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

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Healthgen Biotechnology Corp.

Criteria

Inclusion Criteria:

1. Able to understand and willing to sign the ICF;

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

3. Serum albumin ≤30 g/L;

4. Subjects not requiring frequent large-volume paracentesis, defined by more than 1/month;

5. Has adequate venous access;

6. Be a female of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal and has a follicle stimulating hormone > 40mIU/mL, or surgically sterile [defined as having a bilateral oophorectomy, hysterectomy or tubal ligation]) or a woman of childbearing potential who agrees to one of the following to prevent pregnancy and has a negative serum pregnancy test at screening

Exclusion Criteria:

1. 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;

2. Positive IgE and IgG against rice at the screening;

3. Subjects who have medical conditions currently requiring the use of albumins such as paracentesis induced circulatory dysfunction, active spontaneous bacterial peritonitis, large-volume paracentesis (>5 L each time), hepatorenal syndrome or Creatinine >2 × upper limits of normal (ULN);

4. Nephrotic syndrome, significant cardiopulmonary or structural heart disease/chronic kidney diseases with glomerular filtration rate <30 ml/min/hemodialysis/active upper gastrointestinal bleeding; subjects with hepatic encephalopathy Grade III or IV;

5. Malignant ascites or ascites caused by cancer embolus;

6. Subjects with Grade III or IV liver cancer according to the Barcelona-Clinic Liver Cancer staging;

7. Pregnancy;

8. HIV positive;

9. Uncontrolled systemic disease, including infection;

10. Active obstructive disease in the biliary tract defined by ultrasound or other imaging modalities;

11. With the following abnormal laboratory test values:

Absolute neutrophil count (NE#) <1.0 × 109/L, platelets <30 × 109/L, white blood cells<2.0 × 109/L, hemoglobin <75 g/L; ALT and (or) AST >5 × ULN, total bilirubin > 3.0 ×ULN; INR > 1.5; PRO > 2+

12. Heart failure or structural heart disease. Cardiac function: cardiac output by the person's body surface area <2.0L/min/m2 (normal range is 2.5-4.0 L/min/m2) or left ventricular ejection fraction (LVEF) <50% (moderately abnormal); severe lung and cardiac disease;

13. Previous transplant;

14. The mental state that prevents the subject from understanding the nature, extent, and consequences of the study;

15. Any clinical condition that the Investigator considers would make the subject unsuitable for the trial.