Pilot clinical trial phase I / IIa to determine condition, low dose and effectiveness of liver function tests (Hepatotest) - IIS-HEPA-TEST

INSTITUTO DE INVESTIGACION SANITARIA LA FE0 个研究点开始时间: 2014年5月22日最近更新: 2014年8月5日

适应症

试验速览

暂无简介。

•Group volunteers: volunteer subjects without severe liver pathology associated.
•Group patients: Patients who are to undergo abdominal surgery (liver resection preferably in the context of the underlying pathology, eg liver metastases, hepatic adenoma, cholangiocarcinoma, etc ...).
•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 70
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Group volunteers: under 18 years, pregnant and lactating women, allergy to any of the active substances or excipients, allergy to acetylsalicylic acid, liver pathology associated (cirrhosis, hepatitis, liver tumor pathology), moderate consumption of alcohol, renal failure (creatinine of 1.2mg/dl or less glomerular filtration of 90 ml / min).
•Group patients: below 18, allergy to any of the active ingredients or allergy to acetylsalicylic acid, renal failure (creatinine of 1.2mg/dl or less glomerular filtration of 90 ml / min), the appearance of other pathological conditions over study that contraindicate surgery. Pregnant women and lactating.

发起方

INSTITUTO DE INVESTIGACION SANITARIA LA FE