A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 W… (NCT01143246) | Clinical Trial Compass
CompletedPhase 3
A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin
United States196 participantsStarted 2010-10-11
Plain-language summary
This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent by subject or legally authorized representative
✓. At least 18 years of age
✓. Cirrhosis and ascites
✓. Rapidly progressive reduction in renal function characterized by:
✓. No sustained improvement in renal function (\< 20% decrease in SCr and SCr ≥ 2.25 mg/dL) 48 hours after both diuretic withdrawal and the beginning of plasma volume expansion with albumin:
Exclusion criteria
✕. SCr \> 7 mg/dL
✕. Shock Note: Hypotension (Mean Arterial Pressure \< 70 mm Hg or a decrease \> 40 mm Hg in systolic blood pressure from baseline) with evidence of hypoperfusion abnormalities despite adequate fluid resuscitation.
✕. Sepsis or systemic inflammatory response syndrome (SIRS)
✕. \< 2 days anti-infective therapy for documented or suspected infection
✕. Proteinuria \> 500 mg/day
✕. Hematuria or microhematuria (\> 50 red blood cells per high power field)
✕. Clinically significant casts on urinalysis, including granular casts Note: Urine sediment examination is required to exclude presence of granular casts and other clinically significant casts \[e.g., red blood cell (RBC) casts\].
What they're measuring
1
Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal