Trial reportSignal transduction and targeted therapy2026
A randomized, double-blind, active-controlled phase 3 multicenter trial of rHSA for cirrhotic ascites.
Trial report in Signal transduction and targeted therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06553456 (Random, Double-blind, Parallel Group Phase II/III Clinical Trial to Evaluate the Effectiveness and Safety of Recombinant Human Serum Albumin Versus Human Serum Albumin in Hepatic Cirrhosis Patients With Ascites), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Random, Double-blind, Parallel Group Phase II/III Clinical Trial to Evaluate the Effectiveness and Safety of Recombinant Human Serum Albumin Versus Human Serum Albumin in Hepatic Cirrhosis Patients With Ascites
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
72 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In this multicenter, randomized, double-blind, active-controlled phase 3 trial (NCT06553456), we assessed the equivalence of recombinant human serum albumin (rHSA) expressed in Pichia pastoris to plasma-derived human serum albumin (pHSA) for elevating serum albumin (ALB) levels and non-inferiority regarding ascites improvement in patients with cirrhotic ascites. Using a rigorous dual-endpoint design, the primary endpoint was the change from baseline in serum ALB immediately after the final intravenous infusion. The key secondary endpoint was the ascites improvement rate after the final administration. Ultimately, 364 out of 390 patients completed the study. Statistical equivalence was established for the primary endpoint, with least-squares mean ALB changes of 11.16 ± 0.364 g/L (rHSA) and 10.95 ± 0.395 g/L (pHSA) (LSM difference: 0.21 g/L [95% CI: -0.75, 1.16]). For the secondary endpoint, ascites improvement was non-inferior, demonstrating a 58.0% response rate for rHSA versus 48.7% for pHSA (difference: 9.4% [95% CI: -0.56%, 19.10%]). Both endpoints of the trial were successfully achieved. The overall incidence of adverse events was similar in the two groups; crucially, no anti-drug antibodies were detected in the rHSA group. Exploratory analysis revealed that rHSA significantly reduced glycated ALB (-12.24%), whereas pHSA increased it ( + 12.52%) (P < 0.001). Corroborated by LC‒MS characterization, silver-staining purity assessment, and four biochemical quality attributes (free thiol, Hcy, AGEs, and carbonyl levels), this divergence highlights the preserved molecular integrity of rHSA. This trial demonstrated that in patients with cirrhotic ascites, rHSA was statistically equivalent to pHSA in elevating serum ALB and non-inferior in ascites improvement, with a favorable safety profile.
Indexed as
Identifiers
What Socratic holds
Registered trials
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 Socratic graph.