Decompensated Cirrhosis and AscitesPhase 3PRECIOSANCT03451292
Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites
A Phase 3 study testing Albutein 20% and SMT in people with Decompensated Cirrhosis and Ascites, run by Grifols Therapeutics LLC at 66 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Cirrhosis and Ascites
- What is being tested?
- Albutein 20% and SMT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 66 sitesin 14 countries
- Study dates
- 24 Jul 2018to 21 May 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
66 sites in 14 countries.
66 sites in 14 countries
Poland9 sites
Oddział Gastroenterologii i Hepatologii Uniwersyteckie Centrum Kliniczne im. prof.K.Gibińskiego SUM w Katowicach
Katowice, 40-751
SP ZOZ Szpital Uniwersytecki w Krakowie, Zakład Endoskopii SIV 31Aug22
Krakow, 30-688
Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital Kliniczny im. Barlickiego
Lodz, 90-153
Klinika Chorób Wewnętrznych, Diabetologii i Farmakologii Klinicznej, Centralny Szpital Kliniczny
Lodz, 92-216
Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital Kliniczny im. Barlickiego
Lublin, 20954
ID Clinic
Mysłowice, 41-400
Klinika Gastroenterologii i Hepatologii z Pododdziałem Chorób Wewnętrznych Kliniczny Szpital Wojewodzki nr 1
Rzeszów
Centrum Badań Klinicznych
Wroclaw, 51-162
Samodzielny Publiczny Szpital im.Papieza Jana Pawla II
Zamość, 22-400
Serbia9 sites
Clinical Hospital Center "Dr Dragisa Misovic-Dedinje", Clinic for Internal Medicine, Gastroenterology Department
Belgrade, 11000
Clinical Hospital Center Zvezdara, Clinic for Internal Diseases, Clinical Department for Gastroenterology and Hepatology
Belgrade, 11000
University Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
Belgrade, 11000
Military Medical Academy, Clinic for Gastroenterology and Hepatology
Belgrade, 11040
Clinical Hospital Center "Bezanijska Kosa", Clinic for Internal Medicine, Department for Gastroenterology and Hepatology
Belgrade, 11080
University Clinical Center Kragujevac, Clinic for Internal Medicine, Gastroenterohepatology Center
Kragujevac, 34000
'University Clinical Center Nis, Clinic for Gastroenterology and Hepatology
Niš, 18000
Institution: General Hospital Pančevo, Internal Diseases Department, Gastroenterology Section
Pančevo, 26101
'Health Center Uzice, Internal Diseases Department, Gastroenterology Section
Užice, 31000
Bulgaria8 sites
MHAT "Pazardzhik" Ltd
Pazardzhik, 4400
MHAT"Sv. Pantelymon"
Plovdiv, 4000
MHAT " Hadzhi Dimitar" Ltd
Sliven, 8800
MHAT Sliven to MMA Sofia
Sliven, 8800
MHAT "Sveta Sofia"
Sofia, 1000
UMHAT "Sveti Ivan Rilski"
Sofia, 1000
UMHATEM "N.I.Pirogov"
Sofia, 1000
First Private MHAT Vratsa
Vratsa, 3000
United States7 sites
University of Missouri Hospital
Columbia, South Carolina, 65201
Southern California Research Center
Coronado, California, 92118
Dallas VA Medical Center
Dallas, Texas, 75216
University of Miami Hospital
Miami, Florida, 33136
Rutgers-New Jersey Medical School
Newark, New Jersey, 07103
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
McGuire VA Medical Center
Richmond, Virginia, 23249
Spain7 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Puerta de Hierro Majadahonda
Majadahonda
Hospital Marqués de Valdecilla
Santander, 39008
Hospital Universitario Politecnico La Fe
Valencia
France5 sites
Hôpital Minjoz - CHU Besaçon
Besançon, 25000
Hôpital Henri Mondor-Creteil
Créteil, 94010
CHU de Nice - Hôpital l'Archet 2
Nice, CS 23079
CHRU de Strasbourg - Hôpital Hautepierre
Strasbourg, 67200
Centre Hépato-Biliaire - Hôpital Universitaire Paul Brousse
Villejuif, 94804
Hungary5 sites
Magyar Honvédség Egészségügyi Központ Gasztroenterológiai Osztály
Budapest, 1062
Semmelweis Egyetem I. sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika
Budapest, 1082
Debreceni Egyetem Klinikai Központ Gasztroenterológiai Klinika
Debrecen, 4032
Markhot Ferenc Oktatókórház és Rendelőintézet
Eger, 3300
Albert Schweitzer Kórház
Hatvan, 3000
Germany4 sites
Charité - Universitaetsmedizin Berlin
Berlin, 13353
Universitätsklinikum Essen
Essen, 45147
Universitätsklinikum Frankfurt
Frankfurt, 60590
Universitätsklinikum Jena
Jena, 7740
Belgium3 sites
Université libre de Bruxelles
Brussels, 1070
Antwerp University Hospital
Edegem, 2650
UZ Leuven - Campus Gasthuisberg
Leuven, 3000
Bosnia and Herzegovina3 sites
University Clinical Centre of the Republic Srpska, Clinic for Internal Diseases, Department of gastroenterology, hepatology and toxicology with internal medicine
Mostar, 88000
Dr. Abdulah Nakas General Hospital, Department of Internal Medicine, Department of Gastroenterohepatology
Sarajevo
Zenica Cantonal Hospital, Department of Internal Medicine with hemodialysis, Department of Gastroenterology and hepatology
Zenica
Italy3 sites
Azienda Ospedaliero-Universitaria di Bologna Policlinico - S.Orsola
Bologna
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Azienda Ospedaliera di Padova
Padova, 35131
United Kingdom1 site
Royal Free NHS Foundation Trust Hospital
London, Londong, NW3 2QG
About this study
Official title: 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 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.
- Conditions
- Decompensated Cirrhosis and Ascites
- Being tested
- Albutein 20%, SMT
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albutein 20%Drug
Injectable solution
SMTOther
Participants received SMT according to institution standards for the management of decompensated cirrhosis.
| Study group | Role | What they receive |
|---|---|---|
| SMT + Albutein 20% | Experimental | 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. Receives: Drug: Albutein 20%; Other: SMT |
| SMT | Active comparator | Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis. Receives: Other: SMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)].
Measured: Up to Day 361
Secondary outcomes (7)
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)].
Measured: Up to Day 91
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)].
Measured: Up to Day 181
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)].
Measured: Up to Day 91
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)].
Measured: Up to Day 181
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)].
Measured: Up to Day 361
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.
Measured: Up to Day 361
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.
Measured: Up to Day 361
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start24 Jul 2018
- Primary completion21 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decompensated Cirrhosis and AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grifols Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto Grifols, S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451292
- Sponsor's protocol ID
- IG1601
- Other IDs
- 2016-001789-28, 2016
- Acronym
- PRECIOSA
- Status last verified
- May 2025
- First submitted
- 12 Feb 2018
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Mortality With Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites
- ClinicalTrials.gov ID
- NCT03451292
- Acronym / sponsor ID
- PRECIOSA / IG1601
- Conditions
- Decompensated Cirrhosis and Ascites
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Instituto Grifols, S.A.
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMT + Albutein 20% | Experimental | Drug: Albutein 20%, Other: SMTParticipants 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. |
| SMT | Active comparator | Other: SMTParticipants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albutein 20%Injectable solution | Drug | SMT + Albutein 20% |
| SMTParticipants received SMT according to institution standards for the management of decompensated cirrhosis. | Other | SMT, SMT + Albutein 20% |
Primary outcome
Time to Liver Transplantation or Death Through 1 Year After Randomization: Percentage of Participants With an Event
Time frame: Up to Day 361
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)].
7 secondary outcomes
Time to Liver Transplantation or Death Through 3 Months After Randomization: Percentage of Participants With an Event
Time frame: Up to Day 91
Time to Liver Transplantation or Death Through 6 Months After Randomization: Percentage of Participants With an Event
Time frame: Up to Day 181
Time to Death Through 3 Months After Randomization: Percentage of Participants With an Event
Time frame: Up to Day 91
Time to Death Through 6 Months After Randomization: Percentage of Participants With an Event
Time frame: Up to Day 181
Time to Death Through 1 Year After Randomization: Percentage of Participants With an Event
Time frame: Up to Day 361
Total Number of Paracenteses Through 1 Year After Randomization
Time frame: Up to Day 361
Number of Participants With Refractory Ascites According to the International Club of Ascites (ICA) Through 1 Year After Randomization
Time frame: Up to Day 361
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30905652Fernandez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
66 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albutein 20% and SMT in people with Decompensated Cirrhosis and Ascites, run by Grifols Therapeutics LLC at 66 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in Poland, Serbia, Bulgaria, United States, Spain and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Liver Transplantation or Death Through 1 Year After Randomization: Percentage of Participants With an Event (time frame: Up to Day 361). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03451292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.