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

Primary Purpose

Decompensated Cirrhosis and Ascites

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Albutein 20% Injectable Solution
Standard medical treatment
Sponsored by
Grifols Therapeutics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decompensated Cirrhosis and Ascites

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Southern California Research Center
  • University of Miami Hospital
  • Rutgers-New Jersey Medical School
  • University of Pennsylvania
  • University of Missouri Hospital
  • Dallas VA Medical Center
  • McGuire VA Medical Center
  • Université libre de Bruxelles
  • Antwerp University Hospital
  • UZ Leuven - Campus Gasthuisberg
  • University Clinical Centre of the Republic Srpska, Clinic for Internal Diseases, Department of gastroenterology, hepatology and toxicology with internal medicine
  • Dr. Abdulah Nakas General Hospital, Department of Internal Medicine, Department of Gastroenterohepatology
  • Zenica Cantonal Hospital, Department of Internal Medicine with hemodialysis, Department of Gastroenterology and hepatology
  • MHAT "Pazardzhik" Ltd
  • MHAT"Sv. Pantelymon"
  • MHAT " Hadzhi Dimitar" Ltd
  • MHAT Sliven to MMA Sofia
  • MHAT "Sveta Sofia"
  • UMHAT "Sveti Ivan Rilski"
  • UMHATEM "N.I.Pirogov"
  • First Private MHAT Vratsa
  • University Health Network - Toronto General Hospital
  • Hvidovre University Hospital
  • Hôpital Minjoz - CHU Besaçon
  • Hôpital Henri Mondor-Creteil
  • CHU de Nice - Hôpital l'Archet 2
  • CHRU de Strasbourg - Hôpital Hautepierre
  • Centre Hépato-Biliaire - Hôpital Universitaire Paul Brousse
  • Charité - Universitaetsmedizin Berlin
  • Universitätsklinikum Essen
  • Universitätsklinikum Frankfurt
  • Universitätsklinikum Jena
  • Magyar Honvédség Egészségügyi Központ Gasztroenterológiai Osztály
  • Semmelweis Egyetem I. sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika
  • Debreceni Egyetem Klinikai Központ Gasztroenterológiai Klinika
  • Markhot Ferenc Oktatókórház és Rendelőintézet
  • Albert Schweitzer Kórház
  • Azienda Ospedaliero-Universitaria di Bologna Policlinico - S.Orsola
  • ASST Grande Ospedale Metropolitano Niguarda
  • Azienda Ospedaliera di Padova
  • Oddział Gastroenterologii i Hepatologii Uniwersyteckie Centrum Kliniczne im. prof.K.Gibińskiego SUM w Katowicach
  • SP ZOZ Szpital Uniwersytecki w Krakowie, Zakład Endoskopii SIV 31Aug22
  • Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital Kliniczny im. Barlickiego
  • ID Clinic
  • Klinika Gastroenterologii i Hepatologii z Pododdziałem Chorób Wewnętrznych Kliniczny Szpital Wojewodzki nr 1
  • Centrum Badań Klinicznych
  • Samodzielny Publiczny Szpital im.Papieza Jana Pawla II
  • Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital Kliniczny im. Barlickiego
  • Klinika Chorób Wewnętrznych, Diabetologii i Farmakologii Klinicznej, Centralny Szpital Kliniczny
  • Clinical Hospital Center "Dr Dragisa Misovic-Dedinje", Clinic for Internal Medicine, Gastroenterology Department
  • Clinical Hospital Center Zvezdara, Clinic for Internal Diseases, Clinical Department for Gastroenterology and Hepatology
  • University Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
  • Clinical Hospital Center "Bezanijska Kosa", Clinic for Internal Medicine, Department for Gastroenterology and Hepatology
  • Military Medical Academy, Clinic for Gastroenterology and Hepatology
  • University Clinical Center Kragujevac, Clinic for Internal Medicine, Gastroenterohepatology Center
  • 'University Clinical Center Nis, Clinic for Gastroenterology and Hepatology
  • Institution: General Hospital Pančevo, Internal Diseases Department, Gastroenterology Section
  • 'Health Center Uzice, Internal Diseases Department, Gastroenterology Section
  • Hospital Universitari Vall d'Hebron
  • Hospital Clínic de Barcelona
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitario Ramón y Cajal
  • Hospital Puerta de Hierro Majadahonda
  • Hospital Marqués de Valdecilla
  • Hospital Universitario Politecnico La Fe
  • Royal Free NHS Foundation Trust Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standard Medical Treatment + Albutein 20%

Standard Medical Treatment

Arm Description

Standard Medical Treatment plus Albutein 20% administrations

The sites will follow the Standard Medical Treatment as per their Standard of Care.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Time to death through 3 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone
Time to death through 6 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone
Time to death through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone
Total number of paracenteses through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone
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

Full Information

First Posted
February 12, 2018
Last Updated
September 19, 2023
Sponsor
Grifols Therapeutics LLC
Collaborators
Instituto Grifols, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03451292
Brief Title
Effects of Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites
Acronym
PRECIOSA
Official Title
Prevention of Mortality With Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 24, 2018 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grifols Therapeutics LLC
Collaborators
Instituto Grifols, S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompensated Cirrhosis and Ascites

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Medical Treatment + Albutein 20%
Arm Type
Experimental
Arm Description
Standard Medical Treatment plus Albutein 20% administrations
Arm Title
Standard Medical Treatment
Arm Type
Active Comparator
Arm Description
The sites will follow the Standard Medical Treatment as per their Standard of Care.
Intervention Type
Drug
Intervention Name(s)
Albutein 20% Injectable Solution
Intervention Description
Within 96 hours after discharge and following randomization, subjects will receive the first Albutein 20% infusion at the dose of 1.5 g/kg body weight (maximum 100 grams per subject). Thereafter, subjects will receive Albutein 20% infusions at the dose of 1.5 g/kg body weight (maximum 100 grams per subject) every 10 ± 2 days for the rest of the study (up to a maximum of 12 months). Subjects in this treatment group will also receive SMT.
Intervention Type
Other
Intervention Name(s)
Standard medical treatment
Intervention Description
Subjects will receive SMT according to published guidelines for the management of decompensated cirrhosis.
Primary Outcome Measure Information:
Title
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
Time Frame
3 months
Title
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
Time Frame
6 months
Title
Time to death through 3 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone
Time Frame
3 months
Title
Time to death through 6 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone
Time Frame
6 months
Title
Time to death through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone
Time Frame
12 months
Title
Total number of paracenteses through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone
Time Frame
12 months
Title
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Rutgers-New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Missouri Hospital
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
65201
Country
United States
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Université libre de Bruxelles
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University Clinical Centre of the Republic Srpska, Clinic for Internal Diseases, Department of gastroenterology, hepatology and toxicology with internal medicine
City
Mostar
ZIP/Postal Code
88000
Country
Bosnia and Herzegovina
Facility Name
Dr. Abdulah Nakas General Hospital, Department of Internal Medicine, Department of Gastroenterohepatology
City
Sarajevo
Country
Bosnia and Herzegovina
Facility Name
Zenica Cantonal Hospital, Department of Internal Medicine with hemodialysis, Department of Gastroenterology and hepatology
City
Zenica
Country
Bosnia and Herzegovina
Facility Name
MHAT "Pazardzhik" Ltd
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
MHAT"Sv. Pantelymon"
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MHAT " Hadzhi Dimitar" Ltd
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
MHAT Sliven to MMA Sofia
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
MHAT "Sveta Sofia"
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
UMHAT "Sveti Ivan Rilski"
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
UMHATEM "N.I.Pirogov"
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
First Private MHAT Vratsa
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
University Health Network - Toronto General Hospital
City
Toronto
Country
Canada
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Hôpital Minjoz - CHU Besaçon
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
Hôpital Henri Mondor-Creteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU de Nice - Hôpital l'Archet 2
City
Nice
ZIP/Postal Code
CS 23079
Country
France
Facility Name
CHRU de Strasbourg - Hôpital Hautepierre
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Centre Hépato-Biliaire - Hôpital Universitaire Paul Brousse
City
Villejuif
ZIP/Postal Code
94804
Country
France
Facility Name
Charité - Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
7740
Country
Germany
Facility Name
Magyar Honvédség Egészségügyi Központ Gasztroenterológiai Osztály
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Semmelweis Egyetem I. sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ Gasztroenterológiai Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Markhot Ferenc Oktatókórház és Rendelőintézet
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Albert Schweitzer Kórház
City
Hatvan
ZIP/Postal Code
3000
Country
Hungary
Facility Name
Azienda Ospedaliero-Universitaria di Bologna Policlinico - S.Orsola
City
Bologna
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35131
Country
Italy
Facility Name
Oddział Gastroenterologii i Hepatologii Uniwersyteckie Centrum Kliniczne im. prof.K.Gibińskiego SUM w Katowicach
City
Katowice
ZIP/Postal Code
40-751
Country
Poland
Facility Name
SP ZOZ Szpital Uniwersytecki w Krakowie, Zakład Endoskopii SIV 31Aug22
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital Kliniczny im. Barlickiego
City
Lublin
ZIP/Postal Code
20954
Country
Poland
Facility Name
ID Clinic
City
Mysłowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Klinika Gastroenterologii i Hepatologii z Pododdziałem Chorób Wewnętrznych Kliniczny Szpital Wojewodzki nr 1
City
Rzeszów
Country
Poland
Facility Name
Centrum Badań Klinicznych
City
Wrocław
ZIP/Postal Code
51-162
Country
Poland
Facility Name
Samodzielny Publiczny Szpital im.Papieza Jana Pawla II
City
Zamość
ZIP/Postal Code
22-400
Country
Poland
Facility Name
Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital Kliniczny im. Barlickiego
City
Łódź
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Klinika Chorób Wewnętrznych, Diabetologii i Farmakologii Klinicznej, Centralny Szpital Kliniczny
City
Łódź
ZIP/Postal Code
92-216
Country
Poland
Facility Name
Clinical Hospital Center "Dr Dragisa Misovic-Dedinje", Clinic for Internal Medicine, Gastroenterology Department
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Zvezdara, Clinic for Internal Diseases, Clinical Department for Gastroenterology and Hepatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center "Bezanijska Kosa", Clinic for Internal Medicine, Department for Gastroenterology and Hepatology
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Military Medical Academy, Clinic for Gastroenterology and Hepatology
City
Belgrad
ZIP/Postal Code
11040
Country
Serbia
Facility Name
University Clinical Center Kragujevac, Clinic for Internal Medicine, Gastroenterohepatology Center
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
'University Clinical Center Nis, Clinic for Gastroenterology and Hepatology
City
Niš
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Institution: General Hospital Pančevo, Internal Diseases Department, Gastroenterology Section
City
Pančevo
ZIP/Postal Code
26101
Country
Serbia
Facility Name
'Health Center Uzice, Internal Diseases Department, Gastroenterology Section
City
Užice
ZIP/Postal Code
31000
Country
Serbia
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Puerta de Hierro Majadahonda
City
Majadahonda
Country
Spain
Facility Name
Hospital Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Politecnico La Fe
City
Valencia
Country
Spain
Facility Name
Royal Free NHS Foundation Trust Hospital
City
London
State/Province
Londong
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30905652
Citation
Fernandez J, Claria J, Amoros A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Guell M, Nunez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Arbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Banares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos Garcia-Pagan J, Pavesi M, Jalan R, Bernardi M, Moreau R, Paez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22.
Results Reference
derived

Learn more about this trial

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

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