- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04835480
A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites
A Phase II, Multicenter, Randomized, Positive-Controlled, and Multi-Cohort Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Healthgen Wuhan
- Phone Number: +86 27 59403931
- Email: info@oryzogen.com
Study Locations
-
-
Jilin
-
Changchun, Jilin, China
- Recruiting
- First Hospital of Jilin University
-
Contact:
- Xinrui Wang, MD
- Phone Number: +86 431 85612437
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OsrHSA Group
OsrHSA (10g or 20g), IV, qd
|
OsrHSA a recombinant HSA, which was expressed and purified from the plant Oryza sativa
|
Active Comparator: HSA Group1
HSA (10g or 20g), IV, qd
|
Albutein® 20% (ALBUMIN HUMAN INFUSION 20% 50ML)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
14 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- US-China-HY1001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cirrhotic Ascites
-
MovetisCompleted
-
Dalia Nasser MohamedRecruitingCirrhotic Ascitic PatientsEgypt
-
Korea Otsuka Pharmaceutical Co., Ltd.TerminatedHyponatremia and Extracellular Fluid in CirrhoticKorea, Republic of
-
Centre Hospitalier Universitaire de BesanconUnknownCirrhotic Patients With AscitesFrance
-
Assistance Publique - Hôpitaux de ParisActive, not recruitingIntrahepatic Non Cirrhotic Portal HypertensionFrance
-
Postgraduate Institute of Medical Education and...UnknownRefractory Ascites
-
University of AlbertaBecton, Dickinson and CompanyCompleted
-
Eastern Regional Medical CenterTerminatedMalignant AscitesUnited States
-
Mansoura UniversityCompleted
-
NovaShunt AGCompletedRefractory AscitesCzech Republic