Rice-Based protein could replace plasma for Post-Surgery patients
NCT ID NCT07634549
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a lab-made human albumin protein grown in rice to treat low albumin levels after liver surgery. About 50 adults who have had part of their liver removed and developed low albumin will receive daily infusions of this protein for up to a week. The goal is to see if it safely raises albumin levels back to normal, offering an alternative to plasma-derived albumin that avoids supply shortages and infection risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430030, China