CTIS2022-500121-33-01招募中1 期
A Phase 3 open-label, controlled, randomised, multi-centre trial comparing imlifidase and standard-of-care with standard-of-care alone in the treatment of severe anti-GBM antibody disease (Goodpasture disease) - 21-HMedIdeS-24
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 51
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •An anti-GBM antibody level which: •at last available assessment result is above a toxic level •constitutes an indication for intensive PLEX, Haematuria on dipstick and/or urinary sediment, eGFR(MDRD) <20 mL/min/1.73 m2, Patients aged =18 years, Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
排除标准
- •Diagnosis of anti-GBM disease more than 10 days prior to randomisation, Pregnancy or breast feeding, Start of PLEX more than 3 days prior to the day of randomisation if eGFR when starting PLEX was <20 mL/min/1.73 m2, Contraception: a)Men who are not vasectomised or abstinent or with a partner (of child-bearing potential) not willing to use one of the highly effective contraceptives listed below from screening to 6 months following discontinuation of CYC b)Men who are not willing to refrain from donating sperm from screening to 6 months following discontinuation of CYC c)Men who are not willing to use a condom during any form of sexual intercourse, regardless of a partner being of child-bearing potential from screening to 6 months following discontinuation of CYC d)Women of child-bearing potential not willing or not able to use at least one highly effective contraceptive method from screening to 12 months following discontinuation of CYC. In the context of this trial, a highly effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as: •combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral/intravaginal/transdermal) •progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable) •intrauterine device (IUD) •intrauterine hormone-releasing system (IUS) •bilateral tubal occlusion •vasectomised partner •true abstinence: When this is in line with the preferred and usual lifestyle of the patient. [Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception], Previous imlifidase treatment or known hypersensitivity to any of the excipients, Anuria for more than 24 hours at time of randomisation (Anuria is defined as < 100 mL urine produced during 24-hours), Any constituent of SoC (PLEX, glucocorticoids or immunosuppressive) given for treatment of rapidly progressing glomerulonephritis and/or pulmonary haemorrhage more than 7 days prior to randomisation, IVIg within 4 weeks before randomisation, History or presence of any medical condition or disease which, in the opinion of the investigator, may place the patient at unacceptable risk, or would jeopardise the interpretation of the imlifidase results due to severeness of the co-morbidity, Patients previously randomised in the study, Unsuitable to participate in the trial for any other reason in the opinion of the investigator
研究者
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