Drugs / Human Albumin
Human Albumin
also known as
Albumin (Human) · An Pu Lai Shi · HAS · Albumin · Albutein · Albutein 200 g/L · HSA · human serum albumin · +3 more
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 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04641364 | Jun 2019 → May 2020 | — | The First Hospital of Jilin University | Completed | No outcome recorded |
| Phase 1 | NCT01747408 | Jun 2006 → Jul 2010 | subarachnoid hemorrhage | Baylor College of Medicine | Terminated | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT05895136 | Jul 2024 → Sep 2025 overdue | chronic liver failure, cirrhosis of liver | European Foundation for Study of Chronic Liver Failure | Recruiting | No outcome recorded |
| Phase 2 | NCT05645887 | Feb → May 2024 | infectious disease with sepsis | Albimmune SL | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04418739 | Jan 2020 → Nov 2022 | gastroparesis, intestinal perforation, malignant pancreatic neoplasm | Universiti Kebangsaan Malaysia Medical Centre | Unknown | No outcome recorded |
| Phase 2 | NCT02872142 | Aug 2016 → Aug 2019 | amyotrophic lateral sclerosis | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 2 | NCT00742417 | Jul 2007 → Feb 2011 | Alzheimer disease | Grifols, S.A. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05208242 | Nov 2023 → Apr 2025 | infectious disease with sepsis | Manchester University NHS Foundation Trust | Completed | No outcome recorded |
| Phase 37 trials · 2 missed | ||||||
| Phase 3 | NCT07212582 | Dec 2025 → Dec 2029 expected | infectious disease with sepsis | Mahidol University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03365414 | Jan 2022 → Oct 2023 | postural orthostatic tachycardia syndrome | University of Alberta | Withdrawn | No outcome recorded |
| Phase 3 | NCT04540094 | Jun 2021 → Sep 2022 | infectious disease with sepsis | University of Edinburgh | Completed | No outcome recorded |
| Phase 3 | NCT04071041 | Oct 2019 → Oct 2021 | hypoproteinemia, hypercatabolic, pneumonia | Jordi Carratala | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03869385 | Oct 2019 → Jul 2022 | infectious disease with sepsis | Jena University Hospital | Terminated | Missed primary |
| Phase 3 | NCT00796419 | Jan 2009 → Nov 2015 | acute lung injury, acute respiratory distress syndrome | Emory University | Terminated | No outcome recorded |
| Phase 3 | NCT01359813 | Dec 2008 → Sep 2011 | bacterial infectious disease with sepsis, cirrhosis of liver, kidney failure | Centre Hospitalier Universitaire de Besancon | Terminated | Missed primary |
| Phase 48 trials | ||||||
| Phase 4 | NCT06107335 | Jul 2025 → Dec 2026 expected | preeclampsia | The University of Texas Health Science Center, Houston | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06535945 | Mar 2025 → Apr 2028 expected | acute kidney injury | Rennes University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06681415 | Sep 2022 → Dec 2023 | — | Pauls Stradins Clinical University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03373318 | Jan 2018 → Aug 2019 | acute kidney injury | Sant Pau Research Institute | Unknown | No outcome recorded |
| Phase 4 | NCT03167645 | Jun 2017 → Dec 2019 | — | Technical University of Munich | Completed | No outcome recorded |
| Phase 4 | NCT01531803 | Feb → Jul 2015 | — | Kedrion S.p.A. | Terminated | No outcome recorded |
| Phase 4 | NCT01436292 | Sep 2011 → Sep 2015 | — | University of Montreal Hospital Centre (CHUM) | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT01822600 | Jan 2010 → Aug 2011 | active peptic ulcer disease | National Cheng-Kung University Hospital | Completed | No outcome recorded |
| Phase not applicable9 trials · 1 missed | ||||||
| — | NCT07685093 | Jul → Oct 2026 expected | idiopathic nephrotic syndrome | Qamar Shafiq | Not yet recruiting | No outcome recorded |
| — | NCT06483737 | Jun 2025 → Jun 2027 expected | hepatic encephalopathy | General Hospital of Shenyang Military Region | Recruiting | No outcome recorded |
| — | NCT06548477 | Aug 2024 → Jul 2027 expected | acquired aneurysmal subarachnoid hemorrhage | Hamad Medical Corporation | Recruiting | No outcome recorded |
| — | NCT06370078 | Jun → Nov 2024 | infectious disease with sepsis | Egymedicalpedia | Unknown | No outcome recorded |
| — | NCT05647057 | Jul 2023 → Jul 2024 | — | Amsterdam UMC, location VUmc | Completed | No outcome recorded |
| — | NCT07568886 | Apr 2019 → Apr 2023 | ovarian hyperstimulation syndrome | Al-Nahrain University | Completed | No outcome recorded |
| — | NCT02882074 | Jun 2016 → Feb 2020 | — | The Cleveland Clinic | Completed | Missed primary |
| — | NCT02448160 | Jan 2016 → Dec 2017 | cirrhosis of liver | Sequana Medical N.V. | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00617864 | Sep 2007 → ? | ovarian hyperstimulation syndrome | Yale University | Withdrawn | No outcome recorded |
| Comparator or background therapy28 trials | ||||||
| Phase 0 | NCT03950778 Comparator | Apr 2019 → Apr 2021 | infectious disease with sepsis | University of Pecs | 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 1/2 | NCT01009567 Comparator | Jun 2009 → Jun 2013 | ovarian hyperstimulation syndrome | Royan Institute | Completed | No outcome recorded |
| Phase 2 | NCT06411743 Comparator | Sep 2021 → Aug 2022 | — | The First Hospital of Jilin University | Completed | No outcome recorded |
| Phase 2 | NCT04390503 Comparator | Mar 2021 → Jan 2022 | COVID-19 | Andrew Eisenberger | Terminated | No outcome recorded Stop: Enrollment |
| 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 Stop: Enrollment |
| Phase 2 | NCT02654782 Comparator | Jan 2016 → Oct 2017 | — | William C. Oliver | Terminated | No outcome recorded Stop: Business |
| Phase 2/3 | NCT00742339 Background | May 2005 → Oct 2013 | cirrhosis of liver, hepatorenal syndrome | University of Padova | Terminated | No outcome recorded |
| Phase 3 | NCT05056220 Comparator | Feb 2024 → Sep 2026 overdue | — | Aleksander Krag | Recruiting | 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 | NCT02192502 Comparator | Mar 2015 → Feb 2018 | acute kidney injury | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 3 | NCT00124228 Comparator | Nov 2004 → Oct 2008 | cirrhosis of liver | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase 4 | NCT04216784 Comparator | Dec 2019 → Dec 2023 | cirrhosis of liver | Rush University Medical Center | Terminated | 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 | NCT02270723 Comparator | Aug 2014 → Aug 2015 | blood coagulation disease | Kirsten Cleemann Rasmussen | Unknown | No outcome recorded |
| Phase 4 | NCT01288794 Comparator | Mar 2011 → Nov 2014 | cirrhosis of liver | University of Bologna | Completed | No outcome recorded |
| Phase 4 | NCT00570960 Comparator | Jun 2007 → Apr 2010 | infectious peritonitis | University of Virginia | Terminated | 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 |
| — | NCT05647200 Comparator | Oct 2023 → Jul 2024 | — | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
| — | NCT04356859 Comparator | Apr 2021 → Sep 2025 | — | American Burn Association | Completed | No outcome recorded |
| — | NCT02613052 Comparator | Jan 2016 → Jun 2017 | — | University of California, San Diego | Completed | 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 |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-12-20 | Grifols Therapeutics LLC | Grifols announces topline phase 3 data on long-term Albutein® (albumin [human] U.S.P.) therapy for decompensated cirrhosis with ascites grifols.com ↗ |
| 2023-07-18 | Grifols Therapeutics LLC | Grifols completes enrollment in phase 3 study of long-term Albutein® (albumin-human injection) therapy for patients with decompensated cirrhosis grifols.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 61 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| 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 ↗50“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 ↗ “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 | 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 ↗ |
| 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 | 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 | “human serum albumin (HSA)” PMID 40699522 ↗ Jul 2025 |
| Known as | human serum albumin | “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 ↗ |
| Modality | Protein / enzyme biologic | “HA is a major protein found in blood” NCT00283400 ↗ |
| Route | Intravenous | “Treatment arm one will consist of human albumin, 1.5 g/kg intravenously administered at the time of enrollment and 1.0 g/kg administered on day three after enrollment.” NCT00570960 ↗ |