EUCTR2013-000563-81-ES进行中（未招募）不适用
Metformin treatment of minimal hepatic encephalopathy in patients with liver cirrhosis - EME
FUNDACION PUBLICA ANDALUZA PARA LA GESTION DE LA INVESTIGACION EN SALUD DE SEVILLA0 个研究点开始时间: 2013年6月26日最近更新:
适应症
试验速览
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
- •Men and women aged 18 years. Diagnosis of EHM, introducing at least one of the following alterations:
- •FCP <39 Hz Diagnosis of liver cirrhosis by imaging techniques (ultrasound, CT computeriazada, MRI) or liver biopsy (Metavir classification F4). In women of childbearing potential, negative pregnancy test. Effective contraceptive measures during treatment and for 6 months after treatment ends.
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who have experienced an episode of hepatic encephalopathy before the start of the study. Patients with type 1 diabetes mellitus. Patients with type 2 diabetes mellitus treated with insulin, metformin or any other oral antidiabetic. Patients treated with benzodiazepines. Pregnant or breastfeeding. Systemic antineoplastic treatment or immunomodulators (including steroids and supraphysiological doses of radiation) 6 months prior to the first dose of treatment. Treatment with any investigational drug within 6 weeks prior to the first dose of treatment. Signs or symptoms of hepatocellular carcinoma. Background or other evidence of bleeding from esophageal varices. Neutrophil count <1500 cells/mm3 or a platelet count <90,000 cells/mm3 at the time of screening. Hgb <10 at the time of evaluation. Patients with documented or suspected coronary artery disease or cerebrovascular disease should not be treated if in the judgment of the investigator, could see their conditions worsened during the study. Serum creatinine> 1.5 times the upper limit of normal at the time of evaluation. History of severe psychiatric illness, particularly depression. It is defined as a severe psychiatric disorder that requires treatment with antidepressants or major tranquillizers in therapeutic doses required for major depression or psychosis, respectively, for at least three months at any time before or any of the following background: attempted suicide, hospitalization for of psychiatric illness, or disability period due to psychiatric illness. Background severe seizure disorder or current use of anticonvulsants. History of autoimmune disease, chronic lung disease associated with limited functionality, serious heart disease, congestive heart failure, advanced arteriosclerosis, increased organ transplant or other indications of serious disease, neoplasia, or any other condition that, in the opinion of the investigator, would prevent the patient is suitable for the study. History of thyroid disease poorly controlled with medications prescribed, elevated thyroid stimulating hormone (TSH) with increased thyroid peroxidase antibodies and any clinical manifestations of thyroid disease. Acute conditions involving a risk of impaired renal function: dehydration (diarrhea, vomiting), fever, infectious conditions and / or severe hypotonic (shock, sepsis, urinary tract infection, neuropathy).
- •Radiological examination with intravenous administration of contrast media (IVP, angiography). Evidence of drug use in the six months preceding the survey. Alcohol. Inability or unwillingness to give informed consentiomiento or to meet the requirements of the study.
研究者
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