Cirrhotic AscitesPhase 2NCT04835480
A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites
A Phase 2 study testing OrsHSA and HSA in people with Cirrhotic Ascites, run by Healthgen Biotechnology Corp. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhotic Ascites
- What is being tested?
- OrsHSA and HSA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2021to 30 Jun 2022
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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:
- simultaneous use of the intrauterine contraceptive device, placed at least 4 weeks prior to study drug administration, and condom for the male partner;
- simultaneous use of hormonal contraceptives, starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner;
- simultaneous use of a diaphragm with intravaginally applied spermicide and male condoms for the male partner, starting at least 21 days prior to study drug administration.
- 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:
- simultaneous use of a male condom and, for the female partner, hormonal contraceptives (used since at least 4 weeks) or intrauterine contraceptive device (placed since at least 4 weeks);
- simultaneous use of a male condom and, for the female partner, a diaphragm with intravaginally applied spermicide.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin
Xinrui Wang, MD, +86 431 85612437
About this study
Official title: A Phase II, Multicenter, Randomized, Positive-Controlled, and Multi-Cohort 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.
- Conditions
- Cirrhotic Ascites
- Being tested
- OrsHSA, HSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrsHSADrug
OsrHSA a recombinant HSA, which was expressed and purified from the plant Oryza sativa
HSADrug
Albutein® 20% (ALBUMIN HUMAN INFUSION 20% 50ML)
| Study group | Role | What they receive |
|---|---|---|
| OsrHSA Group | Experimental | OsrHSA (10g or 20g), IV, qd Receives: Drug: OrsHSA |
| HSA Group1 | Active comparator | HSA (10g or 20g), IV, qd Receives: Drug: HSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start22 Mar 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhotic AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthgen Biotechnology Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835480
- Sponsor's protocol ID
- US-China-HY1001
- Status last verified
- Apr 2021
- First submitted
- 5 Apr 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40555465
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Positive-Controlled, and Multi-Cohort Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites
- ClinicalTrials.gov ID
- NCT04835480
- Acronym / sponsor ID
- US-China-HY1001
- Conditions
- Cirrhotic Ascites
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Healthgen Biotechnology Corp.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OsrHSA Group | Experimental | Drug: OrsHSAOsrHSA (10g or 20g), IV, qd |
| HSA Group1 | Active comparator | Drug: HSAHSA (10g or 20g), IV, qd |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrsHSAOsrHSA a recombinant HSA, which was expressed and purified from the plant Oryza sativa | Drug | OsrHSA Group |
| HSAAlbutein® 20% (ALBUMIN HUMAN INFUSION 20% 50ML) | Drug | HSA Group1 |
Primary outcome
OrsHSA exhibits good efficacy by rescue serum albumin levels.
Time frame: 14 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Derived from this study: PubMed 40555465Niu 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OrsHSA and HSA in people with Cirrhotic Ascites, run by Healthgen Biotechnology Corp. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Healthgen Wuhan (+86 27 59403931, info@oryzogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OrsHSA exhibits good efficacy by rescue serum albumin levels. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04835480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.