Albumin
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | OPTISON | — | 2012-08-17 – 2025-05-09 | fda.gov ↗ |
| Approved | US (FDA) | OPTISON | — | 1997-12-31 | fda.gov ↗ |
Trials 97 · started per year
Also used as a comparator or background therapy in 84 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03950778 Comparator | Apr 2019 → Apr 2021 | infectious disease with sepsis | University of Pecs | Unknown | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT05080543 Comparator | Oct 2021 → Sep 2022 | infectious disease with sepsis | Amany Mousa Salama Muhammed | Unknown | No outcome recorded |
| Phase 1 | NCT04393168 Background | May → Jun 2020 | lymphedema | Nicole Lindenblatt | Completed | No outcome recorded |
| Phase 1 | NCT04701697 Comparator | Mar → Sep 2020 | — | The First Hospital of Jilin University | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03919773 Comparator | Oct 2018 → Jun 2023 | postural orthostatic tachycardia syndrome | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT01009567 Comparator | Jun 2009 → Jun 2013 | ovarian hyperstimulation syndrome | Royan Institute | Completed | No outcome recorded |
| Phase 210 trials | ||||||
| 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 | NCT06411743 Comparator | Sep 2021 → Aug 2022 | — | The First Hospital of Jilin University | Completed | 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→ Jun 2023 | acute kidney injury, cirrhosis of liver, hepatorenal syndrome | University of California, Los Angeles | Withdrawn | No outcome recorded |
| Phase 2 | NCT04390503 Comparator | Mar 2021 → Jan 2022 | COVID-19 | Andrew Eisenberger | Terminated | No outcome recorded |
| Phase 2 | NCT04701034 Comparator | Jan 2021 → Apr 2024 | habitual spontaneous abortion, pregnancy disorder with abortive outcome, pregnancy loss, recurrent, 4 | Aalborg University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04374539 Background | Apr 2020 → Jun 2021 | COVID-19 | Fundacion Clinic per a la Recerca Biomédica | Terminated | No outcome recorded |
| Phase 2 | NCT04109144 Comparator | Nov 2019 → Jul 2023 | cirrhosis of liver | Montefiore Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT03665311 Comparator | Mar 2019 → Jan 2020 | acute kidney injury, hypotensive disorder | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT02654782 Comparator | Jan 2016 → Oct 2017 | — | William C. Oliver | Terminated | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT03420144 Comparator | Jan 2018 → Jun 2020 | cirrhosis of liver | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | No outcome recorded |
| Phase 2/3 | NCT03415698 Comparator | Jul 2016 → Jul 2018 | cirrhosis of liver | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 2/3 | NCT00742690 Comparator | May 2005 → Dec 2014 | cirrhosis of liver, hepatorenal syndrome | University of Padova | Unknown | No outcome recorded |
| Phase 2/3 | NCT00742339 Background | May 2005 → Oct 2013 | cirrhosis of liver, hepatorenal syndrome | University of Padova | Terminated | No outcome recorded |
| Phase 314 trials | ||||||
| Phase 3 | NCT07139392 Comparator | Sep 2025 overdue | — | shaimaa hamdy | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05056220 Comparator | Feb 2024 → Sep 2026 expected | — | Aleksander Krag | Recruiting | No outcome recorded |
| Phase 3 | NCT06113848 Comparator | Sep 2023 → Sep 2024 | ischemic stroke | Tianjin Huanhu Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT06911554 Comparator | Jun 2023 → Sep 2024 | — | Tonghua Anrate Biopharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT06355479 Comparator | Apr → Nov 2023 | cirrhosis of liver | Healthgen Biotechnology Corp. | Completed | No outcome recorded |
| Phase 3 | NCT06630923 Comparator | Jan 2023 → Dec 2025 overdue | congestive heart failure | Democritus University of Thrace | Recruiting | No outcome recorded |
| Phase 3 | NCT05240391 Comparator | Feb 2021 → May 2022 | — | Asian Institute of Gastroenterology, India | Completed | No outcome recorded |
| Phase 3 | NCT04621617 Comparator | Nov 2020 → Dec 2021 | — | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 3 | NCT02192502 Comparator | Mar 2015 → Feb 2018 | acute kidney injury | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 3 | NCT01337934 Comparator | Oct 2013 → Oct 2016 | infectious disease with sepsis | University of Sao Paulo | Completed | No outcome recorded |
| Phase 3 | NCT00986817 Background | Nov 2009 → Mar 2015 | cirrhosis of liver | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT01758172 Comparator | Oct 2009 → Oct 2010 | — | Asan Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT00235495 Comparator | Jun 2006 → Feb 2013 | ischemic stroke | University of Miami | Terminated | No outcome recorded |
| Phase 3 | NCT00124228 Comparator | Nov 2004 → Oct 2008 | cirrhosis of liver | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase 424 trials | ||||||
| Phase 4 | NCT06892535 Comparator | Feb 2024 → Feb 2025 | hepatic vascular disorder | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 4 | NCT04705896 Comparator | Nov 2023 → Aug 2025 overdue | acute kidney injury, hypotensive disorder | Ottawa Hospital Research Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT05463471 Comparator | Aug 2022 → Dec 2025 overdue | — | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05148286 Comparator | Jan 2022 → Sep 2027 expected | infectious disease with sepsis | Asan Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT04216784 Comparator | Dec 2019 → Dec 2023 | cirrhosis of liver | Rush University Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT03202524 Comparator | Dec 2017 → Jul 2018 | cirrhosis of liver | Montefiore Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT04522635 Comparator | Jun 2015 → Dec 2017 | hypotensive disorder | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT02401490 Comparator | Apr 2015 → Mar 2018 | cirrhosis of liver, hepatic encephalopathy | Hospital Universitari Vall d'Hebron Research Institute | Unknown | No outcome recorded |
| Phase 4 | NCT02738190 Comparator | Jan 2015 → May 2016 | hemorrhagic disease | IRCCS Policlinico S. Donato | Completed | No outcome recorded |
| Phase 4 | NCT02270723 Comparator | Aug 2014 → Aug 2015 | blood coagulation disease | Kirsten Cleemann Rasmussen | Unknown | No outcome recorded |
| Phase 4 | NCT02728921 Comparator | Apr 2014 → Oct 2016 | pancreatic neoplasm | Region Skane | Completed | No outcome recorded |
| Phase 4 | NCT01559519 Comparator | Sep 2012 → Dec 2013 | hepatic encephalopathy | University of Roma La Sapienza | Completed | No outcome recorded |
| Phase 4 | NCT01530711 Background | Apr 2012 → Dec 2016 | cirrhosis of liver, hepatorenal syndrome | Pere Gines | Unknown | No outcome recorded |
| Phase 4 | NCT01288794 Comparator | Mar 2011 → Nov 2014 | cirrhosis of liver | University of Bologna | Completed | No outcome recorded |
| Phase 4 | NCT00936247 Comparator | Nov 2009 → Sep 2010 | impaired renal function disease | B. Braun Melsungen AG | Terminated | No outcome recorded |
| Phase 4 | NCT00886925 Comparator | Mar 2009 → Jul 2012 | hepatic encephalopathy | Hospital Universitari Vall d'Hebron Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT00839358 Comparator | Aug 2008 → Feb 2016 | hepatic encephalopathy, infectious disease with sepsis, kidney failure | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase 4 | NCT00570960 Comparator | Jun 2007 → Apr 2010 | infectious peritonitis | University of Virginia | Terminated | No outcome recorded |
| Phase 4 | NCT00327704 Comparator | Jul 2006 → Jun 2010 | infectious disease with sepsis | LFB | Completed | No outcome recorded |
| Phase 4 | NCT01174719 Comparator | Mar 2006 → Feb 2010 | coronary artery disorder, heart valve disorder | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT00308100 Comparator | Oct 2005 → Jul 2008 | — | Fresenius Kabi | Terminated | No outcome recorded |
| Phase 4 | NCT00761098 Comparator | May 2005 → May 2010 | cirrhosis of liver, infectious peritonitis | Weill Medical College of Cornell University | Unknown | No outcome recorded |
| Phase 4 | NCT00108355 Comparator | Dec 2003 → Aug 2010 | cirrhosis of liver | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 4 | NCT00708747 Comparator | Jul 1996 → Jun 2001 | autoinflammatory syndrome | Medical University of Vienna | Completed | No outcome recorded |
| Phase not applicable26 trials | ||||||
| — | NCT07002827 Background | Jun 2025 → Dec 2026 expected | cirrhosis of liver | Institute of Liver and Biliary Sciences, India | Recruiting | No outcome recorded |
| — | NCT06654687 Comparator | Oct 2024 → Feb 2025 | pregnancy disorder | Sameh Fathy | Completed | No outcome recorded |
| — | NCT05647200 Comparator | Oct 2023 → Jul 2024 | — | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
| — | NCT05346393 Comparator | Nov 2022 → Jun 2025 overdue | acute kidney injury, cirrhosis of liver, hepatorenal syndrome | Jena University Hospital | Recruiting | No outcome recorded |
| — | NCT05287100 Background | Jan 2022 → May 2023 | cirrhosis of liver | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT04816240 Background | May 2021 → Mar 2022 | cirrhosis of liver | Institute of Liver and Biliary Sciences, India | Unknown | No outcome recorded |
| — | NCT04356859 Comparator | Apr 2021 → Sep 2025 | — | American Burn Association | Completed | No outcome recorded |
| — | NCT04474262 Background | Jul 2020 → Mar 2021 | liver disorder | Institute of Liver and Biliary Sciences, India | Unknown | No outcome recorded |
| — | NCT04416282 Background | Jun 2020 → Jun 2022 | acute kidney injury, hepatorenal syndrome | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT04013113 Background | Jul 2019 → Jul 2020 | liver disorder | Institute of Liver and Biliary Sciences, India | Unknown | No outcome recorded |
| — | NCT03645642 Background | Sep → Dec 2018 | hepatobiliary disorder | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT03306914 Comparator | Oct 2017 → Feb 2019 | — | Cairo University | Completed | No outcome recorded |
| — | NCT03144713 Comparator | May 2017 → Apr 2018 | cirrhosis of liver | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT02811406 Comparator | Jun 2016 → Jun 2017 | hypotensive disorder | National University Hospital, Singapore | Unknown | No outcome recorded |
| — | NCT02788240 Background | May 2016 → Jul 2017 | liver failure | Institute of Liver and Biliary Sciences, India | Terminated | No outcome recorded |
| — | NCT02613052 Comparator | Jan 2016 → Jun 2017 | — | University of California, San Diego | Completed | No outcome recorded |
| — | NCT02573727 Background | Oct 2015 → Jan 2017 | liver failure | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT03547895 Comparator | Jun 2015 → May 2016 | cirrhosis of liver | Zagazig University | Completed | No outcome recorded |
| — | NCT02468089 Background | May 2015 → Aug 2017 | infectious peritonitis | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT02782819 Comparator | Sep 2014 → Aug 2018 | hypotensive disorder | Mahidol University | Unknown | No outcome recorded |
| — | NCT02756741 Comparator | Apr 2014 → Jul 2015 | cirrhosis of liver | All India Institute of Medical Sciences | Completed | No outcome recorded |
| — | NCT02123576 Background | Apr 2014 → Dec 2017 | hepatorenal syndrome | Patrick Northup, MD | Terminated | No outcome recorded |
| — | NCT01852630 Background | Dec 2012 → Dec 2015 | infectious peritonitis | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT02528097 Comparator | Sep 2010 → Jan 2015 | infectious peritonitis | NYU Langone Health | Terminated | No outcome recorded |
| — | NCT00511394 Comparator | May 2007 → Dec 2008 | cirrhosis of liver | Govind Ballabh Pant Hospital | Suspended | No outcome recorded |
| — | NCT00283400 Comparator | Jan 2006 → Jan 2011 | subarachnoid hemorrhage | Baylor College of Medicine | Terminated | No outcome recorded |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 184 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Albumin | “This study aims to evaluate whether the combination of Albumin and Furosemide can reduce the risk of Ovarian Hyperstimulation Syndrome in women undergoing intracytoplasmic...” NCT07568886 ↗121“We investigated the effect of albumin treatment (20% solution) on hypoalbuminemia, cardiocirculatory dysfunction, portal hypertension, and systemic inflammation in patients...” PMID 30905652 ↗ Mar 2019 “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 ↗ “Albumin, midodrine and octreotide therapy (standard of care for HRS)” NCT02123576 ↗ “IV albumin 20% 50 mL for every 1L of ascitic fluid drained” NCT02811406 ↗ “5% albumin solution (Albutein 5%)” NCT03702920 ↗ |
| 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 (Human) | “Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g human albumin /L, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).” NCT01531803 ↗8“Albumin (Human) 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma.” NCT04390503 ↗ “Albumin (Human) 20%, USP” NCT06355479 ↗ |
| Known as | Albumin 5% | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01561053 ↗ |
| Known as | Albumin 5% inj | “The group receiving receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery” NCT03699462 ↗ |
| Known as | Albutein | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02872142 ↗ |
| Known as | Albutein 200 g/L | “Drug: Albutein® 200 g/L or Plasbumin® 20” NCT03869385 ↗ |
| Known as | An Pu Lai Shi | “Human Albumin (An Pu Lai Shi®), strength: 10 g/vial (protein concentration 20%, 50 mL/vial), storage conditions: 2-8°C, protected from light; manufactured by Shanghai RAAS...” NCT06911554 ↗1“Human Albumin (An Pu Lai Shi®), strength: 10 g/vial (protein concentration 20%, 50 mL/vial), storage conditions: 2-8°C, protected from light; manufactured by Shanghai RAAS...” NCT06411743 ↗ |
| Known as | HAS | “The aim of this research study is to compare two different fluids (Human Albumin Solution (HAS) and Balanced Crystalloid that are given via a drip to patients with severe...” NCT04540094 ↗1“5% human albumin solution (HAS)” NCT01436292 ↗ |
| 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 20252“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 (HSA)” PMID 40699522 ↗ Jul 2025 |
| Known as | human albumin | “Treatment group (T): administration of 100 mL Human Albumin (20%), first dose directly after aortic cross clamping and blood cardioplegia administration, second dose after the...” NCT05647200 ↗54“The indocyanine green in 5% human albumin solution (tracer) (50 μL) will be injected intradermally in both forearms or both lower legs using MicronJet600 microneedles paying...” NCT04393168 ↗ “A phase II study was conducted primarily to determine whether plasma exchange with 5% human albumin is able to modify the concentration of beta-amyloid peptide in cerebrospinal...” NCT00742417 ↗ “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 ↗ “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 ↗ “Receive Human Albumin 20% Solution when albumin serum concentration is at 30 g/L or below” NCT06535945 ↗ “Intravenous human albumin 20% (100 mL) administered immediately after oocyte retrieval.” NCT07568886 ↗ “Starting dose: 60 g human albumin 20% (Albutein® 200 g/L, infusion solution) over 2-3 h” NCT03869385 ↗ “Plasma exchanges with 5% human albumin and fresh frozen plasma” NCT04374539 ↗ “200 mL human albumin (20%, Sanquin, Amsterdam, Netherlands)” NCT05647057 ↗ “Receive human albumin 20% infusion” NCT01009567 ↗ |
| 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 20253“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 ↗ “human serum albumin (HSA)” PMID 40699522 ↗ Jul 2025 |
| Known as | pHSA | “plasma-derived HSA (pHSA)” NCT06355479 ↗ |
| Known as | Plasbumin 20 | “Drug: Albutein® 200 g/L or Plasbumin® 20” NCT03869385 ↗ |
| Known as | Vialebex | “Effects of Albumin Administration in Septic Cirrhotic Patients With Child > 8 Unrelated to Spontaneous Bacterial Peritonitis on Renal Function and Survival: A Multicenter...” NCT01359813 ↗ |
| 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 ↗ |