CClinicalTrials.gg
Sign In
CompletedNCT03451292PRECIOSAUpdated Jun 6, 2025Results posted

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

A Phase 3 interventional study of Albutein 20% and SMT in Decompensated Cirrhosis and Ascites, sponsored by Grifols Therapeutics LLC. Completed at 66 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.

Sponsored by Grifols Therapeutics LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
410
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 participants with decompensated cirrhosis and ascites. The study population will consist of participants 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.

02

Conditions studied

  • Decompensated Cirrhosis and Ascites
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female participants ≥18 years of age.
  • Participants with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).
  • Participants 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 participants with cirrhosis due to hepatitis B virus, decompensation must occur in the setting of continuous (no less than 3 months) appropriate antiviral therapy.
  • In participants with cirrhosis due to hepatitis C virus, only decompensated participants who will not receive antiviral therapy during the study period will be included (Participants receiving antiviral therapy within 14 days prior to enrollment cannot be included in the study).
  • In participants with cirrhosis due to autoimmune hepatitis, decompensation must occur in the setting of continuous immunosuppressive therapy.
  • Participants 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 participant in accordance with local law and institutional policy.
  • Chronic liver failure-consortium acute decompensation (CLIF-C AD) score > 50 points at screening.

Exclusion criteria

Exclusion Criteria:

  • Participants with ACLF at Screening
  • Participants with type 1 hepatorenal syndrome (HRS) currently on treatment with vasoconstrictors or hemodialysis.
  • Participants with transjugular intrahepatic portosystemic shunt (TIPS) or other surgical porto-caval shunts.
  • Participants with refractory ascites as defined by the International Club of Ascites (ICA) criteria without any other event of acute decompensation.
  • Participants receiving dual anti-platelet therapy or anti-coagulant therapy (exception: deep vein thrombosis (DVT) prophylaxis).
  • Participants with ongoing endoscopic eradication of esophageal varices with ≤ 2 endoscopic sessions completed before screening.
  • Participants with evidence of current locally advanced or metastatic malignancy.
  • Participants with acute or chronic heart failure (New York Heart Association [NYHA]).
  • Participants with severe (grade III or IV) pulmonary disease (Global Obstructive Lung Disease [GOLD]).
  • Participants with nephropathy with renal failure with serum creatinine >2 milligrams/deciliters (mg/dL) or systemic hypertension.
  • Participants with severe psychiatric disorders.
  • Participants 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
  • Participants with previous liver transplantation.
  • Participants with known or suspected hypersensitivity to albumin.
  • Participants participating in another clinical study within 3 months prior to screening.
  • Participants with active drug addiction (exceptions: active alcoholism or marijuana).
  • In the opinion of the investigator, the participants may have compliance problems with the protocol and the procedures of the protocol.
  • Participants with ongoing or recent variceal bleeding (participants can be included 2 weeks after hemorrhagic episode).
  • Participants with septic shock at screening.
  • Participants with ongoing spontaneous bacterial peritonitis (SBP) infection (participants can be included upon resolution).
  • Participants with current infection of coronavirus disease of 2019 (COVID19), those who are less than 14 days post recovery, or those who have clinical signs and symptoms consistent with COVID19 infection.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
410 participants (actual)

Study arms

  • Experimental
    SMT + Albutein 20%

    Participants received Albutein 20%, at a dose of 1.5 grams/kilograms (g/kg), based on their body weight (maximum 100 grams per participant), as an intravenous (IV) infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with standard medical treatment (SMT) administered as per institution standards for the management of decompensated cirrhosis up to 12 months.

    Drug: Albutein 20% · Other: SMT

  • Active comparator
    SMT

    Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.

    Other: SMT

Interventions

  • DrugAlbutein 20%

    Injectable solution

  • OtherSMT

    Participants received SMT according to institution standards for the management of decompensated cirrhosis.

05

What researchers measure

Primary outcomes

  1. Time to Liver Transplantation or Death Through 1 Year After Randomization: Percentage of Participants With an Event

    Time to one-year transplant-free survival was calculated as earlier of \[(date of liver transplantation or date of death) - randomization date + 1\] for participants who died or had liver transplant within the analysis period of 361 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 361, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as \[(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)\].

    Time frame: Up to Day 361

Secondary outcomes

  1. Time to Liver Transplantation or Death Through 3 Months After Randomization: Percentage of Participants With an Event

    Time to 3-months transplant-free survival was calculated as earlier of \[(date of liver transplantation or date of death) - randomization date + 1\] for participants who died or had liver transplant within the analysis period of 91 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 91, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as \[(participants with an event up to the analysis cut-off Day 91) / (number of participants in the ITT group)\].

    Time frame: Up to Day 91

  2. Time to Liver Transplantation or Death Through 6 Months After Randomization: Percentage of Participants With an Event

    Time to 6-months transplant-free survival was calculated as earlier of \[(date of liver transplantation or date of death) - randomization date + 1\] for participants who died or had liver transplant within the analysis period of 181 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 181, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as \[(participants with an event up to the analysis cut-off Day 181) / (number of participants in the ITT group)\].

    Time frame: Up to Day 181

  3. Time to Death Through 3 Months After Randomization: Percentage of Participants With an Event

    Time to 3-months survival was calculated as the earlier of \[(date of death) - randomization date + 1\] for those participants who died within the analysis period of 91 days. Participants who did not die within the analysis period were censored at the earlier of the date of last contact or analysis cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on death, these events if reported before the analysis cut-off Day 91 of this endpoint, were considered. The percentage of participants with events (death) without censoring participants who underwent liver transplantation within the analysis period were reported. The percentage of participants was calculated as \[(participants with an event up to the analysis cut-off Day 91) / (number of participants in the ITT group)\].

    Time frame: Up to Day 91

  4. Time to Death Through 6 Months After Randomization: Percentage of Participants With an Event

    Time to 6-months survival was calculated as the earlier of \[(date of death) - randomization date + 1\] for those participants who died within the analysis period of 181 days. Participants who did not die within the analysis period were censored at the earlier of the date of last contact or analysis cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on death, these events if reported before the analysis cut-off Day 181 of this endpoint, were considered. The percentage of participants with events (death) without censoring participants who underwent liver transplantation within the analysis period were reported. The percentage of participants was calculated as \[(participants with an event up to the analysis cut-off Day 181) / (number of participants in the ITT group)\].

    Time frame: Up to Day 181

  5. Time to Death Through 1 Year After Randomization: Percentage of Participants With an Event

    Time to 1 year survival was calculated as the earlier of \[(date of death) - randomization date + 1\] for those participants who died within the analysis period of 361 days. Participants who did not die within the analysis period were censored at the earlier of the date of last contact or analysis cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on death, these events if reported before the analysis cut-off Day 361 of this endpoint, were considered. The percentage of participants with events (death) without censoring participants who underwent liver transplantation within the analysis period were reported. The percentage of participants was calculated as \[(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)\].

    Time frame: Up to Day 361

  6. Total Number of Paracenteses Through 1 Year After Randomization

    Paracenteses is a medical procedure used to remove excess fluid from the abdominal cavity. For each participant, the total number of reported paracenteses on treatment was calculated. Number of paracenteses per participant while on treatment was reported.

    Time frame: Up to Day 361

  7. Number of Participants With Refractory Ascites According to the International Club of Ascites (ICA) Through 1 Year After Randomization

    Refractory Ascites was defined as ascites that cannot be mobilized, or the early recurrence of which cannot be prevented because of a lack of response to sodium restriction and diuretic, or the development of diuretic-induced complications that preclude the use of an effective diuretic dosage treatment. Incidence of refractory ascites occurring on treatment was defined as any incidence that occurred with a start date/time on or after the participants date/time of randomization (for SMT Alone group) or commencement of Albutein (SMT+ Albutein 20% group) treatment.

    Time frame: Up to Day 361

06

Results

Posted Jun 6, 2025

Participant flow

A total of 410 participants took part in the study at 40 investigative sites across 14 countries in Europe and the United States from 24 July 2018 to 21 May 2024.

Participant flow — Overall Study
MilestoneSMT + Albutein 20%SMT Alone
Started203207
Completed110105
Not completed93102
Withdrew: Death4459
Withdrew: Withdrawal by subject1813
Withdrew: Transplantation1812
Withdrew: Lost to follow-up412
Withdrew: Physician decision43
Withdrew: Adverse event33
Withdrew: Non-compliance with study drug20

Outcome measures

PrimaryTime to Liver Transplantation or Death Through 1 Year After Randomization: Percentage of Participants With an Event

Time to one-year transplant-free survival was calculated as earlier of \[(date of liver transplantation or date of death) - randomization date + 1\] for participants who died or had liver transplant within the analysis period of 361 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 361, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as \[(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)\].

Time frame:
Up to Day 361
Reported as:
Number · percentage of participants
Time to Liver Transplantation or Death Through 1 Year After Randomization: Percentage of Participants With an Event
percentage of participantsSMT + Albutein 20%SMT Alone
Time to Liver Transplantation or Death Through 1 Year After Randomization: Percentage of Participants With an Event33.538.6
Statistical analysis
  • SMT + Albutein 20% vs SMT Alone · Cox Proportional- Hazards (PH) model · p = 0.17 · Hazard ratio (hr): 0.80 · 95% CI 0.58 to 1.10
SecondaryTime to Liver Transplantation or Death Through 3 Months After Randomization: Percentage of Participants With an Event

Time to 3-months transplant-free survival was calculated as earlier of \[(date of liver transplantation or date of death) - randomization date + 1\] for participants who died or had liver transplant within the analysis period of 91 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 91, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as \[(participants with an event up to the analysis cut-off Day 91) / (number of participants in the ITT group)\].

Time frame:
Up to Day 91
Reported as:
Number · percentage of participants
Time to Liver Transplantation or Death Through 3 Months After Randomization: Percentage of Participants With an Event
percentage of participantsSMT + Albutein 20%SMT Alone
Time to Liver Transplantation or Death Through 3 Months After Randomization: Percentage of Participants With an Event10.817.9
SecondaryTime to Liver Transplantation or Death Through 6 Months After Randomization: Percentage of Participants With an Event

Time to 6-months transplant-free survival was calculated as earlier of \[(date of liver transplantation or date of death) - randomization date + 1\] for participants who died or had liver transplant within the analysis period of 181 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 181, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as \[(participants with an event up to the analysis cut-off Day 181) / (number of participants in the ITT group)\].

Time frame:
Up to Day 181
Reported as:
Number · percentage of participants
Time to Liver Transplantation or Death Through 6 Months After Randomization: Percentage of Participants With an Event
percentage of participantsSMT + Albutein 20%SMT Alone
Time to Liver Transplantation or Death Through 6 Months After Randomization: Percentage of Participants With an Event22.728.5
SecondaryTime to Death Through 3 Months After Randomization: Percentage of Participants With an Event

Time to 3-months survival was calculated as the earlier of \[(date of death) - randomization date + 1\] for those participants who died within the analysis period of 91 days. Participants who did not die within the analysis period were censored at the earlier of the date of last contact or analysis cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on death, these events if reported before the analysis cut-off Day 91 of this endpoint, were considered. The percentage of participants with events (death) without censoring participants who underwent liver transplantation within the analysis period were reported. The percentage of participants was calculated as \[(participants with an event up to the analysis cut-off Day 91) / (number of participants in the ITT group)\].

Time frame:
Up to Day 91
Reported as:
Number · percentage of participants
Time to Death Through 3 Months After Randomization: Percentage of Participants With an Event
percentage of participantsSMT + Albutein 20%SMT Alone
Time to Death Through 3 Months After Randomization: Percentage of Participants With an Event9.414.0
SecondaryTime to Death Through 6 Months After Randomization: Percentage of Participants With an Event

Time to 6-months survival was calculated as the earlier of \[(date of death) - randomization date + 1\] for those participants who died within the analysis period of 181 days. Participants who did not die within the analysis period were censored at the earlier of the date of last contact or analysis cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on death, these events if reported before the analysis cut-off Day 181 of this endpoint, were considered. The percentage of participants with events (death) without censoring participants who underwent liver transplantation within the analysis period were reported. The percentage of participants was calculated as \[(participants with an event up to the analysis cut-off Day 181) / (number of participants in the ITT group)\].

Time frame:
Up to Day 181
Reported as:
Number · percentage of participants
Time to Death Through 6 Months After Randomization: Percentage of Participants With an Event
percentage of participantsSMT + Albutein 20%SMT Alone
Time to Death Through 6 Months After Randomization: Percentage of Participants With an Event16.723.2
SecondaryTime to Death Through 1 Year After Randomization: Percentage of Participants With an Event

Time to 1 year survival was calculated as the earlier of \[(date of death) - randomization date + 1\] for those participants who died within the analysis period of 361 days. Participants who did not die within the analysis period were censored at the earlier of the date of last contact or analysis cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on death, these events if reported before the analysis cut-off Day 361 of this endpoint, were considered. The percentage of participants with events (death) without censoring participants who underwent liver transplantation within the analysis period were reported. The percentage of participants was calculated as \[(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)\].

Time frame:
Up to Day 361
Reported as:
Number · percentage of participants
Time to Death Through 1 Year After Randomization: Percentage of Participants With an Event
percentage of participantsSMT + Albutein 20%SMT Alone
Time to Death Through 1 Year After Randomization: Percentage of Participants With an Event26.131.9
SecondaryTotal Number of Paracenteses Through 1 Year After Randomization

Paracenteses is a medical procedure used to remove excess fluid from the abdominal cavity. For each participant, the total number of reported paracenteses on treatment was calculated. Number of paracenteses per participant while on treatment was reported.

Time frame:
Up to Day 361
Reported as:
Mean · paracenteses per participant
Total Number of Paracenteses Through 1 Year After Randomization
paracenteses per participantSMT + Albutein 20%SMT Alone
Total Number of Paracenteses Through 1 Year After Randomization1.3 ± 3.582.3 ± 5.07
SecondaryNumber of Participants With Refractory Ascites According to the International Club of Ascites (ICA) Through 1 Year After Randomization

Refractory Ascites was defined as ascites that cannot be mobilized, or the early recurrence of which cannot be prevented because of a lack of response to sodium restriction and diuretic, or the development of diuretic-induced complications that preclude the use of an effective diuretic dosage treatment. Incidence of refractory ascites occurring on treatment was defined as any incidence that occurred with a start date/time on or after the participants date/time of randomization (for SMT Alone group) or commencement of Albutein (SMT+ Albutein 20% group) treatment.

Time frame:
Up to Day 361
Reported as:
Count of participants · Participants
Number of Participants With Refractory Ascites According to the International Club of Ascites (ICA) Through 1 Year After Randomization
ParticipantsSMT + Albutein 20%SMT Alone
Number of Participants With Refractory Ascites According to the International Club of Ascites (ICA) Through 1 Year After Randomization3346

Adverse events

Collected over Up to 12 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SMT + Albutein 20%53/203 (26.1%)52/203 (25.6%)51/203 (25.1%)
SMT Alone67/207 (32.4%)70/207 (33.8%)47/207 (22.7%)
Most frequent serious events
Showing 10 of 118
Most frequent serious events
EventSMT + Albutein 20%SMT Alone
Gastrointestinal haemorrhageGastrointestinal disorders11/2030/207
PneumoniaInfections and infestations2/2038/207
Urinary Tract InfectionInfections and infestations2/2037/207
DeathGeneral disorders5/2034/207
SepsisInfections and infestations2/2035/207
Respiratory failureRespiratory, thoracic and mediastinal disorders1/2035/207
Septic ShockInfections and infestations1/2034/207
Incarcerated umbilical herniaGastrointestinal disorders0/2034/207
Clostridium Difficile InfectionInfections and infestations0/2033/207
EpilepsyNervous system disorders1/2033/207
Most frequent other events
Most frequent other events
EventSMT + Albutein 20%SMT Alone
AnaemiaBlood and lymphatic system disorders14/20317/207
Urinary tract infectionInfections and infestations13/20315/207
PruritusSkin and subcutaneous tissue disorders12/2032/207
HyperkalaemiaMetabolism and nutrition disorders11/2038/207
DiarrhoeaGastrointestinal disorders11/2038/207
HypokalaemiaMetabolism and nutrition disorders7/20311/207

Baseline characteristics

Intent-to-treat (ITT) population included all participants who were randomized.

Age, Continuous
Age, Continuous(years)SMT + Albutein 20%SMT AloneTotal
Mean58.9 ± 10.0358.7 ± 10.3058.8 ± 10.16
Sex: Female, Male
Sex: Female, Male(Participants)SMT + Albutein 20%SMT AloneTotal
Female6255117
Male141152293
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SMT + Albutein 20%SMT AloneTotal
Hispanic or Latino181735
Not Hispanic or Latino185190375
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SMT + Albutein 20%SMT AloneTotal
American Indian or Alaska Native000
Asian314
Native Hawaiian or Other Pacific Islander000
Black or African American246
White197199396
More than one race011
Unknown or Not Reported123
07

Study locations

66 sites
  • Southern California Research Center
    Coronado, California 92118, United States
  • University of Miami Hospital
    Miami, Florida 33136, United States
  • Rutgers-New Jersey Medical School
    Newark, New Jersey 07103, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • University of Missouri Hospital
    Columbia, South Carolina 65201, United States
  • Dallas VA Medical Center
    Dallas, Texas 75216, United States
  • McGuire VA Medical Center
    Richmond, Virginia 23249, United States
  • Université libre de Bruxelles
    Bruxelles, 1070, Belgium
  • Antwerp University Hospital
    Edegem, 2650, Belgium
  • UZ Leuven - Campus Gasthuisberg
    Leuven, 3000, Belgium
  • University Clinical Centre of the Republic Srpska, Clinic for Internal Diseases, Department of gastroenterology, hepatology and toxicology with internal medicine
    Mostar, 88000, Bosnia and Herzegovina
  • Dr. Abdulah Nakas General Hospital, Department of Internal Medicine, Department of Gastroenterohepatology
    Sarajevo, Bosnia and Herzegovina
  • Zenica Cantonal Hospital, Department of Internal Medicine with hemodialysis, Department of Gastroenterology and hepatology
    Zenica, Bosnia and Herzegovina
  • MHAT "Pazardzhik" Ltd
    Pazardzhik, 4400, Bulgaria
  • MHAT"Sv. Pantelymon"
    Plovdiv, 4000, Bulgaria
  • MHAT " Hadzhi Dimitar" Ltd
    Sliven, 8800, Bulgaria
  • MHAT Sliven to MMA Sofia
    Sliven, 8800, Bulgaria
  • MHAT "Sveta Sofia"
    Sofia, 1000, Bulgaria
  • UMHAT "Sveti Ivan Rilski"
    Sofia, 1000, Bulgaria
  • UMHATEM "N.I.Pirogov"
    Sofia, 1000, Bulgaria
  • First Private MHAT Vratsa
    Vratsa, 3000, Bulgaria
  • University Health Network - Toronto General Hospital
    Toronto, Canada
  • Hvidovre University Hospital
    Hvidovre, 2650, Denmark
  • Hôpital Minjoz - CHU Besaçon
    Besançon, 25000, France
  • Hôpital Henri Mondor-Creteil
    Créteil, 94010, France
  • CHU de Nice - Hôpital l'Archet 2
    Nice, CS 23079, France
  • CHRU de Strasbourg - Hôpital Hautepierre
    Strasbourg, 67200, France
  • Centre Hépato-Biliaire - Hôpital Universitaire Paul Brousse
    Villejuif, 94804, France
  • Charité - Universitaetsmedizin Berlin
    Berlin, 13353, Germany
  • Universitätsklinikum Essen
    Essen, 45147, Germany
  • Universitätsklinikum Frankfurt
    Frankfurt, 60590, Germany
  • Universitätsklinikum Jena
    Jena, 7740, Germany
  • Magyar Honvédség Egészségügyi Központ Gasztroenterológiai Osztály
    Budapest, 1062, Hungary
  • Semmelweis Egyetem I. sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika
    Budapest, 1082, Hungary
  • Debreceni Egyetem Klinikai Központ Gasztroenterológiai Klinika
    Debrecen, 4032, Hungary
  • Markhot Ferenc Oktatókórház és Rendelőintézet
    Eger, 3300, Hungary
  • Albert Schweitzer Kórház
    Hatvan, 3000, Hungary
  • Azienda Ospedaliero-Universitaria di Bologna Policlinico - S.Orsola
    Bologna, Italy
  • ASST Grande Ospedale Metropolitano Niguarda
    Milano, 20162, Italy
  • Azienda Ospedaliera di Padova
    Padova, 35131, Italy
  • Oddział Gastroenterologii i Hepatologii Uniwersyteckie Centrum Kliniczne im. prof.K.Gibińskiego SUM w Katowicach
    Katowice, 40-751, Poland
  • SP ZOZ Szpital Uniwersytecki w Krakowie, Zakład Endoskopii SIV 31Aug22
    Kraków, 30-688, Poland
  • Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital Kliniczny im. Barlickiego
    Lublin, 20954, Poland
  • ID Clinic
    Mysłowice, 41-400, Poland
  • Klinika Gastroenterologii i Hepatologii z Pododdziałem Chorób Wewnętrznych Kliniczny Szpital Wojewodzki nr 1
    Rzeszów, Poland
  • Centrum Badań Klinicznych
    Wrocław, 51-162, Poland
  • Samodzielny Publiczny Szpital im.Papieza Jana Pawla II
    Zamość, 22-400, Poland
  • Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital Kliniczny im. Barlickiego
    Łódź, 90-153, Poland
  • Klinika Chorób Wewnętrznych, Diabetologii i Farmakologii Klinicznej, Centralny Szpital Kliniczny
    Łódź, 92-216, Poland
  • Clinical Hospital Center "Dr Dragisa Misovic-Dedinje", Clinic for Internal Medicine, Gastroenterology Department
    Belgrade, 11000, Serbia
  • Clinical Hospital Center Zvezdara, Clinic for Internal Diseases, Clinical Department for Gastroenterology and Hepatology
    Belgrade, 11000, Serbia
  • University Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
    Belgrade, 11000, Serbia
  • Clinical Hospital Center "Bezanijska Kosa", Clinic for Internal Medicine, Department for Gastroenterology and Hepatology
    Belgrade, 11080, Serbia
  • Military Medical Academy, Clinic for Gastroenterology and Hepatology
    Belgrad, 11040, Serbia
  • University Clinical Center Kragujevac, Clinic for Internal Medicine, Gastroenterohepatology Center
    Kragujevac, 34000, Serbia
  • 'University Clinical Center Nis, Clinic for Gastroenterology and Hepatology
    Niš, 18000, Serbia
  • Institution: General Hospital Pančevo, Internal Diseases Department, Gastroenterology Section
    Pančevo, 26101, Serbia
  • 'Health Center Uzice, Internal Diseases Department, Gastroenterology Section
    Užice, 31000, Serbia
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
  • Hospital Clínic de Barcelona
    Barcelona, 08036, Spain
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, Spain
  • Hospital Universitario Ramón y Cajal
    Madrid, 28034, Spain
  • Hospital Puerta de Hierro Majadahonda
    Majadahonda, Spain
  • Hospital Marqués de Valdecilla
    Santander, 39008, Spain
  • Hospital Universitario Politecnico La Fe
    Valencia, Spain
  • Royal Free NHS Foundation Trust Hospital
    London, Londong NW3 2QG, United Kingdom
08

References and documents

Publications

  • 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. PubMed 30905652 ↗

Study documents

  • Study protocol · Sep 24, 2020
  • Statistical analysis plan · Sep 9, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03451292
Lead sponsor
Grifols Therapeutics LLC
Collaborators
Instituto Grifols, S.A.
Responsible party
Sponsor
First posted
Mar 1, 2018
Start date
Jul 24, 2018
Primary completion
May 21, 2024
Completion
May 21, 2024
Results posted
Jun 6, 2025
Last update
Jun 6, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Liver Cirrhosis→

Other studies from this sponsor

Grifols Therapeutics LLC

Start the discussion