Female patients must meet one of the following criteria:
- •o If of childbearing potential – have a negative urine pregnancy test and agree to use a highly effective medically accepted contraceptive method for at least 30 days after the last study medication intake
- •o If of non-childbearing potential – should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or bilateral
- •tubal ligation) or in a postmenopausal state (at least one year without menses at Screening)
- •Male patients with sexual partners who could become pregnant must meet the following criteria:
- •o Patient is unable to procreate, defined as surgically sterile (i.e. has undergone a vasectomy at last 6 months before Screening)
- •o Patient agrees to use one of the accepted contraceptive regimens for at least 30 days after the last study medication intake
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1. Insufficient handling of the language used in the speech audiometry tests
- •a) Bilateral hearing loss
- •b) Sudden hearing loss in the only hearing ear (i.e. pre-existing hearing loss in the contralateral ear of 40 dB or more measured by PTA in the range of 0.5-4 kHz)
- •3. Acute hearing loss from noise trauma, barotrauma or head trauma in either ear at any time
- •4. Congenital hearing loss
- •5. Conductive hearing loss or combined hearing loss (determined by a 4PTA > 10 dB). Only if the limit for bone conduction is reached, tympanogram type can be used (other than A).
- •6. Suspected perilymph fistula or round window membrane rupture in either ear
- •7. Otitis media or otitis externa that is ongoing or ended within 30 days prior to randomization or is occurring several times per year
- •8. Patients with abnormality of the tympanic membrane or the outer ear canal that would preclude intratympanic administration
- •9. Evidence or history of vestibular schwannoma (acoustic neuroma) or other retrocochlear damage in the affected ear
- •10. History of ISSNHL in the past 1 year in the affected ear
- •11. History of radiation-induced hearing loss, fluctuating hearing,
- •endolymphatic hydrops or Menière's disease in either ear
- •12. History of chronic inflammatory or chronic suppurative ear disease or
- •cholesteatoma in the affected ear
- •13. History of otosclerosis in the affected ear
- •14. Family history of hearing impairment other than age related
- •15. Medical History of one of the following diseases:
- •oHuman immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
- •oSystemic mycosis and parasitosis (amoebic or worm infections)
- •oAcute and chronic bacterial infections
- •oTuberculosis
- •oSevere osteoporosis
- •oNarrow and wide-angle glaucoma, corneal ulceration and corneal injury
- •oSevere ulcerative colitis with impending perforation, with abscesses or purulent inflammations
- •oExercise-induced angina, known class III or IV heart failure, as defined by the New York Heart
- •association (NYHA) functional classification system
- •oGastric or duodenal ulcer, existing or treated within <1 year prior to randomization
- •oMyasthenia gravis
- •oPatients with diagnosed anxiety disorders, psychosis, depression, schizophrenia, suicidal ideation or other significant psychiatric conditions. Inclusion only after critical evaluation by the Investigator
- •16.Uncontrolled systolic (>180 mmHg) or diastolic (>100 mmHg) blood pressure at Screening
- •17.Difficult to control diabetes
- •18.Treatment with medication listed in 4.4 of the protocol
- •19.Patients who have answered yes to questions 4 or 5 of the CSSRS
- •20.Hypersensitivity to prednisolone
- •21.Concurrent participation in another clinical study or participation in another clinical study within 30 days or 5 half-lives of the respective experimental drug (whichever is longer) prior to Screening Visit
- •22.Women who are breast feeding, pregnant or plan to become pregnant during the study or women of childbearing potential who are unwilling or unable to practice an effective method of contraception
- •23.Patients who are involved in the organization of the clinical investigation or are in any way dependent on the Investigator or Sponsor
- •24.Major surgery within eight weeks before Screening or scheduled/planned surgery within the time frame of the study
- •25.Medical reasons which, in the opinion of the Investigator, preclude inclusion in the study
- •26.Legal incapacity or limited legal capacity
- •27.Patients who have been committed to an institution by v
研究者
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