Trial reportHepatology international2026
A randomized, phase Ib trial of recombinant human serum albumin in cirrhotic patients with ascites.
Trial report in Hepatology international, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04701697 (Phase Ib Study of Recombinant Human Albumin Injection for the Treatment of Ascites in Patients With Hepatic Cirrhosis), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase Ib Study of Recombinant Human Albumin Injection for the Treatment of Ascites in Patients With Hepatic Cirrhosis
Who cites it
1 citing paper in PubMed.
- Phase I Study Evaluating Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Recombinant Human Serum Albumin (rHSA) in Healthy Adults.Drug design, development and therapy · 2026Trial
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Authors and funding
31 authors.
Funding
Abstract
backgroundRecombinant 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.
methodsThis 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).
resultsThirty-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.
conclusionIn 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.
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