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

Обзор

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.

Вмешательства

• Препарат 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 a

Первичные конечные точки

• The percentage of trial participants achieving serum albumin ≥35 g/L within one week [Срок оценки: one week after administrating rice-derived recombinant human serum albumin]

Вторичные конечные точки (2)

• Time to serum albumin ≥35 g/L (days) [Срок оценки: one week after administrating rice-derived recombinant human serum albumin]
• adverse event [Срок оценки: 30 days after administrating rice-derived recombinant human serum albumin]

Критерии участия

Критерии включения

• 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 .

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT07634549 · HY1001-2026-IIT-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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