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A Multi-Center, Randomized, Placebo Controlled, Double-Blind Study to Confirm Efficacy and Safety of Terlipressin in Subjects With Hepatorenal Syndrome Type 1 (The CONFIRM Study) (NCT02770716)

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This study is to confirm the efficacy and safety of intravenous terlipressin versus placebo in the treatment of adult subjects with hepatorenal syndrome (HRS) Type 1.
  • Drug: Terlipressin acetate
    Lyophilized terlipressin acetate, IV, 1 mg by bolus injection q 6 hours
    • Other: Placebo Comparator
      11 mg mannitol reconstituted with 5 ml of sterile 0.9% sodium chloride solution
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • Adults with cirrhosis and ascites
      • Rapidly progressive worsening in renal function to a serum creatinine (SCr) ≥2.25 mg/dL and meeting a trajectory for SCr to double over 2 weeks
      • No sustained improvement in renal function (<20% decrease in SCr and SCr ≥2.25 mg/dL) at least 48 hours after diuretic withdrawal and the beginning of plasma volume expansion with albumin
      Exclusion Criteria:
      • Serum creatinine level >7.0 mg/dL
      • At least 1 event of large volume paracentesis (LVP) ≥4 L within 2 days of randomization
      • Sepsis and/or uncontrolled bacterial infection
      • <2 days anti-infective therapy for documented or suspected infection
      • Shock
      • Current or recent (within 4 weeks) treatment with or exposure to nephrotoxic agents
      • Superimposed acute liver injury due to drugs (e.g., acetaminophen), dietary supplements, herbal preparations, viral hepatitis, or toxins
      • Proteinuria >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
      • Confirmed pregnancy
      • Severe cardiovascular disease, including, but not limited to, unstable angina, pulmonary edema, congestive heart failure
      • Current or recent (within 4 weeks) renal replacement therapy (RRT)
      • Participation in other clinical research involving investigational medicinal products within 30 days of randomization
      • Estimated life expectancy of less than 3 days.
      • TIPS within 30 days of randomization.
      • Use of vasopressors (eg, norepinephrine, epinephrine or vasopressin, dopamine or other vasopressors) of at least 3 consecutive days within prior 14-day screening period. Patients receiving a vasopressor other than midodrine within 24 hours of qualifying SCr are excluded, ie, a 24-h washout is required prior to enrollment. Note: Patients receiving midodrine and octreotide may be enrolled. Midodrine and octreotide treatment must be stopped prior to randomization.
      • Known allergy or sensitivity to terlipressin or another component of the study treatment.
      This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter pivotal trial of terlipressin in subjects with HRS type 1. HRS is a rare syndrome of marked renal dysfunction in patients with cirrhosis, decompensated liver disease, and portal hypertension. HRS type 1 is characterized by a rapid progressive renal impairment and has a very poor prognosis with >80% mortality within 3 months. At present, there are no approved drug therapies for HRS type 1 in the US or Canada. The only curative treatment for HRS type 1 and the underlying end-stage cirrhosis is liver transplantation. However, many patients will not survive long enough to receive a liver transplant. Increased understanding of the pathophysiology of HRS type 1 has demonstrated that vasoconstrictive drug therapy may reverse HRS type 1. Substantial data available from many published clinical investigations in the literature provide compelling evidence suggesting that administration of terlipressin improves renal function in patients with HRS. A total of 300 subjects are planned to be enrolled at approximately 70 sites in the US and Canada. An interim analysis is scheduled after 150 subjects are enrolled. The study will be stopped if the pre-specified threshold for efficacy criteria is met at interim analysis.

      59 locations

      Status:
      recruiting
      Type:
      Interventional
      Phase:
      Start:
      12 July, 2016
      Updated:
      19 March, 2018
      Participants:
      300
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