Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mallinckrodt
The primary objective of this trial is to confirm the efficacy and safety of intravenous terlipressin versus placebo in the treatment of adult subjects with hepatorenal syndrome (HRS) Type 1.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent by participant or legally authorized representative
Cirrhosis and ascites
Rapidly progressive worsening in renal function to a serum creatinine (SCr) at least 2.25 mg/dL and meeting a trajectory for SCr to double over 2 weeks
No sustained improvement in renal function (less than 20% decrease in SCr and SCr at least 2.25 mg/dL) at least 48 hours after diuretic withdrawal and the beginning of plasma volume expansion with albumin
Discontinues midodrine and octreotide before randomization if applicable
You may not be if
Serum creatinine level greater than 7.0 mg/dL
At least 1 event of large volume paracentesis (LVP) at least 4 L within 2 days of randomization
Sepsis and/or uncontrolled bacterial infection
Less than 2 days anti-infective therapy for documented or suspected infection
Shock
Being treatment with or exposure to nephrotoxic agents, nonsteroidal anti-inflammatory drugs, or significant radiographic contrast agents (within the last 4 weeks)
Estimated life expectancy of less than 3 days
Superimposed acute liver injury due to drugs, dietary supplements, herbal preparations, viral hepatitis, or toxins, with the exception of acute alcoholic hepatitis
Proteinuria greater than 500 mg/day
Evidence of obstructive uropathy or parenchymal renal disease on ultrasound or other imaging
Tubular epithelial casts, heme granular casts, hematuria or microhematuria (greater than 50 red blood cells per high power field in the absence of recent catheterization) on urinalysis
Pregnancy; all women of child-bearing age and potential must have a negative pregnancy test
Cardiovascular disease judged by the investigator to be severe
Current or recent renal replacement therapy (RRT) within the past 4 weeks
Participation in other clinical research involving investigational medicinal products within 30 days of randomization
Transjugular intrahepatic portosystemic shunt (TIPS) within 30 days of randomization
Use of vasopressors for at least 3 consecutive days within the 14-day screening period - patients receiving any vasopressor other than midodrine and octreotide within 24 hours of qualifying SCr are also excluded, ie, a 24-hour washout is required prior to enrollment
Known allergy or sensitivity to terlipressin or another component of the study treatment
