Rice-derived Recombinant Human Serum Albumin for the Treatment of Hypoalbuminemia After Hepatecto… (NCT07634549) | Clinical Trial Compass
RecruitingPhase 4
Rice-derived Recombinant Human Serum Albumin for the Treatment of Hypoalbuminemia After Hepatectomy: A Prospective, Single-Arm, Exploratory Clinical Trial
China50 participantsStarted 2026-06-15
Plain-language summary
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 hypoalbuminemia after hepatectomy. All trial participants will receive daily intravenous infusion of 20 g OsrHSA (20%, 50 mL) starting from the day when postoperative hypoalbuminemia (\<30 g/L) is identified, with concurrent monitoring of serum albumin levels. The primary endpoints are the percentage of trial participants achieving serum albumin ≥35 g/L within one week, and the incidence of adverse drug reactions.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Able to understand and willing to sign the informed consent form.
* Male or female; age ≥18 years and ≤80 years.
* Planned for or has undergone hepatectomy.
* Developed postoperative hypoalbuminemia, defined as serum albumin ≤30 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The percentage of trial participants achieving serum albumin ≥35 g/L within one week
Timeframe: one week after administrating rice-derived recombinant human serum albumin