Phase II Study of Intravenous OsrHSA Compared to Human Serum Albumin in Adults With Decompensated Cirrhotic Ascites

What this Trial Is About

Researchers are evaluating the efficacy of intravenous OsrHSA compared to a positive control human serum albumin HSA in patients with decompensated cirrhotic ascites. This Phase II, multicenter, randomized, double-blind study aims to assess how well OsrHSA raises serum albumin levels and its safety and tolerability over a 14-day treatment period. Participants are stratified based on their baseline serum albumin levels to guide treatment continuation. Participants are randomly assigned in a 41 ratio to receive either OsrHSA or the positive control HSA at doses of 10 g or 20 g once daily via intravenous infusion for 14 days. The study includes multiple cohorts receiving these doses, with blinding maintained for both investigators and participants. Treatment may be stopped early if serum albumin levels reach 35 gL or higher. After treatment, participants undergo three follow-up visits over two weeks to monitor progress. During the study, participants will be regularly evaluated for efficacy, safety, tolerability, and immune response to the treatments. Researchers will measure serum albumin levels to determine treatment effectiveness. The total participation duration includes up to 14 days of screening, 14 days of treatment, and follow-up visits over two weeks. The study tracks laboratory tests, clinical assessments, and adverse events to support comprehensive monitoring throughout the trial.

A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites