A double-blind, randomized, placebo-controlled, multicenter phase III study of intravenous terlipressin in patients with hepatorenal syndrome type 1

Curatis Pharma GmbH0 个研究点目标入组 120 人开始时间: 2006年8月11日最近更新: 2012年3月19日

试验速览

暂无简介。

•1. Provide written informed consent by patient or legal representative before initiation of any study related procedures.
•2. At least 18 years old
•3. Chronic liver disease.
•4. Acute liver disease, i.e. de novo onset within 6 weeks; e.g. viral and/or alcoholic hepatitis (see also exclusion criteria 6).
•5.Rapidly progressive reduction in of renal function, e.g. doubling of serum creatinine to >2.5mg/dL in less than 2 weeks prior to HRS diagnosis, or a 50% reduction of the initial 24 hour creatinine clearance to a level lower than 20 mL/min.
•6. Low GFR, as indicated by serum creatinine >1.5 mg/dL, or 24 h creatinine clearance of <40mL/min
•7. No sustained improvement in renal function (decrease of serum creatinine to 1.5mg/dL or less or increase in creatinine clearance to 40mL/min or more) after diuretic withdrawal and plasma volume expansion with 1.5 L isotonic saline.
•8. Proteinuria lower than 500 mg/dL per day
•9. No evidence of granular casts on urinalysis
•10. No ultrasonographic evidence of obstructive uropathy or parenchymal renal disease
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Ongoing Shock
•2. Uncontrolled (ongoing) bacterial infection
•3. Current fluid losses, i.e. GI fluid losses (repeat vomiting or intense diarrhea) or renal fluid losses (eg weight loss >500g/d for several days in patients with ascites without peripheral edema or 1000 g/d in patients with peripheral edema)
•4. Current or recent treatment with nephrotoxic drugs, eg aminoglycosides, NSAIDs within 4 weeks
•5. Estimated life expectancy of less than 3 days
•6. Acute liver disease due to factors known to be also directly nephrotoxic (e.g. acetaminophen overdose, mushroom [Amanita] poisoning)
•7. Confirmed pregnancy
•8. Severe cardiovascular disease as judged by investigator
•9. Evidence of intrinsic or parenchymal renal disease (eg acute tubular necrosis)
•10. Known allergy to terlipressin, or known sensitivity to any component of the products
•11 Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization.

发起方