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Background <p>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.</p> Methods <p>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&#xa0;g/day, 20&#xa0;g/day, or 30&#xa0;g/day. Each group had 12 participants (nine receiving rHA and three receiving HSA as positive control). Treatment lasted up to 14&#xa0;days or until serum albumin levels reached 35&#xa0;g/L, followed by a 28-day follow-up. Adverse events monitored assessed safety and tolerability, while PK/PD was evaluated by tracking serum albumin levels and plasma colloid osmotic pressure (PCOP) before and after each dose (ClinicalTrials.gov No. NCT04701697).</p> Results <p>Thirty-six Chinese participants were enrolled, with 32 completing the study. The incidence of adverse events was similar between the rHA and HSA groups (44.4% vs. 44.4%, <i>p</i> &gt; 0.05). Serum albumin concentration increases were comparable between groups during treatment and follow-up. While most participants experienced weight and abdominal circumference decreases, no significant dose effect was observed (<i>p</i> &gt; 0.05). No anti-drug antibodies were detected.</p> Conclusion <p>In this study, rHA demonstrated similar safety and PK/PD to HSA in cirrhotic patients with ascites. rHA was well-tolerated, supporting the need to evaluate its safety and efficacy in a phase II clinical study.</p>

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A randomized, phase Ib trial of recombinant human serum albumin in cirrhotic patients with ascites

  • 期刊论文

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  • 发表日期：

    2025年7月23日

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  • Xinrui Wang,
  • Wanyu Li,
  • Fei Kong,
  • Xiaolin Guo,
  • Qinglong Jin,
  • Runping Gao,
  • Yulin Hu,
  • Yanjun Cai,
  • Guijie Xin,
  • Huifan Ji,
  • Hongxin Piao,
  • Zhaoxu Fu,
  • Yifei Wang,
  • Zhiyong Piao,
  • Siqi Wang,
  • Rui Hua,
  • Xiaoyu Wen,
  • Yue Qi,
  • Jinglan Jin,
  • Chong Wang,
  • Zhongfeng Wang,
  • Fang Xu,
  • Qiang Zhou,
  • Xu Li,
  • Ge Yu,
  • Yang Wang,
  • Tao Yang,
  • Wei Xiang,
  • Yu Pan,
  • Junqi Niu,
  • Yanhang Gao

摘要

Background

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.

Methods

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 safety and tolerability, while PK/PD was evaluated by tracking serum albumin levels and plasma colloid osmotic pressure (PCOP) before and after each dose (ClinicalTrials.gov No. NCT04701697).

Results

Thirty-six Chinese participants were enrolled, with 32 completing the study. The incidence of adverse events was similar between the rHA and HSA groups (44.4% vs. 44.4%, p > 0.05). Serum albumin concentration increases were comparable between groups during treatment and follow-up. While most participants experienced weight and abdominal circumference decreases, no significant dose effect was observed (p > 0.05). No anti-drug antibodies were detected.

Conclusion

In this study, rHA demonstrated similar safety and PK/PD to HSA in cirrhotic patients with ascites. rHA was well-tolerated, supporting the need to evaluate its safety and efficacy in a phase II clinical study.