A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoa… (NCT06355479) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia
China328 participantsStarted 2023-04-10
Plain-language summary
The goal of this clinical trial is to evaluate the efficacy of OsrHSA works to treat hypoalbuminemia in hepatic cirrhosis patients. It will also learn about the safety and immunogenicity of OsrHSA. The main question it aims to answer is whether OsrHSA is effective in elevating the serum albumin level of cirrhotic patients with hypoalbuminemia.
Researchers will compare OsrHSA to the positive comparator, plasma-derived HSA (pHSA) to see if OsrHSA presents as non-inferior to pHSA in the indication of hypoalbuminemia in hepatic cirrhosis patients.
Participants will be randomized in a 1:1 ratio to receive OsrHSA or HpHSA (20g IV qd) for up to 14 days, following an EOT visit. Follow-up visits will be taken on EOT+7d, EOT+14d, and EOT+30d, respectively.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Diagnosis of hepatic cirrhosis
✓. Adult males or females, aged 18-75 years (both inclusive) at the time of consent
✓. Serum albumin level ≤ 30 g/L
✓. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol
Exclusion criteria
✕. History of allergy to rice; a history of allergy to any component of the HpHSA product
✕. Therapeutic/ Large-volume paracentesis (\> 5L each time) during the treatment period
✕. Ascites resulted from non-hepatic cirrhosis, Budd-Chiari syndrome
✕. Participants with Grade III or Grade IV hepatic encephalopathy using West Heaven Criteria
✕. A transjugular intrahepatic peritoneal shunt (TIPS) is performed within 1 month prior to the first dosing
What they're measuring
1
To evaluate the efficacy of OsrHSA on elevating the serum albumin level.