Lab-Made albumin could replace donor protein for liver patients

NCT ID NCT06553456

Disease control Sponsor: Protgen Ltd Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a lab-made version of a blood protein (recombinant human serum albumin) works as well as the natural version for treating fluid buildup in the belly (ascites) caused by severe liver disease. 390 adults with liver cirrhosis and ascites took part. The goal was to see if the lab-made protein can safely raise blood protein levels and reduce fluid buildup.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

390 people

The number who actually took part.

Started

Aug 2024

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Agree to follow the experimental treatment plan and visit schedule, voluntarily join the group, and sign a written informed consent form; 2. On the day of signing the informed consent form, the age is between 18 and 70 years old, and there is no gender limit; Body mass index (BMI) within the range of 17.0-29.0 kg/m² (including boundary values); 3. Patients diagnosed clinically with decompensated liver cirrhosis ascites, and confirmed by abdominal ultrasound examination during screening to have ascites grading of 1-2, while meeting the requirement of serum albumin (ALB)\<30 g/L; 4. Men with fertility and women of childbearing age (women of childbearing age include premenopausal women and women within two years after menopause) are willing to take effective contraceptive measures (condoms, contraceptive sponges, contraceptive gel, contraceptive membranes, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, etc.) within three months after the last administration of the trial drug from the date of signing the informed consent; Women of childbearing age must have a negative pregnancy test result within ≤ 7 days before the first trial drug administration. Exclusion Criteria: 1. Individuals with a known history of allergies/allergic reactions to yeast or yeast derived products, or those who are allergic to any component of the study formulation; Individuals with an allergic constitution (multiple drug or food allergies) or a history of allergies to biological products, as well as a history of severe systemic allergic reactions caused by other reasons and deemed unsuitable for treatment with the investigational drug by the researcher; 2. During the screening process, there were serious digestive system diseases and complications that the researchers deemed unsuitable for participation in this study, including but not limited to malignant ascites, diagnosis of grade III or IV hepatic encephalopathy according to the West Haven grading criteria, portal vein cancer thrombus/thrombus, circulatory dysfunction after abdominal puncture, biliary obstructive disease determined by ultrasound or other imaging examinations, gastrointestinal bleeding that stopped bleeding after treatment for less than 10 days or endoscopic ligation could not effectively stop bleeding, or those assessed by the researchers as having a high risk of bleeding during the trial period (such as severe esophagogastric varices with positive red sign on gastroscopy within 3 months before screening); 3. When screening, there is a history of active cardiovascular disease or other conditions that researchers determine are not suitable for receiving human serum albumin treatment, including but not limited to hypertension (systolic blood pressure\>140 mmHg or diastolic blood pressure\>90 mmHg, except for those determined by researchers to have good medication control and stable condition), severe anemia, acute heart disease, severe cardiovascular or structural heart disease, severe arrhythmia, decompensated heart failure (normal blood volume or high blood volume), unstable angina pectoris, myocardial infarction in the past 6 months before screening, tachycardia/bradycardia requiring medication treatment, third degree atrioventricular block, etc; 4. Active metabolic system disease or medical history (except for diabetes patients with stable blood glucose control as judged by the investigator), or combined with renal function injury, which is not suitable for serum albumin treatment as judged by the investigator; 5. When screening, there were serious underlying diseases that the researchers deemed unsuitable for participation in this study, including but not limited to active malignant tumors (including hepatocellular carcinoma \[HCC\]), pulmonary edema, bleeding tendency or active bleeding disease, uncontrolled infections (including active spontaneous bacterial peritonitis \[SBP1\]), thyroid dysfunction (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events INCICTCAEI 5.0 grade 3 or above), pleural effusion that the researchers determined may require treatment or have disease changes throughout the entire trial process, etc; 6. The patient has the following laboratory test abnormalities: (1) Bone marrow function: Absolute neutrophil count (ANC)\<1.0x10 \^ 9/L; Platelets (PLT)\<20x10 \^ 9/L; Hemoglobin (HGB)\<70gL; (2) Liver function: Alanine aminotransferase (ALT)\>5 × ULN (upper limit of normal); Aspartate aminotransferase (AST)\>5 × ULN; Serum bilirubin (TBIL)\>4 x upper limit of normal (ULN) or deemed unsuitable for participation in the trial by the researcher; (3) Renal function: serum creatinine\>3 times the upper limit of normal (ULN), positive urine protein, and the researcher's judgment that it is not suitable to participate in the trial; (4) Coagulation function: prothrombin time (PT) prolonged\>5s； 7. Individuals who have received human plasma preparations (including human albumin preparations) within 7 days prior to the first administration of the investigational drug; Individuals with a history of organ transplantation; Those who need to undergo or plan invasive invasive examinations or treatments during the research period; 8. Participated in or was participating in clinical trials of other new drugs or medical devices within 30 days prior to screening, and used the investigational drug/treatment provider; 9. Individuals who test positive for human immunodeficiency virus (HIV) antibodies; 10. Pregnant or lactating women; 11. Other reasons why researchers believe it is not suitable to participate in this study.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cirrhotic ascites

Contacts and locations

Locations

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China
Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China
Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China
Central Hospital of Hengyang

Hengyang, Hunan, 421000, China
Changsha Central Hospital

Changsha, Hunan, 410000, China
Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, 404100, China
First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, 341000, China
First People's Hospital of Chenzhou

Chenzhou, Hunan, 423000, China
Guangzhou Eighth People's Hospital, Guangzhou Medical University

Guangzhou, Guangdong, 510000, China
Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550000, China
Hebei Medical University Third Hospital

Shijiazhuang, Hebei, 050000, China
Huizhou Central People's Hospital

Huizhou, Guangdong, 516000, China
Huizhou First Hospital

Huizhou, Guangdong, 516000, China
Hunan University Of Medicine General Hospital

Huaihua, Hunan, 418000, China
Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330000, China
Jiujiang NO.1 People's Hospital

Jiujiang, Jiangxi, 332000, China
Jiujiang Third People's Hospital

Jiujiang, Jiangxi, 332000, China
Loudi Central Hospital

Loudi, Hunan, 417000, China
Luoyang Central Hospital

Luoyang, Henan, 471000, China
Luoyang Third People's Hospital

Luoyang, Henan, 471000, China
Meihekou Central Hospital

Tonghua, Jilin, 135099, China
People's Hospital of Zhengzhou

Zhengzhou, Henan, 450000, China
Pingxiang No.2 People's Hospital

Pingxiang, Jiangxi, 337000, China
Pingxiang People's Hospital

Pingxiang, Jiangxi, 337000, China
Puyang Oilfield General Hospital

Puyang, Henan, 457000, China
Shandong Public Health Clinical Center

Jinan, Shandong, 250000, China
Shenzhen People's Hospital

Shenzhen, Guangdong, 518000, China
Shenzhen Protgen Co., Ltd.

Shenzhen, Guangdong, 518000, China
Shijiangzhuang Fifth Hospital

Shijiangzhuang, Hebei, 050000, China
Shunde Hospital of Southern Medical University

Foshan, Guangdong, 528000, China
Sinopharm Dongfeng General Hospital

Shiyan, Hubei, 442000, China
Taihe Hospital

Shiyan, Hubei, 442000, China
The Central Hospital of Wuhan

Wuhan, Hubei, 430000, China
The First Affiliated Hospital of Henan University

Kaifeng, Henan, China
The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China
The First Affiliated Hospital of University of South China

Hengyang, Hunan, 421000, China
The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China
The First Hospital of Changsha

Changsha, Hunan, 410005, China
The First Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, 410000, China
The First People's Hospital of Changde City

Changde, Hunan, 415000, China
The First People's Hospital of Yunnan Province

Kunming, Yunnan, 650000, China
The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China
The Ninth Hospital of Nanchang

Nanchang, Jiangxi, 330000, China
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China
The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China
The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China
The Second People's Hospital of Yibin

Yibin, Sichuan, 644000, China
The Sixth People's Hospital of Zhengzhou

Zhengzhou, Henan, 450000, China
The Third Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China
The Third People's Hospital of Hunan Provincial

Yueyang, Hunan, 414000, China
The Third People's Hospital of Kunming city

Kunming, Yunnan, 650000, China
The central Hospital of Xiangtan

Xiangtan, Hunan, 411100, China
Wenzhou Central Hospital

Wenzhou, Zhejiang, 325000, China
Xinyang Central Hospital

Xinyang, Henan, 464000, China
Xuancheng People's Hospital

Xuancheng, Anhui, 242000, China
Yichang Central People's Hospital

Yichang, Hubei, 443000, China
Yiyang Central Hospital

Yiyang, Hunan, 413000, China
Zhejiang Chinese Medical University Affiliated Wenzhou Hospital of Traditional Chinese Medicine

Wenzhou, Zhejiang, 325000, China
Zhengzhou Central Hospital

Zhengzhou, Henan, 450000, China
Zhoukou Central Hospital

Zhoukou, Henan, 466000, China
Zhuzhou Central Hospital

Zhuzhou, Hunan, 412000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.

Could a Lab-Made protein replace donor albumin for liver patients?