Study on the Effects of Human Serum Albumin on Survival in Patients with Severe Acute-On-Chronic Liver Failure

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What is this study about?

This clinical trial is focused on studying a condition known as Acute-On-Chronic Liver Failure (ACLF), which occurs in people who already have liver cirrhosis and then experience a sudden worsening of their liver function. The study is particularly interested in patients with specific stages of this condition, referred to as ACLF-1b, ACLF-2, or ACLF-3a. These stages indicate varying levels of severity in the liver’s failure to function properly.

The treatment being tested in this study is called Human Serum Albumin, which is a protein derived from human blood. It is used in a solution form for infusion, meaning it is administered directly into the bloodstream through a vein. The specific product used in this trial is known as Albutein 50 g/l solution for infusion. The study aims to evaluate the effect of combining this treatment with standard medical care to see if it improves the 90-day survival rate of patients with ACLF.

Participants in the study will receive either the standard medical treatment alone or the standard treatment plus the Human Serum Albumin solution. The study will monitor the participants over a period to assess their overall survival and other health outcomes. The goal is to determine if the addition of the albumin solution can help improve the chances of survival for patients with this serious liver condition.

1 joining the study

Upon joining the study, eligibility is confirmed. Participants are individuals with cirrhosis and specific types of acute-on-chronic liver failure (ACLF-1b, ACLF-2, or ACLF-3a).

Participants must be between 18 and 79 years old and provide informed consent, either personally or through a representative if unable to do so.

2 treatment initiation

The treatment involves standard medical treatment (SMT) combined with plasma exchange using human serum albumin 5% (PE-A 5%).

The human serum albumin is administered as a solution for infusion through an intravenous route.

3 treatment duration

The primary goal is to evaluate the effect of the treatment on 90-day overall survival.

Secondary goals include assessing 90-day transplant-free survival and 28-day overall survival compared to SMT alone.

4 monitoring and follow-up

Participants are monitored throughout the study to assess the effectiveness and safety of the treatment.

The study is expected to conclude by September 30, 2025.

Who Can Join the Study?

  • Participants must be male or female and between 18 and 79 years old.
  • Participants must have cirrhosis with a condition called ACLF-1b, ACLF-2, or ACLF-3a. This condition can be detected either when they are admitted to the hospital or during their stay. It must be confirmed within a 10-day screening period.
  • Participants must be willing and able to provide written informed consent. If they cannot do this themselves, an authorized representative can provide consent on their behalf, following local laws and policies.
  • If a participant has a condition called hepatic encephalopathy, which affects the brain due to liver problems, a relative or legally authorized representative must provide consent if the participant is unable to do so.

Who Cannot Join the Study?

  • Patients with cirrhosis who have a condition called ACLF-1b, ACLF-2, or ACLF-3a. Cirrhosis is a liver disease, and ACLF stands for Acute-on-Chronic Liver Failure, which is a severe liver condition.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
Medical University Of Vienna Vienna Austria
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania
Katholieke Universiteit te Leuven Leuven Belgium
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Hopital Beaujon Clichy France
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj Cluj Napoca Romania
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD Sofia Bulgaria
KBC Zagreb Zagreb Croatia
University Of Debrecen Debrecen Hungary
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Clinical Medical Center Osijek Osijek Croatia
Semmelweis University Budapest Hungary
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila Bucharest Romania
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Emergency Institute For Cardiovascular Diseases And Transplant Targu Mures Romania
Hospital Paul Brousse Villejuif France
Universitaetsklinikum Leipzig AöR Leipzig Germany
Phdwt Tvnahwuagkxafhyy Kbizfbmb Kiyjwze Ikpm Bybprerizzhziy Kcuzzsg Pecs Hungary
Wquzpzbbbb Stxyzpd Ovdnkunlpponenpzhhyz It Tsusxyez Bniwjluj Bydgoszcz Poland
Sjhyvrgmahu Ptgxfjyfs Zyfyjw Zuczpvsa Ozffwc Zmebsnovbu Poavholiz Skxfcjf Sjfrwdstyrvxbub W Saxydsnt Weio Sywwc Stalowa Wola Poland
Mvndqetvseyej Hlxuibfk ffu Atppbh tfawexrcb Semub Sibyn Lta Sofia Bulgaria
Uzpnyhdyrq Haswxcsy Lnsnixwa Sofia Bulgaria
Uqjkphkwkknjbalrsoznp Mostsogd Aau Munster Germany
Ghydni Uzczklmdsh Fivckgikh Frankfurt Germany
Kpyfwvsc dtu Uuevumydkbpr Myrphabw Apg Munich Germany
Uiqvaxykim Dsisq Sbmzz Dt Rpvb Lq Svscypqz Rome Italy
Hygagiyi Vlll dfkwgegt Barcelona Spain
Cwvsxmzr Humujkvb Dayuexw Zagreb Croatia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.09.2018
Belgium Belgium
Not recruiting
01.09.2018
Bulgaria Bulgaria
Not recruiting
01.09.2018
Croatia Croatia
Not recruiting
01.09.2018
France France
Not recruiting
01.09.2018
Germany Germany
Not recruiting
01.09.2018
Hungary Hungary
Not recruiting
01.09.2018
Italy Italy
Not recruiting
01.09.2018
Poland Poland
Not recruiting
01.09.2018
Romania Romania
Not recruiting
01.09.2018
Spain Spain
Not recruiting
01.09.2018

Trial locations

Investigated drugs:

Human Serum Albumin 5% is a solution used in plasma exchange therapy. In this clinical trial, it is being tested to see if it can improve short-term survival in patients with acute-on-chronic liver failure. The therapy involves replacing a portion of the patient’s plasma with this albumin solution, which may help in managing the condition and reducing the risk of hospital mortality.

Cirrhosis with Acute-on-Chronic Liver Failure (ACLF) – Cirrhosis is a condition where the liver becomes severely scarred, affecting its ability to function properly. Acute-on-Chronic Liver Failure (ACLF) is a sudden worsening of liver function in individuals with pre-existing liver disease, such as cirrhosis. It is characterized by the rapid development of liver failure and can involve other organs, leading to complications. ACLF is classified into different grades, such as ACLF-1b, ACLF-2, and ACLF-3a, based on the severity and number of organ failures. The progression of ACLF can vary, with some patients experiencing a rapid decline in liver function. The condition requires careful monitoring and management to address the complications that arise.

Trial ID:
2022-502187-20-00
Protocol code:
IG1407
NCT ID:
NCT03702920
Trial Phase:
Therapeutic confirmatory (Phase III)

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