Testing OsrHSA for patients with cirrhotic ascites

A Phase II, Multicenter, Randomized, Positive-Controlled, and Multi-Cohort Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites

This study is testing whether a new treatment called OsrHSA can help people with cirrhotic ascites feel better compared to a standard treatment, human serum albumin.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Healthgen Biotechnology Corp. (industry)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT04835480 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy of intravenous OsrHSA compared to a positive control, human serum albumin (HSA), in patients with decompensated cirrhotic ascites. Participants will be randomized in a 4:1 ratio to receive either OsrHSA or HSA for 14 days, with assessments for efficacy, safety, tolerability, and immunogenicity. The study includes a screening period of up to 14 days and follow-up visits over two weeks. Treatment assignment will be blinded to both the investigator and subjects, and participants will be stratified based on their baseline serum albumin levels.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with decompensated cirrhosis and serum albumin levels of 30 g/L or lower.

Not a fit: Patients with compensated cirrhosis or those with serum albumin levels above 30 g/L may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients suffering from decompensated cirrhotic ascites.

How similar studies have performed: Other studies have explored similar interventions, but the specific use of OsrHSA in this context is novel.

Eligibility criteria

Inclusion Criteria:

1. Able to understand and willing to sign the ICF;
2. Decompensated cirrhosis with ascites by clinical, laboratory, or imaging evidence. Male or female eligible; Age ≥18 years and ≤80 years;
3. Serum albumin ≤30 g/L;
4. Has adequate venous access;
5. 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:

     * 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.

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, i.e. anti-rice Ig E ≥ 0.35 kU/L and anti-rice Ig G ≥ 25.0 mgA/L;
3. 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);
4. 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);
5. Malignant ascites or ascites caused by cancer embolus;
6. Subjects with Grade C or D liver cancer according to the Barcelona-Clinic Liver Cancer staging (See Appendix 6);
7. Pregnancy;
8. HIV positive;
9. Active obstructive disease in the biliary tract defined by ultrasound or other imaging modalities;
10. 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+;
11. Subjects with Stage C or D heart failure according to ACCF/AHA Stage (See Appendix 7);
12. Previous transplant;
13. The mental state that prevents the subject from understanding the nature, extent, and consequences of the study;
14. Any clinical condition that the Investigator considers would make the subject unsuitable for the trial.

Where this trial is running

Changchun, Jilin

• First Hospital of Jilin University — Changchun, Jilin, China (RECRUITING)

Study contacts

• Study coordinator: Healthgen Wuhan

Conditions: Cirrhotic Ascites