Study Summary
This trial will compare the standard treatment for decompensated cirrhosis plus Albutein to standard treatment alone, in order to evaluate the efficacy of Albutein.
- Decompensated Cirrhosis and Ascites
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: 12 months
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Standard Medical Treatment
1 of 2
Standard Medical Treatment + Albutein 20%
1 of 2
Active Control
Experimental Treatment
410 Total Participants · 2 Treatment Groups
Primary Treatment: Standard medical treatment · No Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Iowa | 66.7% |
| Texas | 33.3% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Dallas VA Medical Center | 33.3% |
| Azienda Ospedaliero-Universitaria di Modena | 33.3% |
| Azienda Ospedaliera di Padova | 33.3% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
- Fernández, Javier, Joan Clària, Alex Amorós, Ferrán Aguilar, Miriam Castro, Mireia Casulleras, Juan Acevedo, et al.. 2019. “Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients with Decompensated Cirrhosis”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2019.03.021.
- 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.
- 2018. "Effects of Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03451292.
Frequently Asked Questions
What is the FDA's stance on Standard medical treatment?
"Standard medical treatment received a score of 3." - Anonymous Online Contributor
What is the most usual form of medical care given for this condition?
"Peritonitis is most commonly treated with standard medical interventions. However, this treatment can also be used to address various other conditions such as liver failure and respiratory distress syndrome in adults." - Anonymous Online Contributor
Are there other examples in the medical literature of Standard medical treatment?
"The first clinical trial for standard medical treatment was conducted in 2007 at Herbert Irving Pavillion 11th Floor. Since then, a total of 178 clinical trials have been completed. As of now, there are 139 active trials recruiting patients; many of these are based in Columbia, South Carolina." - Anonymous Online Contributor
What is the enrollment for this clinical trial?
"That is correct. The information available on clinicaltrials.gov indicates that this study was originally posted on July 24th, 2018 and is still recruiting participants. Currently, 410 individuals are needed for the trial which is being conducted at 9 different locations." - Anonymous Online Contributor
Has a trial like this been conducted before?
"Standard medical treatment has a long research history, with the first clinical trial taking place in 2007. That initial study was sponsored by Celgene Corporation and involved 47 patients. After receiving Phase 1 & 2 drug approval in 2007, there are now 139 live studies involving Standard medical treatment across 33 countries and 918 cities" - Anonymous Online Contributor
Could you please inform me how many different locations are conducting this trial at the moment?
"There are many medical centres participating in this trial, some of which include University of Missouri Hospital, University of Ottawa, and University Health Network - Toronto General Hospital." - Anonymous Online Contributor
Are there any unfilled positions in this trial for potential participants?
"That is correct. The clinical trial, which was originally posted on July 24th, 2018 and updated on October 28th, 2020, is actively recruiting participants. 9 different locations are looking for a total of 410 individuals to fill the open slots." - Anonymous Online Contributor