Effects of Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:July 24, 2018
End Date:October 2021
Contact:Mireia Torres
Email:mireia.torres@grifols.com
Phone:+34 93 5712273

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Prevention of Mortality With Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites

This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label
clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20%
administration versus SMT alone in subjects with decompensated cirrhosis and ascites. The
study population will consist of subjects being discharged after hospitalization for acute
decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring
diuretic therapy) with or without acute-on-chronic liver failure (ACLF) at admission or
during hospitalization but without ACLF at discharge.


Inclusion Criteria:

- Subjects with diagnosis of liver cirrhosis and uncomplicated ascites according to the
ICA criteria

- Subjects being discharged after hospitalization for acute decompensation of liver
cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy)
with or without ACLF at admission or during hospitalization but without ACLF at
discharge

- Subjects with ongoing diuretic treatment with an anti-mineralocorticoid drug at a dose
of ≥100 mg/day and furosemide ≥40 mg/day independent of response to treatment

- In subjects with cirrhosis due to hepatitis B virus, decompensation must occur in the
setting of continuous (not <3 months) appropriate antiviral therapy

- In subjects with cirrhosis due to hepatitis C virus, only decompensated patients who
will not receive antiviral therapy during the study period will be included

- In subjects with cirrhosis due to autoimmune hepatitis, decompensation must occur in
the setting of continuous immunosuppressive therapy

Exclusion Criteria:

- Subjects with ongoing ACLF at discharge

- Subjects with ongoing or recent (within the last 30 days) hepatorenal syndrome (HRS),
infection, or bleeding complications

- Subjects with transjugular intrahepatic portosystemic shunt (TIPS) or other surgical
porto-caval shunts

- Subjects with an established diagnosis of refractory ascites as defined by ICA
criteria

- Subjects requiring ≥2 paracenteses during the previous 30 days

- Subjects receiving anti-platelet therapy or anti-coagulant therapy during the previous
30 days

- Subjects with ongoing endoscopic eradication of esophageal varices at discharge

- Subjects with hepatic encephalopathy grade III or IV

- Subjects with evidence of current locally advanced or metastatic malignancy. Subjects
with hepatocellular carcinoma within the Milan criteria, non-melanocytic skin cancer,
or controlled breast or prostate cancer can be included

- Subjects with chronic heart failure

- Subjects with severe (grade III or IV) pulmonary disease

- Subjects with serum creatinine >2.0 x upper limit of normal

- Subjects with organic nephropathy as defined by ICA criteria

- Subjects with sever psychiatric disorders

- Subjects with a known infection with human immunodeficiency virus (HIV) or have
clinical signs and symptoms consistent with current HIV infection

- Females who are pregnant, breastfeeding, or if of childbearing potential, unwilling to
practice a highly effective method of contraception throughout the study

- Subjects with previous liver transplantation

- Subjects with known or suspected hypersensitivity to albumin

- Subjects participating in another clinical study within 3 months prior to screening

- Subjects with active drug addiction
We found this trial at
13
sites
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Coronado, California 92118
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Coronado, CA
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4500 S. Lancaster Rd.
Dallas, Texas 75216
800-849-3597
Dallas VA Medical Center VA North Texas Health Care System (VANTHCS) is a progressive health...
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Edegem,
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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New York, New York 10065
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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Phoenix, Arizona 85054
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Richmond, Virginia 23249
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San Francisco, California 94143
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San Francisco, CA
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