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Rice-derived Recombinant Human Serum Albumin for the Treatment of Hypoalbuminemia After Hepatectomy: A Prospective, Single-Arm, Exploratory Clinical Trial

RecruitingPhase 4Ages 18 Years - 80 YearsAllCheng Qi
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In plain words

What the trial is, and whether it could suit you

Rice-derived recombinant human serum albumin (OsrHSA) possesses an identical primary, secondary, and higher-order structure to plasma-derived human albumin. Through innovative production technology, it fundamentally circumvents the supply limitations and viral contamination risks associated with plasma sources, offering a novel solution to address clinical unmet needs. Existing research data have demonstrated that its efficacy and safety are non-inferior to plasma-derived human albumin in patients with cirrhosis complicated by hypoalbuminemia. However, no study has yet explored the safety and efficacy of OsrHSA in patients with postoperative hypoalbuminemia following hepatectomy. This study is a prospective, single-arm, small-sample, exploratory clinical trial aimed at evaluating the efficacy and safety of recombinant human serum albumin injection (rice) (OsrHSA) in patients with hypoalb

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Able to understand and willing to sign the informed consent form. * Male or female; age โ‰ฅ18 years and โ‰ค80 years. * Planned for or has undergone hepatectomy. * Developed postoperative hypoalbuminemia, defined as serum albumin โ‰ค30 g/L . Exclusion Criteria: * Known hypersensitivity to the active ingredient or any excipient of the investigational drug * Complicated with any of the following diseases or conditions: severe renal disease requiring hemodialysis, active upper gastrointestinal bleeding, hepatic encephalopathy Grade III or IV. * Pregnant or lactating women. * HIV positive. * Heart failure classified as Stage C or D according to ACCF/AHA criteria. * History of organ transplantation. * Mental status that prevents the participant from understanding the nature, scope, and consequences of the study. * Any clinical condition that the investigator considers makes the trial participant unsuitable for participation in the trial.
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What it tests

  • Rice-derived recombinant human serum albumin (OsrHSA)
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Where

1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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