Two treatment strategies with Ribavirin for Chronic Hepatitis E and severe acute forms randomized study

Fundació Hospital Vall Hebron Institut de Recerca0 个研究点目标入组 56 人开始时间: 2015年7月10日最近更新: 2018年11月19日

试验速览

暂无简介。

•- 18 years old or above.
•- That meet one of the following two diagnostics:
•a) chronic Hepatitis E: HEV RNA detectable in patients with elevated transaminase levels for at least 6 months and / or HEV RNA detectable in two separated by an interval of six months determinations.
•b) Severe acute hepatitis E: ALT levels greater than 10 times the normal limit , HEV RNA positive , and signs of acute liver injury (INR > 1.5) ; or extrahepatic manifestations or liver failure in patients with previous liver disease.
•- Signed 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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•- Terminal illness with a life expectancy of less than six months.
•- Patients with contraindications for treatment with Ribavirin :
•a) Pregnancy or breastfeeding
•b) Hepatic serious insufficiency or unbalanced cirrhosis.
•c) Hemoglobinopathies ( thalassemia , sickle cell anemia ) .
•d) History of severe pre-existing cardiac disease , including unstable heart disease .

发起方

Fundació Hospital Vall Hebron Institut de Recerca