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

ABSTRACT:

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 sa

SUBMITTER: Wang X 

PROVIDER: S-EPMC12923478 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature