Drugs / Human Serum Albumin
Human Serum Albumin
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05249374 | Oct 2021 → May 2022 | — | Protgen Ltd | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07365475 | Jan 2026 → Jun 2028 expected | large artery stroke | Tianjin Huanhu Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07294391 | Dec 2025 → Dec 2026 expected | large artery stroke | Tianjin Huanhu Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07119463 | Oct 2024 → Jun 2026 overdue | gastric cancer, hypoproteinemia, hypercatabolic | The First Hospital of Jilin University | Recruiting | No outcome recorded |
| Phase 2 | NCT01684462 | Sep 2012 → Sep 2014 | cerebral infarction | Seoul St. Mary's Hospital | Terminated | No outcome recorded |
| Phase 2 | NCT00773110 | Dec 2008 → May 2011 | autoinflammatory syndrome | Imperial College London | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05858853 | May → Sep 2023 | cirrhosis of liver | Protgen Ltd | Completed | No outcome recorded |
| Phase 2/3 | NCT00152685 | — | brain injury | University Hospital, Angers | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02755155 | Sep 2016 → Aug 2019 | — | University Hospital, Strasbourg, France | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable2 trials | ||||||
| — | NCT06629116 | Jan 2024 → Dec 2026 expected | ischemic stroke | Tingyu-Yi | Recruiting | No outcome recorded |
| — | NCT06111261 | Nov 2023 → Jul 2025 | hemorrhagic disease | Seoul National University Hospital | Unknown | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT07851688 Comparator | Oct 2026 → Dec 2028 expected | — | Gan & Lee Pharmaceuticals. | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06553456 Comparator | Aug 2024 → May 2025 | cirrhosis of liver | Protgen Ltd | Completed | No outcome recorded |
| Phase 4 | NCT02331745 Background | Oct 2013 → Apr 2016 | alcoholic liver disease, hepatitis B virus infection, liver failure | Beijing 302 Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01689506 Comparator | Dec 2012 → Sep 2013 | — | Fresenius Kabi | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01553617 Comparator | Oct 2012 → Jan 2014 | postoperative ventricular dysfunction | Fresenius Kabi | Completed | No outcome recorded |
| Phase 4 | NCT00860405 Comparator | Mar 2009 → Aug 2010 | cardiac valvular defect | Fresenius Kabi | Completed | Met primary |
| — | NCT02975726 Background | Jan 2017 → May 2018 | cirrhosis of liver | University of Manitoba | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 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. |
All press releases naming this drug 1 release
| 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 ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Human serum albumin | “Human serum albumin is an important biological molecule that plays a critical role in maintaining intracellular osmotic pressure, combating oxidative stress, and suppressing...” NCT06629116 ↗17“Standard treatment includes reduced glutathione, glycyrrhizin, ademetionine,polyene phosphatidylcholine, alprostadil, and human serum albumin) on the day of admission.” NCT02331745 ↗ “200ml of 20% Human Serum Albumin” NCT06111261 ↗ “20% Human serum albumin(300 mL)” NCT00773110 ↗ |
| Known as | HSA | “5% Albumin-supplemented arm: Human Serum Albumin (HSA 50g/L, solution for infusion)” NCT01689506 ↗ |
| Known as | human albumin | “Human albumin is the most abundant protein in plasma.” NCT07365475 ↗ |
| Modality | Protein / enzyme biologic | “hyperoncotic human serum albumin” NCT00152685 ↗ |
| Route | Intravenous | “intravenously infused” NCT01684462 ↗ |