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临床试验/EUCTR2017-000488-34-IT
EUCTR2017-000488-34-IT进行中(未招募)1 期

RIFAXIMIN BLUNTED HIGHER LEVELS OF ENDOTOXIN IN CIRRHOSIS PATIENTS: A RANDOMIZED, DOUBLE BLIND, SHORT TERM INTERVENTIONAL TRIAL. - Rifaximin in cirrhotic patient

MBERTO I - POLICLINICO DI ROMA0 个研究点目标入组 40 人开始时间: 2021年6月8日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Inclusion criteria will be: (i) patients aged 18–75 years; (ii) those with decompensated liver cirrhosis, as confirmed by clinical symptoms and signs, laboratory results, ultrasound and spiral computed tomography (CT) (Child–Pugh grade B or C).
  • 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 20
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • Exclusion criteria will be: i) presence of overt infection or sepsis; ii) treatment with systemic or non-absorbable antibiotic, aspirin or other non-steroidal anti-inflammatory drugs, antidepressant drugs in the previous 30 days; iii) recent need of transfusion of platelets or plasma; iv) presence of extra-hepatic malignancy; v) active alcohol intake in the last 6 months; vi) pregnancy or breast feeding; (v) presence of overt HE, GI haemorrhage, SBP or other concurrent infections during the previous one month; (v) human immunodeficiency virus (HIV) infection; (vi) chronic renal and/or respiratory insufficiency, severe heart disease; (vii) allergy to rifaximin.active post-viral hepatitis requiring or on direct-acting antiviral (DAA) agents; (ix) previous or active intestinal obstruction.

研究者

发起方
MBERTO I - POLICLINICO DI ROMA

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