A multicentre, randomised, double-blind placebo-controlled, phase II study to evaluate the safety, tolerability and dose of dried intestinal microbiota medicinal product EBX-102 in liver cirrhosis subjects (IMPuLCE)

Caidya0 个研究点目标入组 60 人开始时间: 2023年8月23日最近更新: 2023年9月18日

适应症

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方
入组人数: 60

研究概览入排标准研究者记录与标识符相似试验

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. Willing and able to provide informed consent
•2. Male or female aged =18 years
•3. A clinical diagnosis of LC, as confirmed by confirmatory scan (magnetic resonance imaging [MRI], 4. ultrasound, computed tomography [CT] or transient elastography) and/or needle biopsy of the liver. A needle biopsy is not a mandated procedure for study purposes.
•5. (Part B only) Must be clinically stable on lactulose as deemed by the investigator for at least 1 month prior to randomisation, with the intent to remain on stable dose of treatment throughout the study period. Small daily variations of lactulose are permitted and must be recorded.
•6. Subjects taking rifaximin should be stable at the prescribed dose for at least 4 weeks prior to randomisation.
•7. MELD-Na score: 5.a - Part A: MELD-Na score of <12 5.b - Part B: Minimum MELD-Na score of 12 and a maximum MELD-Na score of 16.
•8. Willing to abstain from consuming regular ‘over the counter’ pre or probiotics from pharmacies or other retailers from screening through to Week 12 after treatment.
•9. Food products such as cheese, yoghurts, fermented pickles and probiotic drinks from the food section of supermarkets are acceptable.
•10. Subjects with an alcohol use disorder should be willing to abstain from alcohol during the screening, treatment and follow up period.
•11. Where subjects do not have an alcohol use disorder, alcohol may be consumed within the National Health Service (NHS) guidelines of =14 units per week, spread over at least 3 days per week.
•12. Subjects with any other substance use disorder should be willing to abstain from those and other related substances, including substitutes, during the screening, treatment and follow up period.
•13. Subjects with any substance or alcohol use disorder must have abstained from substance use for =3 months prior to screening. If women of child-bearing potential (WOCBP), subjects must have a negative serum pregnancy test at screening and randomisation and must be willing to use a highly effective method of birth control for the duration of the study.
•14. Acceptable methods of contraception:
•14.1. Hormonal contraception associated with inhibition of ovulation
•14.2. Intrauterine device (IUD)
•14.3. Intrauterine hormone-releasing system (IUS)
•14.4. Bilateral tubal occlusion
•14.5. Vasectomised partner
•14.6. Condom with spermicide
•14.7. Sexual abstinence, in line with the preferred and usual lifestyle of the subject.
•15. Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
•16. If male, subjects must be prepared to use reliable barrier method contraception and a second method such as spermicide for the duration of the study unless surgically sterile.
•17. Willing and able to comply with all study requirements

排除标准

•Subjects will be excluded from the study if they meet any of the following:
•1. OHE as defined by Grade =2 WHG within 1 month of screening.
•2. Part A only: any prior episode of HE
•3. Overnight admission to hospital with OHE or any other liver-related complication, or any other non-elective admission to hospital, within the 4 weeks prior to screening.
•4. Planned surgery requiring general anaesthetic during the course of the study.
•5. History of total colectomy/ileostomy at any time, or bariatric/gastric surgery in the last 2 years.
•6. Any other major intra-abdominal surgery within 60 days prior to screening
•7. Confirmed diagnosis of Wernicke’s Encephalopathy (WE) at any time prior to screening (prophylaxis of WE at any time prior to or during the study in accordance with the standard of care, with no confirmed diagnosis is permitted)
•8. Korsakoff’s Disease at any time prior to screening.
•9. Confirmed diagnosis of dementia of any aetiology
•10. Clinical signs and symptoms of dehydration at screening or baseline.
•11. Any ongoing underlying issues which increase the risk of an OHE episode (e.g. unresolved gastrointestinal [GI] bleed; ongoing bacterial infection) at screening or baseline.
•12. Diarrhoea of any aetiology within 7 days prior to screening.
•13. Any anti-diarrhoeal or anti-peristaltic medication within 7 days prior to screening
•14. Medications for HE
•14.1. – Part A: medications for HE, including but not limited to lactulose, rifaximin, LOLA, BCAAs or other antibiotics. Rifaximin use for other conditions is also excluded.
•14.2. – Part B: Part B: Medications for hepatic encephalopathy, including but not limited to: LOLA, BCAAs or antibiotics other than rifaximin within 3 months prior to screening. Lactulose is mandated.
•15. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =4 x ULN
•16. Planned organ transplant during the study period.
•17. Chemotherapy, radiotherapy or immunotherapy within 3 months prior to baseline, or planned during the study
•18. Life expectancy <4 months
•19. Ongoing infectious hepatitis (A, B or C) or recent history that has not fully resolved at least 3 months prior to screening
•20. Any other known immunodeficiency, including human immunodeficiency virus (HIV) with CD4+ T-cell counts <500 cells/mm3
•21. Known gastrointestinal disease, including but not limited, to ulcerative colitis, Crohn’s disease, coeliac disease, indeterminate colitis or microscopic colitis, diverticulitis, IBS.
•22. Use of systemic antibiotics within 3 months prior to screening, or intended use during the study, with the exception of stable rifaximin for Part B subjects.
•23. Patients receiving total parenteral or enteral nutrition. Nutritional supplements are permitted, with the exception of non-food pre- or probiotics.
•24. Any autoimmune disease requiring, or that may require, systemic treatment with steroids and/or other immunosuppressants/immunomodulators and/or biological agents including SLE, RA, psoriatic arthritis and connective tissue disorders and MS. Autoimmune hepatitis is also excluded. Subjects with mild autoimmune disease not requiring systemic treatment, including vitiligo and alopecia areata, may be included.
•25. Use of systemic steroids within the previous four weeks (inhaled and topical steroids are acceptable).
•26. Uncontrolled Type I or Type II diabetes mellitus that has required hospitalisation within the last 3 months or, in the opinion of the investigator would lead to increased risk to the subject

研究者

发起方

Caidya

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