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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OsrHSA Group | Experimental | OsrHSA (10g or 20g), IV, qd |
|
| HSA Group1 | Active Comparator | HSA (10g or 20g), IV, qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OrsHSA | Drug | OsrHSA a recombinant HSA, which was expressed and purified from the plant Oryza sativa |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
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Inclusion Criteria:
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;
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:
Practicing abstinence;
If a sexually active woman of childbearing potential (sexually active with a non-sterile male partner) agrees to prevent pregnancy by using double methods of contraception as follow until at least 90 days after the administration of the investigational product:
Male subjects who are not vasectomized for at least 6 months and who are sexually active with a non-sterile female partner must agree to use double methods of contraception below from the first dose of randomized study drug until 90 days after their dose and must not donate sperm during their study participation period:
Exclusion Criteria:
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);
Malignant ascites or ascites caused by cancer embolus;
Subjects with Grade C or D liver cancer according to the Barcelona-Clinic Liver Cancer staging (See Appendix 6);
Pregnancy;
HIV positive;
Active obstructive disease in the biliary tract defined by ultrasound or other imaging modalities;
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 > 5.0 ×ULN; PT INR > 2.0; Urine protein > 2+;
Subjects with Stage C or D heart failure according to ACCF/AHA Stage (See Appendix 7);
Previous transplant;
The mental state that prevents the subject from understanding the nature, extent, and consequences of the study;
Any clinical condition that the Investigator considers would make the subject unsuitable for the trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Healthgen Wuhan | Contact | +86 27 59403931 | info@oryzogen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40555465 | Derived | Niu J, Gao Y, Wang G, Qin Z, Wu C, Yu Z, Wang L, Hu Z, Li X, Zhang Z, Chen Y, Yao L, Yang J, Li GM, Yang Y, Lu X, Gu Y, Wu X, Mao X, Zhou Z, Shang J, Lin B, Jia JD, Wang F, Zhang J, Ma H, Wang X, Yang CY, Yang D. Rice-derived recombinant human serum albumin as an alternative to human plasma for patients with decompensated liver cirrhosis: a randomised, double-blind, positive-controlled and non-inferiority trial. Gut. 2025 Aug 7;74(9):1476-1485. doi: 10.1136/gutjnl-2025-335577. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 16, 2023 | Jun 12, 2023 | 2 | ||
| Jun 15, 2023 |
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| HSA | Drug | Albutein® 20% (ALBUMIN HUMAN INFUSION 20% 50ML) |
|
| Jul 10, 2023 |
| 3 |
| Jul 18, 2023 | Jul 31, 2023 | 4 |