Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites
Completed · Phase 3 · NCT03451292
Conditions: Decompensated Cirrhosis and Ascites
At a glance
- Research payments reported, 2025
- $344,551
- U.S. investigators named
- 7
- Sites paid
- 7
- Planned or actual enrollment
- 410
About the trial
- Sponsor
- Grifols Therapeutics LLC (with Instituto Grifols, S.A.)
- Tested
- Albutein 20% (drug), SMT (other)
- Dates
- Started 2018-07-24; completion 2024-05-21
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2025-06-06. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Grifols Therapeutics LLC reported $344,551 in research payments for this study in 2025 (16 payments).
Products named: Albutein
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Tarek I. Hassanein, M.D. Hepatology · Coronado, CA
- Paul Martin, MD Hepatology · West Hollywood, CA
- Rajender Reddy, M.D. Internal Medicine · Hammonton, NJ
- Nikolaos T. Pyrsopoulos, MD,PHD,MBA Hepatology · New York, NY
- Jacqueline G. O'leary, MD, MPH Gastroenterology · Dallas, TX
- Jasmohan S. Bajaj, MD Gastroenterology · Richmond, VA
- Syed M. Naqvi, MD Hematology & Oncology · Eau Claire, WI
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Dallas VA Research Corporation $127,819
- Southern California Research Center $103,727
- Mcguire Research Institute Inc $38,798
- University of Missouri Hospitals and Clinics $28,043
- University of Miami Microbiology and Immunology $24,209
- Hospital of Univ of Pennsylvania, PA $12,660
- Rutgers New Jersey Medical School $9,295
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.