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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:July 13, 2016
End Date:November 2019
Contact:Lisa Fitzgerald
Email:clinicaltrials@mnk.com
Phone:800-556-3314

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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)

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.

Inclusion Criteria:

- Written informed consent by subject or legally authorized representative.

- At least 18 years of age.

- 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.

Exclusion Criteria:

- 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 (eg, persisting bacteremia, persisting
ascitic fluid leucocytosis, fever, increasing leucocytosis with vasomotor
instability).

- Less than 2 days anti-infective therapy for documented or suspected infection.

- Shock.

- Current or recent (within 4 weeks) treatment with or exposure to nephrotoxic agents:
eg, aminoglycosides, amphotericin, cyclosporine A, cisplatin, nonsteroidal
anti-inflammatory drugs (NSAIDs: eg, ibuprofen, naproxen, diclofenac), significant
exposure to radiographic contrast agents (large doses or multiple injections of
iodinated contrast media; eg, during coronary or abdominal angiogram).

- Estimated life expectancy of less than 3 days.

- Superimposed acute liver injury due to drugs (eg, acetaminophen), dietary supplements,
herbal preparations, viral hepatitis, or toxins (eg, Amanita toxin with mushroom
poisoning carbon tetrachloride), 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.

Note: Urine sediment examination is required to exclude presence of heme granular casts and
other clinically significant casts.

- Subjects known to be pregnant; all women of child-bearing age and potential must have
a negative pregnancy test.

- Severe cardiovascular disease, including, but not limited to, unstable angina,
pulmonary edema, congestive heart failure requiring increasing doses of drug therapy,
or persisting symptomatic peripheral vascular disease, myocardial infarction or stable
chronic angina within the past 12 months, or any other cardiovascular disease judged
by the investigator to be severe.

- Current or recent (within 4 weeks) renal replacement therapy (RRT).

- 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 (eg, norepinephrine, epinephrine or vasopressin dopamine or other
vasopressors ) of at least 3 consecutive days within the 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.
We found this trial at
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Valhalla, New York 10595
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1720 2nd Ave S
Birmingham, Alabama 35233
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330 Brookline Ave
Boston, Massachusetts 02215
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3550 Jerome Avenue
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
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Miami, Florida 33124
(305) 284-2211
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Minneapolis, Minnesota 55455
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1211 Medical Center Dr
Nashville, Tennessee 37232
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1 Gustave L Levy Pl # 271
New York, New York 10029
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3400 Spruce St
Philadelphia, Pennsylvania 19104
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201 Presidents Circle
Salt Lake City, Utah 84108
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4502 Medical Drive
San Antonio, Texas 78284
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Seattle, Washington 98104
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Ann Arbor, Michigan 48109
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Atlanta, Georgia 30309
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
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345 St Paul Pl
Baltimore, Maryland 21202
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303 East Superior Street
Chicago, Illinois 60611
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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10900 Euclid Avenue
Cleveland, Ohio 44106
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
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2201 Inwood Rd
Dallas, Texas 75235
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1400 8th Avenue
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80 Seymour St
Hartford, Connecticut 6102
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7200 Cambridge Street
Houston, Texas 77030
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
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4500 San Pablo Road South
Jacksonville, Florida 32224
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3901 Rainbow Blvd
Kansas City, Kansas 66160
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1520 San Pablo Street
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New Orleans, Louisiana 70121
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Oklahoma City, Oklahoma
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Emile St
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3301 Lancaster Avenue
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Philadelphia, Pennsylvania 19122
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5501 Old York Road
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Phoenix, Arizona 85006
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Phoenix, Arizona 85054
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Pittsburgh, Pennsylvania 15240
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Richmond, Virginia 23249
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Richmond, Virginia 23298
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221 1st Avenue Southwest
Rochester, Minnesota 55902
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Saint Louis, Missouri 63110
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Saint Louis, Missouri 63110
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8026 Floyd Curl Drive
San Antonio, Texas 78229
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
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Stanford, California 94305
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Tampa, Florida 33606
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Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Tom Boyer, MD
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Washington, District of Columbia 20007
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