Trial reportGut2025
Rice-derived recombinant human serum albumin as an alternative to human plasma for patients with decompensated liver cirrhosis: a randomised, double-blind, positive-controlled and non-inferiority trial.
Trial report in Gut, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04835480 (A Phase II, Multicenter, Randomized, Positive-Controlled, and Multi-Cohort Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites), which is not on this map. Cited by 4 papers.
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.
A Phase II, Multicenter, Randomized, Positive-Controlled, and Multi-Cohort Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites
Who cites it
4 citing papers 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
- Encapsulation of Protein-Based Drug Carriers for Controlled Loading and Releasing Efficiency: A Review.The protein journal · 2026Review
- Metabolic Rewiring of the Shikimate Pathway Enables Rose-Scented Rice.Plant biotechnology journal · 2026Article
- A Pichia pastoris-based platform for large-scale production of functional recombinant human serum albumin with therapeutic efficacy.Bioprocess and biosystems engineering · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
29 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDespite inadequate supply and potential contamination risk, human plasma has remained the only source for human serum albumin (pHSA) intravenous administration since the 1940s.
objectiveWe sought to establish the safety and efficacy of OsrHSA, a recombinant HSA from bioengineered
designIn this multicentre, randomised, double-blind and positive-controlled study, patients with decompensated liver cirrhosis and serum albumin ≤30 g/L were recruited from 22 centres in China. The patients were randomly assigned to OsrHSA or pHSA (4:1) to once-daily intravenous injection (10 g or 20 g) until their serum albumin level reached 35 g/L, for a maximum of 2 weeks, with 2 weeks of follow-up. The primary outcome was the proportion of patients to reach a serum albumin level of 35 g/L (non-inferiority margin <-0.20). Outcomes were evaluated in patients who received the study drug and had at least one post-baseline serum albumin value (full analysis set, FAS). Safety was evaluated in all patients who received the study drug.
resultsBetween 22 March 2021 and 2 June 2022, 220 patients received OsrHSA (n=175) or pHSA (n=45). 216 patients were included in the FAS (OsrHSA, n=171; pHSA, n=45). Primary outcome of OsrHSA (130/171, 76%) was non-inferior to pHSA (34/45, 75.6%) (difference=0.5%; lower limit of 97.5% CI=-0.119). There was no significant difference between all secondary outcomes of OsrHSA and pHSA. There were no drug-related serious adverse events.
conclusionsRice-derived HSA is non-inferior to plasma-derived HSA in efficacy and safety. This finding should be confirmed in phase 3 trial. TRIAL REGISTRATION NUMBER: NCT04835480.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.