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

ConditionCirrhotic Ascites

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorHealthgen Biotechnology Corp.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to understand and willing to sign the ICF;

Decompensated cirrhosis with ascites by clinical, laboratory, or imaging evidence. Male or female eligible; Age ≥18 years and ≤80 years;

Serum albumin ≤30 g/L;

Has adequate venous access;

Disqualifiers

Previous known allergic/adverse reaction to cereal or any food containing cereal, including rice; A history of a severe allergic reaction to any HpHSA component or any food;

Positive IgE and IgG against rice at the screening, i.e. anti-rice Ig E ≥ 0.35 kU/L and anti-rice Ig G ≥ 25.0 mgA/L;

Subjects who have medical conditions except for hepatic cirrhosis, currently requiring the use of albumin such as paracentesis-induced circulatory dysfunction, large- volume paracentesis (>5 L each time);

Nephrotic syndrome, hepatorenal syndrome or Creatinine >2 × upper limit of normal (ULN), significant cardiopulmonary or structural heart disease, hemodialysis, active upper gastrointestinal bleeding, subjects with hepatic encephalopathy Grade III or IV (see Appendix 5 for hepatic encephalopathy stages);

Trial design

Design model

Parallel

Treatments tested in this trial

OrsHSA
Drug
OsrHSA a recombinant HSA, which was expressed and purified from the plant Oryza sativa
HSA
Drug
Albutein® 20% (ALBUMIN HUMAN INFUSION 20% 50ML)

Treatment groups

220 Participants

are divided into 2 treatment groups

Group A: OsrHSA GroupExperimental treatment 1 intervention

Group B: HSA Group1Active comparator 1 intervention

Trial outcomes

Primary outcomes

OrsHSA exhibits good efficacy by rescue serum albumin levels.

A relatively high percentage of subjects whose serum albumin reaches 35 g/L or more at any time up to 14 days by using OsrHSA.

Time frame

14 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Healthgen Biotechnology Corp.

Lead sponsor

Source ClinicalTrials.gov

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