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A Study To Confirm Efficacy and Safety of Terlipressin in HRS Type 1

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Mallinckrodt
Information provided by (Responsible Party):
Mallinckrodt Identifier:
First received: May 10, 2016
Last updated: November 3, 2016
Last verified: November 2016

May 10, 2016
November 3, 2016
May 2016
January 2020   (Final data collection date for primary outcome measure)
Verified HRS Reversal [ Time Frame: Up to 14 Days ]
Defined as the percentage of subjects with 2 consecutive SCr values ≤1.5 mg/dL at least 2 hours apart.
Same as current
Complete list of historical versions of study NCT02770716 on Archive Site
  • Incidence of subjects with HRS reversal [ Time Frame: Up to 14 Days ]
    Incidence of subjects with HRS reversal, defined as the percentage of subjects with a SCr value ≤1.5 mg/dL by Day 14 or discharge.
  • Durability of HRS reversal [ Time Frame: Day 30 ]
    Percentage of subjects with HRS reversal without RRT to Day 30.
  • Incidence of HRS Reversal in the systemic inflammatory response syndrome (SIRS) [ Time Frame: Day 14 ]
Same as current
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A Study To Confirm Efficacy and Safety of Terlipressin in HRS Type 1
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)
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.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hepatorenal Syndrome
  • 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
  • Experimental: Terlipressin
    Lyophilized terlipressin acetate, IV, 1 mg by bolus injection q 6 hours
    Intervention: Drug: Terlipressin acetate
  • Placebo Comparator: Placebo Comparator
    Placebo, IV, 1 mg by bolus injection q 6 hours
    Intervention: Other: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2020
January 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults with cirrhosis and ascites
  • Rapidly progressive worsening in renal function to a serum creatinine (SCr) ≥2.25 mg/dL
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact: Kelly R Williams, BS 3146543277
United States
Not Provided
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Study Director: Khurram Jamil, MD Mallinckrodt
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP