Cirrhotic Ascites

1

Review clinical trials related to Cirrhotic Ascites. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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

The study is designed to study the efficacy of IV OsrHSA or positive control HSA (10 g and 20 g IV everyday) for 14 days. After a screening period of up to 14 days, the eligible subjects will be randomized in a 4:1 ratio to OsrHSA and positive control HSA, respectively, in each cohort. Each enrolled subject will receive multiple assigned doses of OsrHSA. The Investigator and subjects will be blind to treatment assignment (OsrHSA or positive control HSA) in each cohort. During the study, subjects will be evaluated for efficacy, safety, tolerability, and immunogenicity. In each cohort, subjects will be stratified by baseline serum albumin level. If serum albumin reaches 35 g/L or more, the study drug or control drug administration may be terminated early. Subjects will have 3 follow-up visits in 2 weeks.

Participants needed: 220
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: Healthgen Biotechnology Corp.Updated: Nov 19, 2021Locations: 1
Eligibility criteria

Able to understand and willing to sign the ICF; [+9]

Previous known allergic/adverse reaction to cereal or any food containing cereal... [+12]