5-Metyl-tetrahydrofolate in the treatment of portal hypertension in cirrhotics in pharmacologic prophylaxis of variceal bleeding with beta-blockers: a double-blind randomized controlled trial

AOU di Bologna Policlinico S.Orsola-Malpighi0 个研究点目标入组 60 人开始时间: 2014年10月16日最近更新: 2018年2月26日

适应症

试验速览

暂无简介。

•Liver cirrhosis demonstrated in terms of clinical, biochemical, imaging (echo-doppler upper abdomen, liver elastography). In the case of doubtful diagnosis is scheduled to run hepatic histology
•HVPG = 12 mmHg
•Presence of esophageal varices requiring the prophylaxis of bleeding from rupture (as indicated by guidelines Baveno V [7])
•Aged between 18 and 80 years
•Females and males
•Signature of informed consent
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Presence of HCC at the time of enrollment or within 3 months prior
•The presence of portal vein thrombosis at the time of enrollment or within 3 months prior
•Presence of acute infections or conditions compromising hemodynamic stability at the time of enrollment or during the previous month
•Serum creatinine> 2.5 mg / dL at enrollment
•Direct bilirubin> 6 mg / dL at enrollment
•Contraindications to beta-blockers at enrollment
•Women who are pregnant and / or lactating at the time of enrollment
•Known or suspected hypersensitivity to the drug or drug class in studio
•Patients with serious medical conditions at enrollment who, in the opinion of the investigator, contraindicate the patient's participation in the study
•Use of experimental drugs in the last 3 months before inclusion in the study
•Treatment for hepatitis C in place at the time of study or in the previous 3 months
•Treatment for hepatitis B undertaken by less than 3 months at the time of enrollment

发起方

AOU di Bologna Policlinico S.Orsola-Malpighi