A Phase II Study of OsrHSA Compared to Albumin
in Patients With Decompensated Cirrhotic Ascites
Randomized, Double-Blind, Multicenter Trial
Led by Healthgen Biotechnology Corp. · Updated on 2021-11-19
220
Participants Needed
1
Research Sites
66 weeks
Total Duration
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Research Team
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AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of intravenous OsrHSA, a recombinant human serum albumin derived from rice plants, compared to a positive control human serum albumin in patients with decompensated cirrhosis and ascites. The study is a Phase II, multicenter, randomized, positive-controlled trial involving adults aged 18 to 80 years with low serum albumin levels. Participants are divided into groups based on their initial serum albumin levels to assess the treatment impact.
Participants receive daily intravenous doses of either OsrHSA or the control albumin for 14 days. Subjects are randomly assigned in a 4:1 ratio to receive OsrHSA or the control albumin, with both investigators and patients blinded to the treatment group. If a participant's serum albumin rises to 35 g/L or higher, the treatment may be stopped early. After treatment, participants attend three follow-up visits over two weeks.
During the study, patients are monitored for effectiveness, safety, tolerance, and immune response to the treatments. Researchers measure serum albumin levels as the primary indicator of effectiveness. The total participation involves a screening period of up to 14 days, a 14-day treatment phase, and a two-week follow-up period, with evaluations throughout to monitor health status and treatment response.
CONDITIONS
Official Title
A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites
Who Can Participate
Age: 18Years - 80Years
All Genders
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
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1
2
3
Trial Site Locations
Total: 1 location
1
First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
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Research Team
H
Healthgen Wuhan
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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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.
