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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-hepatectomy Hypoalbuminemia
• Intervention / Treatment: Drug: Rice-derived recombinant human serum albumin (OsrHSA)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Qi Cheng, M.D.; Phone Number: 13871459541; Email: chengqi@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Qi Cheng, M.D.; Phone Number: 13871459541; Email: chengqi@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment group; Patients receive daily intravenous infusion of 20 g rice-derived recombinant human serum albumin (OsrHSA, 20%, 50 mL) starting from the day when postoperative hypoalbuminemia (<30 g/L) is identified.

Drug: Rice-derived recombinant human serum albumin (OsrHSA); All trial participants will receive daily intravenous infusion of 20 g Rice-derived recombinant human serum albumin (OsrHSA, 20%, 50 mL) starting from the day when postoperative hypoalbuminemia is identified, for a maximum duration of 7 days, with concurrent monitoring of serum albumin levels. Study drug administration will be discontinued once serum albumin reaches ≥35 g/L, and participants will enter the follow-up period. Each trial participant will undergo one follow-up visit within 30 days after treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage of trial participants achieving serum albumin ≥35 g/L within one week	one week after administrating rice-derived recombinant human serum albumin

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to serum albumin ≥35 g/L (days)	one week after administrating rice-derived recombinant human serum albumin
adverse event	30 days after administrating rice-derived recombinant human serum albumin

Collaborators and Investigators

• Sponsor: Cheng Qi

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): July 7, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HY1001-2026-IIT-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No