Drugs / Albumin
last change 10 days ago re-read 9 days ago

Albumin

Protein / enzyme biologic

Developed for
cirrhosis of liver · ischemic stroke · acute kidney injury · hepatorenal syndrome · infectious disease with sepsis · infectious peritonitis · kidney failure · liver disorder
+25 more · liver failure · plasma protein metabolism disease · acute respiratory distress syndrome · adrenomyeloneuropathy · amyotrophic lateral sclerosis · anuria · bacterial infectious disease · cerebral artery occlusion · cholangitis · decubitus ulcer · Dengue hemorrhagic fever · disease related to solid organ transplantation · esophageal varices with bleeding · hepatic encephalopathy · hepatocellular carcinoma · impaired renal function disease · intracerebral hemorrhage · pneumonia · tooth disorder · urinary tract infection · autoinflammatory syndrome · hemorrhagic disease · hepatic vascular disorder · hypotensive disorder · postural orthostatic tachycardia syndrome
Investigated by
Institute of Liver and Biliary Sciences, India · Grifols · Hospital Clinic of Barcelona · University Hospital, Linkoeping · Baxter Healthcare Corporation · Capital Medical University
+75 more · Insel Gruppe AG, University Hospital Bern · McGill University Health Centre/Research Institute of the McGill University Health Centre · Tianjin Huanhu Hospital · Yonsei University · Aalborg University Hospital · Aarhus University Hospital · Alexander Flannery, 859-323-4011 · Anders Perner · Anna Cruceta · Baylor College of Medicine · Bayside Health · Bispebjerg Hospital · Canadian Blood Services · Central Hospital, Nancy, France · Centro Medico Issemym · Collaboration of Research in Intensive Care · Copenhagen University Hospital, Hvidovre · Copenhagen University Hospital, Rigshospitalet · Danish Intensive Care Database · EASL - CLIF Consortium · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Fundacion Clinic per a la Recerca Biomédica · GC Pharma · Georgetown University · Grifols Therapeutics LLC · Guangxi Medical University · Gødstrup Hospital · Hainan People's Hospital · Hamilton Health Sciences Corporation · Helsinki University Central Hospital · Herlev Hospital · Hillerod Hospital, Denmark · Hospital de Clinicas de Porto Alegre · Hunter Holmes Mcguire Veteran Affairs Medical Center · Indonesia University · Istituto Di Ricerche Farmacologiche Mario Negri · Joachim Zdolsek · Jose J Zaragoza, MD MSc · Karolinska Institutet · Karolinska University Hospital · King Edward Medical University · King George's Medical University · Kolding Sygehus · McGuire Research Institute · Ministry of Health, France · North Denmark Region · Novartis · Odense University Hospital · Oslo University Hospital · Ottawa Hospital Research Institute · Post Graduate Institute of Medical Education and Research, Chandigarh · Pujol, Aurora, M.D. · R2D2 Retinoids, Reproduction Developmental Diseases · Randers Regional Hospital · Region Capital Denmark · Region Zealand · Seoul National University Hospital · Slagelse Hospital · Sodertalje Hospital · Southern Medical University, China · Steno Diabetes Center Copenhagen · Tampere University · The National University Hospital of Iceland · University Hospital Hradec Kralove · University Hospital, Basel, Switzerland · University Hospital, Clermont-Ferrand · University Medical Center Groningen · University of Alberta · University of Copenhagen · University of Turin, Italy · Université d'Auvergne · Viborg Regional Hospital · Xuanwu Hospital, Beijing · Zealand University Hospital · all 81 on the full record

Trials 64 · started per year

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT06172387 Nov 2023 → Dec 2024 ischemic stroke Tianjin Huanhu Hospital Unknown No outcome recorded
Phase 1 NCT05953623 Aug 2023 → Jun 2024 cerebral artery occlusion, ischemic stroke Tianjin Huanhu Hospital Completed No outcome recorded
Phase 1 NCT02716597 Mar 2016 → Jan 2019 — Alexander Flannery, 859-323-4011 Terminated No outcome recorded Stop: Enrollment
Phase 1/21 trial
Phase 1/2 NCT00228657 Jul 2002 → Aug 2003 decubitus ulcer Bayside Health Completed No outcome recorded
Phase 212 trials · 1 met primary · 1 missed
Phase 2 NCT07415655 Feb 2026 → Feb 2027 expected ischemic stroke University Hospital Hradec Kralove Recruiting No outcome recorded
Phase 2 NCT06538844 Aug → Dec 2024 ischemic stroke Capital Medical University Completed Met primary
Phase 2 NCT03941405 Feb 2020 → Dec 2024 cirrhosis of liver Fundacion Clinic per a la Recerca Biomédica Completed No outcome recorded
Phase 2 NCT05867602 Mar 2019 → Mar 2027 expected — Baylor College of Medicine Recruiting No outcome recorded
Phase 2 NCT03585257 Jun 2018 → Feb 2022 cirrhosis of liver, hepatic encephalopathy Hunter Holmes Mcguire Veteran Affairs Medical Center Completed No outcome recorded
Phase 2 NCT01587222 Jul 2016 → Jul 2017 hepatorenal syndrome, kidney failure Anna Cruceta Withdrawn No outcome recorded
Phase 2 NCT02479802 Nov 2014 → Jun 2016 amyotrophic lateral sclerosis Grifols Completed No outcome recorded
Phase 2 NCT01133795 Feb 2010 → Jun 2016 cirrhosis of liver, kidney failure Hospital Clinic of Barcelona Completed No outcome recorded
Phase 2 NCT00990509 Sep 2009 → Jun 2013 intracerebral hemorrhage Georgetown University Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00819416 Feb → Oct 2009 infectious disease with sepsis Ottawa Hospital Research Institute Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT06224777 Jan → Dec 2022 — King Edward Medical University Completed No outcome recorded
Phase 2/3 NCT04303416 Mar 2020 → Feb 2021 adrenomyeloneuropathy Pujol, Aurora, M.D. Completed No outcome recorded
Phase 2/3 NCT00240045 Oct 2005 → Jul 2007 hepatorenal syndrome University of Alberta Completed No outcome recorded
Phase 310 trials · 1 met primary · 1 missed
Phase 3 NCT07597135 Jun 2026 → Sep 2028 expected tooth disorder ahmed mostafa ahmed abo el soud Not yet recruiting No outcome recorded
Phase 3 NCT07395141 Mar → May 2026 overdue cirrhosis of liver, esophageal varices with bleeding King George's Medical University Not yet recruiting No outcome recorded
Phase 3 NCT07263308 Dec 2025 → Jun 2027 expected ischemic stroke Capital Medical University Recruiting No outcome recorded
Phase 3 NCT07072572 Mar → Dec 2023 acute kidney injury, cirrhosis of liver Centro Medico Issemym Completed No outcome recorded
Phase 3 NCT03702920 Jun 2019 → Apr 2025 liver disorder Grifols Terminated Met primary Stop: Business
Phase 3 NCT03654001 May 2019 → Oct 2024 infectious disease with sepsis Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Completed No outcome recorded
Phase 3 NCT03974074 Mar 2019 → Dec 2020 hepatocellular carcinoma, plasma protein metabolism disease Guangxi Medical University Unknown No outcome recorded
Phase 3 NCT03451292 Jul 2018 → May 2024 — Grifols Therapeutics LLC Completed Missed primary
Phase 3 NCT04076254 Oct 2016 → Sep 2019 Dengue hemorrhagic fever Indonesia University Unknown No outcome recorded
Phase 3 NCT02055872 Sep 2014 → Oct 2016 plasma protein metabolism disease Hamilton Health Sciences Corporation Completed No outcome recorded
Phase 416 trials · 3 missed
Phase 4 NCT06667999 Jun 2025 → Dec 2035 expected — Anders Perner Recruiting No outcome recorded
Phase 4 NCT05726136 Oct 2023 → Oct 2026 expected benign neoplasm, colorectal cancer, female reproductive organ cancer, malignant urinary system neoplasm Joachim Zdolsek Recruiting No outcome recorded
Phase 4 NCT05391607 May 2022 → Mar 2023 — Insel Gruppe AG, University Hospital Bern Completed No outcome recorded
Phase 4 NCT05441878 Aug 2020 → Oct 2023 cirrhosis of liver Post Graduate Institute of Medical Education and Research, Chandigarh Unknown No outcome recorded
Phase 4 NCT04184401 Jan 2020 → Nov 2021 — Seoul National University Hospital Completed No outcome recorded
Phase 4 NCT03848507 Mar 2019 → Feb 2020 — Insel Gruppe AG, University Hospital Bern Completed No outcome recorded
Phase 4 NCT03699462 Nov 2018 → Oct 2020 coronary artery disorder Yonsei University Completed Missed primary
Phase 4 NCT03453320 Feb 2018 → Jan 2019 — University Hospital, Linkoeping Completed No outcome recorded
Phase 4 NCT02560519 Mar 2017 → Apr 2020 — Helsinki University Central Hospital Completed Missed primary
Phase 4 NCT02952378 Oct 2016 → Jan 2019 — University Hospital, Linkoeping Completed No outcome recorded
Phase not applicable19 trials · 1 met primary · 1 missed
— NCT07417969 Jun 2025 → Sep 2026 overdue anuria Jose J Zaragoza, MD MSc Recruiting No outcome recorded
— NCT06809088 Jan 2025 → Jan 2026 overdue acute kidney injury, cirrhosis of liver Institute of Liver and Biliary Sciences, India Not yet recruiting No outcome recorded
— NCT06245590 Feb 2024 → Jan 2025 cirrhosis of liver Institute of Liver and Biliary Sciences, India Unknown No outcome recorded
— NCT06091345 Dec 2023 → Dec 2025 cirrhosis of liver Institute of Liver and Biliary Sciences, India Completed No outcome recorded
— NCT06026267 Oct 2023 → Dec 2024 overdue cirrhosis of liver, infectious peritonitis Institute of Liver and Biliary Sciences, India Recruiting No outcome recorded
— NCT06076330 Sep 2023 → Aug 2024 cirrhosis of liver Institute of Liver and Biliary Sciences, India Unknown No outcome recorded
— NCT05937048 Jul 2023 → Nov 2024 cirrhosis of liver Institute of Liver and Biliary Sciences, India Completed No outcome recorded
— NCT04679571 Dec 2020 → Sep 2022 cirrhosis of liver Institute of Liver and Biliary Sciences, India Unknown No outcome recorded
— NCT04437810 Jul 2020 → Apr 2022 acute kidney injury, cirrhosis of liver Institute of Liver and Biliary Sciences, India Unknown No outcome recorded
— NCT04273373 Mar → Dec 2020 infectious peritonitis Institute of Liver and Biliary Sciences, India Completed No outcome recorded
Comparator or background therapy57 trials
Phase 1 NCT05080543 Comparator Oct 2021 → Sep 2022 infectious disease with sepsis Amany Mousa Salama Muhammed Unknown No outcome recorded
Phase 1/2 NCT03919773 Comparator Oct 2018 → Jun 2023 postural orthostatic tachycardia syndrome University of Texas Southwestern Medical Center Completed No outcome recorded
Phase 2 NCT06812390 Comparator Feb 2025 → Dec 2026 expected cirrhosis of liver Anahita Rabiee MD MHS Recruiting No outcome recorded
Phase 2 NCT06052176 Comparator Nov 2023 → Oct 2026 expected cirrhosis of liver, hepatic encephalopathy Hunter Holmes Mcguire Veteran Affairs Medical Center Recruiting No outcome recorded
Phase 2 NCT04048707 Background Jul 2021 → Jun 2023 acute kidney injury, cirrhosis of liver, hepatorenal syndrome University of California, Los Angeles Withdrawn No outcome recorded Stop: Business

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2024-12-20 Grifols Therapeutics LLC Results Grifols announces topline phase 3 data on long-term Albutein® (albumin [human] U.S.P.) therapy for decompensated cirrhosis with ascites grifols.com ↗
Further, a notable improvement in time-to-liver transplant or death at three months was observed for the study treatment plus SMT group of patients, when compared with the patients treated only with SMT.
2020-07-27 Grifols Therapeutics LLC Results Results of Grifols’ AMBAR clinical trial published in Alzheimer's & Dementia: The Journal of the Alzheimer’s Association grifols.com ↗
The findings of the AMBAR clinical trial demonstrate a delay in the cognitive and functional decline in AD patients when their plasma is replaced with albumin and immunoglobulin (plasma-derived proteins) following the process of plasma extraction, using the plasmapheresis technique.
2019-05-30 BeOne Medicines Regulatory BeiGene Announces Acceptance of Supplemental Import Drug Application in China for ABRAXANE® in Metastatic Pancreatic Cancer beonemedicines.com ↗

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 123 sources stand behind the page.

FieldValueCited text
Known as Albumin “We investigated the effect of albumin treatment (20% solution) on hypoalbuminemia, cardiocirculatory dysfunction, portal hypertension, and systemic inflammation in patients...” PMID 30905652 ↗ Mar 2019
120

“nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be...” NCT04013113 ↗

“all patients receive albumin perfusion at the dose 8 g/l of removed ascites and Terlipressin (1mg) or placebo, administrated before and at the end of the paracentesis.” NCT00986817 ↗

“Standard Medical Therapy will include nutritional support, rifaximin, lactulose, bowel wash, albumin, diuretics, multivitamins and antibiotics as required” NCT03420144 ↗

“200cc of 20% human albumin with 15 cc per kg of crystalloid will be administered over 1\~2h for initial fluid resuscitation.” NCT05148286 ↗

“Nutritional support, rifaximin, lactulose, bowel wash, albumin, diuretics, multivitamins and antibiotics.” NCT03415698 ↗

“Albumin infusion 1g/kg/day - maximum 20gm/day and repeat till serum albumin reaches 2.8g/dl” NCT05287100 ↗

“Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)” NCT02528097 ↗

“Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)” NCT00761098 ↗

“The standard treatment of HRS-AKI is with the infusion of albumin and terlipressin.” NCT05346393 ↗

“Patient will receive 5% albumin or gelatin solution during shock resuscitation” NCT02782819 ↗

Show 110 more sources

Known as Albuman “Albuman® 200g/L (Sanquin, the Netherlands) is a solution containing 200 g/l (20%) of total protein of which at least 95% is human albumin.” NCT02560519 ↗
Known as Albumin 5% inj “The group receiving receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery” NCT03699462 ↗
Known as HSA “Intra-arterial infusion of human serum albumin (HSA) may offer neuroprotective benefits; however, its safety and feasibility have not been established when delivered via the...” PMID 40921621 ↗ Sep 2025
1

“In 2016, a study showed that in a rat model of normotensive endotoxemia, the infusion of 4% or 20% Human Serum Albumin "HSA" restored microvascular perfusion in otherwise...” NCT05080543 ↗

Known as Human Albumin “Human Albumin In parallel with fluid administration for volume resuscitation, patients will receive 400 ml of 20% albumin solution both at randomization (D0) and at day 1 (D1).” NCT03654001 ↗
3

“human albumin, 25%, 2.0g/kg intravenously (or equivalent volume of saline control), infused over 2 h, commencing within 5 hours of stroke onset” NCT00235495 ↗

“Human Albumin 20% 1.5 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 1 g/kg body weight (Maximum 100g)on day 3” NCT06026267 ↗

“Human albumin will be given intravenously at the dose of 1 g/kg of body weight on the first day followed by 20-40 g/day.” NCT00742690 ↗

Known as Human Albumin Grifols 200 g/l, solution for infusion “Human Albumin Grifols 200 g/l, solution for infusion” NCT03941405 ↗
Known as human serum albumin “Intra-arterial infusion of human serum albumin (HSA) may offer neuroprotective benefits; however, its safety and feasibility have not been established when delivered via the...” PMID 40921621 ↗ Sep 2025
2

“In 2016, a study showed that in a rat model of normotensive endotoxemia, the infusion of 4% or 20% Human Serum Albumin "HSA" restored microvascular perfusion in otherwise...” NCT05080543 ↗

“Human serum albumin, at 2 g/kg, administered over 2 hours by intravenous infusion” NCT00235495 ↗

Action Restore “albumin replacement in addition to crystalloids” PMID 24635772 ↗ Mar 2014
Modality Protein / enzyme biologic “Biological: Albumin” NCT00235495 ↗
Route Intravenous “Intravenous Albumin at a dose of 8g/liter of ascitic fluid removed” NCT00108355 ↗