Hepatorenal Syndrome Type 1 MedDRA version: 8.1 Level: LLT Classification code 10019846 Term: Hepatorenal syndrome
Conditions
Interventions
Trade Name: Haemopressin
Product Name: Terlipressin
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: terlipressin
Concentration unit: mg milligram(s)
Concentration type: equal
Pharmaceu
Sponsors
Curatis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to demonstrate that intravenous terlipressin is safe and effective in the treatment of patients with hepatorenal syndrome (HRS) type 1 when compared to placebo with regard to treatment success at 14 days, i.e., survival with a reversal of HRS to serum creatinine values at or below 1.5 mg/dL;Secondary Objective: to demonstrate that terlipressin improves renal function and survival compared to placebo;Primary end point(s): Incidence of treatment success at day 14, defined as the percentage of patients alive with reversal of HRS (serum creatinine at or below 1.5 mg/dL, with at least 2 measurements 48 ± 2h apart), without dialysis or recurrance of HRS. | — |
Countries
Germany
Outcome results
None listed