Recombinant Albumin in Cirrhosis: Can We Move Beyond Donor Plasma?: Signal Transduction and Targeted Therapy | September 2026

What Did the Study Find?

This phase III trial randomized 390 patients with cirrhotic ascites and hypoalbuminemia to recombinant human serum albumin (rHSA) or conventional plasma-derived albumin.

Both treatments were administered at 20 g/day for 7 days.

Serum albumin increased similarly: 11.16 vs 10.95 g/L, meeting equivalence criteria.

Ascites improved in 58.0% with rHSA vs 48.7% with plasma-derived albumin, meeting prespecified noninferiority.

Overall adverse-event rates were similar between groups.

Importantly, no anti-rHSA antibodies were detected.

The trial establishes short-term therapeutic equivalence—not superiority or survival benefit.

Participants were exclusively Asian and predominantly had HBV-related cirrhosis, limiting broader generalizability.

Why Does It Matter?

Albumin therapy currently depends on donated human plasma, creating potential constraints in supply, scalability and manufacturing capacity.

GastroAGI Takeaway

The potential breakthrough is in supply, not greater efficacy. Recombinant albumin performed comparably to plasma-derived albumin for short-term treatment of cirrhotic ascites. If broader studies confirm these findings and regulatory approval follows, rHSA could provide a scalable, non-plasma alternative to conventional human albumin.