Effects of Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites
- Conditions
- Decompensated Cirrhosis and Ascites
- Interventions
- Other: Standard medical treatmentDrug: Albutein 20% Injectable Solution
- Registration Number
- NCT03451292
- Lead Sponsor
- Grifols Therapeutics LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 410
- Male or female subject ≥18 years of age.
- Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).
- Subjects who have been hospitalized 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 Screening.
- In subjects with cirrhosis due to hepatitis B virus, decompensation must occur in the setting of continuous (no less than 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 (Subjects receiving antiviral therapy within 14 days prior to enrollment cannot be included in the study).
- In subjects with cirrhosis due to autoimmune hepatitis, decompensation must occur in the setting of continuous immunosuppressive therapy.
- Subjects must be willing and able to provide written informed consent or have an authorized representative able to provide written informed consent on behalf of the subject in accordance with local law and institutional policy.
- CLIF-C AD score > 50 points at screening.
- Subjects with ACLF at Screening
- Subjects with type 1 HRS currently on treatment with vasoconstrictors or hemodialysis.
- Subjects with TIPS or other surgical porto-caval shunts.
- Subjects with refractory ascites as defined by ICA criteria without any other event of acute decompensation.
- Subjects receiving dual anti-platelet therapy or anti-coagulant therapy (exception: DVT prophylaxis).
- Subjects with ongoing endoscopic eradication of esophageal varices with ≤ 2 endoscopic sessions completed before screening.
- Subjects with evidence of current locally advanced or metastatic malignancy.
- Subjects with acute or chronic heart failure (New York Heart Association [NYHA]).
- Subjects with severe (grade III or IV) pulmonary disease (Global Obstructive Lung Disease [GOLD]).
- Subjects with nephropathy with renal failure with serum creatinine >2 mg/dL or systemic hypertension.
- Subjects with severe 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 effective methods of contraception
- 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 (exceptions: active alcoholism or marijuana).
- In the opinion of the investigator, the subject may have compliance problems with the protocol and the procedures of the protocol.
- Subjects with ongoing or recent variceal bleeding (subjects can be included 2 weeks after hemorrhagic episode).
- Subjects with septic shock at screening.
- Subjects with ongoing SBP infection (subjects can be included upon resolution).
- Subjects with current infection of COVID19, those who are less than 14 days post recovery, or those who have clinical signs and symptoms consistent with COVID19 infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Medical Treatment Standard medical treatment The sites will follow the Standard Medical Treatment as per their Standard of Care. Standard Medical Treatment + Albutein 20% Albutein 20% Injectable Solution Standard Medical Treatment plus Albutein 20% administrations Standard Medical Treatment + Albutein 20% Standard medical treatment Standard Medical Treatment plus Albutein 20% administrations
- Primary Outcome Measures
Name Time Method Time to liver transplantation or death (whichever comes first) through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone 12 months
- Secondary Outcome Measures
Name Time Method Time to liver transplantation or death (whichever comes first) through 3 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone 3 months Time to liver transplantation or death (whichever comes first) through 6 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone 6 months Time to death through 3 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone 3 months Total number of paracenteses through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone 12 months Time to death through 6 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone 6 months Time to death through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone 12 months Total number of incidences of refractory ascites according to the International Club of Ascites (ICA) through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone 12 months
Trial Locations
- Locations (65)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Missouri Hospital
🇺🇸Columbia, South Carolina, United States
Southern California Research Center
🇺🇸Coronado, California, United States
University of Miami Hospital
🇺🇸Miami, Florida, United States
Rutgers-New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Antwerp University Hospital
🇧🇪Edegem, Belgium
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
UZ Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
MHAT"Sv. Pantelymon"
🇧🇬Plovdiv, Bulgaria
MHAT "Pazardzhik" Ltd
🇧🇬Pazardzhik, Bulgaria
MHAT "Sveta Sofia"
🇧🇬Sofia, Bulgaria
MHAT Sliven to MMA Sofia
🇧🇬Sliven, Bulgaria
UMHAT "Sveti Ivan Rilski"
🇧🇬Sofia, Bulgaria
UMHATEM "N.I.Pirogov"
🇧🇬Sofia, Bulgaria
First Private MHAT Vratsa
🇧🇬Vratsa, Bulgaria
University Health Network - Toronto General Hospital
🇨🇦Toronto, Canada
Hvidovre University Hospital
🇩🇰Hvidovre, Denmark
CHU de Nice - Hôpital l'Archet 2
🇫🇷Nice, France
CHRU de Strasbourg - Hôpital Hautepierre
🇫🇷Strasbourg, France
Centre Hépato-Biliaire - Hôpital Universitaire Paul Brousse
🇫🇷Villejuif, France
Charité - Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany
Semmelweis Egyetem I. sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika
🇭🇺Budapest, Hungary
Magyar Honvédség Egészségügyi Központ Gasztroenterológiai Osztály
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Központ Gasztroenterológiai Klinika
🇭🇺Debrecen, Hungary
Markhot Ferenc Oktatókórház és Rendelőintézet
🇭🇺Eger, Hungary
Albert Schweitzer Kórház
🇭🇺Hatvan, Hungary
Azienda Ospedaliero-Universitaria di Bologna Policlinico - S.Orsola
🇮🇹Bologna, Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Oddział Gastroenterologii i Hepatologii Uniwersyteckie Centrum Kliniczne im. prof.K.Gibińskiego SUM w Katowicach
🇵🇱Katowice, Poland
ID Clinic
🇵🇱Mysłowice, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie, Zakład Endoskopii SIV 31Aug22
🇵🇱Kraków, Poland
Klinika Gastroenterologii i Hepatologii z Pododdziałem Chorób Wewnętrznych Kliniczny Szpital Wojewodzki nr 1
🇵🇱Rzeszów, Poland
Samodzielny Publiczny Szpital im.Papieza Jana Pawla II
🇵🇱Zamość, Poland
Centrum Badań Klinicznych
🇵🇱Wrocław, Poland
Klinika Chorób Wewnętrznych, Diabetologii i Farmakologii Klinicznej, Centralny Szpital Kliniczny
🇵🇱Łódź, Poland
'University Clinical Center Nis, Clinic for Gastroenterology and Hepatology
🇷🇸Niš, Serbia
Clinical Hospital Center "Dr Dragisa Misovic-Dedinje", Clinic for Internal Medicine, Gastroenterology Department
🇷🇸Belgrade, Serbia
Clinical Hospital Center Zvezdara, Clinic for Internal Diseases, Clinical Department for Gastroenterology and Hepatology
🇷🇸Belgrade, Serbia
University Clinical Center Kragujevac, Clinic for Internal Medicine, Gastroenterohepatology Center
🇷🇸Kragujevac, Serbia
Military Medical Academy, Clinic for Gastroenterology and Hepatology
🇷🇸Belgrad, Serbia
'Health Center Uzice, Internal Diseases Department, Gastroenterology Section
🇷🇸Užice, Serbia
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Institution: General Hospital Pančevo, Internal Diseases Department, Gastroenterology Section
🇷🇸Pančevo, Serbia
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Politecnico La Fe
🇪🇸Valencia, Spain
Hospital Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Spain
Royal Free NHS Foundation Trust Hospital
🇬🇧London, Londong, United Kingdom
University Clinical Centre of the Republic Srpska, Clinic for Internal Diseases, Department of gastroenterology, hepatology and toxicology with internal medicine
🇧🇦Mostar, Bosnia and Herzegovina
MHAT " Hadzhi Dimitar" Ltd
🇧🇬Sliven, Bulgaria
Hôpital Minjoz - CHU Besaçon
🇫🇷Besançon, France
Hôpital Henri Mondor-Creteil
🇫🇷Créteil, France
Universitätsklinikum Essen
🇩🇪Essen, Germany
Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital Kliniczny im. Barlickiego
🇵🇱Łódź, Poland
Hospital Marqués de Valdecilla
🇪🇸Santander, Spain
Zenica Cantonal Hospital, Department of Internal Medicine with hemodialysis, Department of Gastroenterology and hepatology
🇧🇦Zenica, Bosnia and Herzegovina
University Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
🇷🇸Belgrade, Serbia
Dr. Abdulah Nakas General Hospital, Department of Internal Medicine, Department of Gastroenterohepatology
🇧🇦Sarajevo, Bosnia and Herzegovina
Clinical Hospital Center "Bezanijska Kosa", Clinic for Internal Medicine, Department for Gastroenterology and Hepatology
🇷🇸Belgrade, Serbia
Université libre de Bruxelles
🇧🇪Bruxelles, Belgium