Actively Recruiting
A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites
Led by Healthgen Biotechnology Corp. · Updated on 2021-11-19
220
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign the informed consent form
- Diagnosis of decompensated cirrhosis with ascites confirmed by clinical, laboratory, or imaging evidence
- Male or female aged 18 to 80 years
- Serum albumin level of 30 g/L or lower
- Adequate venous access available
- Female participants must be either non-childbearing or agree to use effective contraception and have a negative pregnancy test at screening
- Male participants who are sexually active with non-sterile female partners must agree to use double contraception methods and not donate sperm during the study
You will not qualify if you...
- Known allergy or severe reaction to cereals or any food containing cereals, including rice
- Positive tests for IgE or IgG antibodies against rice
- Medical conditions requiring albumin use other than hepatic cirrhosis, such as paracentesis-induced circulatory dysfunction or large-volume paracentesis
- Nephrotic syndrome, hepatorenal syndrome, or creatinine levels above twice the upper limit of normal
- Significant heart or lung disease, hemodialysis, active upper gastrointestinal bleeding, or severe hepatic encephalopathy
- Malignant ascites or ascites caused by cancer embolus
- Advanced liver cancer (Grade C or D according to specified staging)
- Pregnancy
- HIV positive status
- Active obstructive biliary tract disease
- Abnormal laboratory values including low neutrophils, platelets, white blood cells, hemoglobin, or elevated liver enzymes, bilirubin, clotting times, or urine protein
- Advanced heart failure (Stage C or D)
- Previous organ transplant
- Mental state preventing understanding of study details
- Any condition deemed unsuitable for the trial by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
Research Team
H
Healthgen Wuhan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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