biostudies-literatureWang XNational Science Fund of ChinaProgram for JLU Science and Technology Innovative Research Team91-101https://www.ebi.ac.uk/biostudies/studies/S-EPMC12923478biostudies-literatureUnknown20(1)<h4>Background</h4>Recombinant human serum albumin (rHA) is a promising alternative to human serum albumin (HSA) for managing ascites in cirrhotic patients. This phase Ib study aims to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) profiles of rHA in this population.<h4>Methods</h4>This randomized, open-label, phase Ib trial was conducted between December 2019 and September 2020 at 3 medical centers in China. Patients with cirrhotic ascites were randomly assigned to receive rHA or HSA at 10 g/day, 20 g/day, or 30 g/day. Each group had 12 participants (nine receiving rHA and three receiving HSA as positive control). Treatment lasted up to 14 days or until serum albumin levels reached 35 g/L, followed by a 28-day follow-up. Adverse events monitored assessed saHepatology internationalA randomized, phase Ib trial of recombinant human serum albumin in cirrhotic patients with ascites.PMC129234782017TD-0881970519Wen XHu YGuo XWang CFu ZYu GPiao HWang SQi YNiu JWang XWang YJin JWang ZPan YJin QJi HZhou QKong FXu FHua RXin GLi WGao RLi XPiao ZGao YCai YXiang WYang TfalseA randomized, phase Ib trial of recombinant human serum albumin in cirrhotic patients with ascites.<h4>Background</h4>Recombinant human serum albumin (rHA) is a promising alternative to human serum albumin (HSA) for managing ascites in cirrhotic patients. This phase Ib study aims to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) profiles of rHA in this population.<h4>Methods</h4>This randomized, open-label, phase Ib trial was conducted between December 2019 and September 2020 at 3 medical centers in China. Patients with cirrhotic ascites were randomly assigned to receive rHA or HSA at 10 g/day, 20 g/day, or 30 g/day. Each group had 12 participants (nine receiving rHA and three receiving HSA as positive control). Treatment lasted up to 14 days or until serum albumin levels reached 35 g/L, followed by a 28-day follow-up. Adverse events monitored assessed sa2026-01-01T00:00:00Z2026 Feb2026-07-16T15:14:49.294Z2026-07-10T03:09:48.014ZS-EPMC129234784069952210.1007/s12072-025-10871-x