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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
A randomized, phase Ib trial of recombinant human serum albumin in cirrhotic patients with ascites
Xinrui Wang1,2,3, Wanyu Li1,2,3, Fei Kong1,2,3
1Department of Hepatology, Center of Infectious Diseases and Pathogen Biology, The First Hospital of Jilin University, Changchun, 130021, China.
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.
