Phase II/III Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites
Random, Double-blind, Parallel Group Phase II/III Clinical Trial to Evaluate the Effectiveness and Safety of Recombinant Human Serum Albumin Versus Human Serum Albumin in Hepatic Cirrhosis Patients With Ascites
1 other identifier
interventional
390
1 country
61
Brief Summary
This trial adopts random, double-blind, positive control, parallel group design to evaluate the effectiveness and safety of recombinant human serum albumin versus human serum albumin in hepatic cirrhosis patients with ascites.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2024
Shorter than P25 for phase_2
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2024
CompletedFirst Posted
Study publicly available on registry
August 14, 2024
CompletedStudy Start
First participant enrolled
August 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2025
CompletedMarch 10, 2026
March 1, 2026
9 months
August 11, 2024
March 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change of serum albumin concentration
The change in serum albumin concentration confirmed by albumin examination immediately after the completion of secondary intravenous administration compared to baseline (based on the results of central laboratory tests)
7 days
Secondary Outcomes (14)
Key Secondary Outcome Measures: The improvement rate of ascites
7 days
The change in serum albumin concentration immediately after completion of the last intravenous dose, as confirmed by albumin testing at the local laboratory
7 days
Changes in the depth of ascites
7 days
The proportion of subjects with serum albumin concentration ≥ 35 g/L
7 days
The time when serum albumin concentration reached ≥35 g/L
90 days
- +9 more secondary outcomes
Study Arms (2)
Group 1
EXPERIMENTALThe experimental drug was administered at a dose of 20 g/ day for 7 days.
Group 2
ACTIVE COMPARATORThe positive control drug was administered at a dose of 20 g/ day for 7 days.
Interventions
The experimental drug was administered at a dose of 20 g/ day for 7 days.
The positive control drug was administered at a dose of 20 g/ day for 7 days.
Eligibility Criteria
You may qualify if:
- Agree to follow the experimental treatment plan and visit schedule, voluntarily join the group, and sign a written informed consent form;
- 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);
- 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;
- 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.
You may not qualify if:
- 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;
- 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);
- 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;
- 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;
- 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;
- 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；
- 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;
- 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;
- Individuals who test positive for human immunodeficiency virus (HIV) antibodies;
- Pregnant or lactating women;
- Other reasons why researchers believe it is not suitable to participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Protgen Ltdlead
Study Sites (61)
Xuancheng People's Hospital
Xuancheng, Anhui, 242000, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000, China
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404100, China
Shunde Hospital of Southern Medical University
Foshan, Guangdong, 528000, China
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 510000, China
Huizhou Central People's Hospital
Huizhou, Guangdong, 516000, China
Huizhou First Hospital
Huizhou, Guangdong, 516000, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518000, China
Shenzhen Protgen Co., Ltd.
Shenzhen, Guangdong, 518000, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550000, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
Shijiangzhuang Fifth Hospital
Shijiangzhuang, Hebei, 050000, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 050000, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000, China
The First Affiliated Hospital of Henan University
Kaifeng, Henan, China
Luoyang Central Hospital
Luoyang, Henan, 471000, China
Luoyang Third People's Hospital
Luoyang, Henan, 471000, China
Puyang Oilfield General Hospital
Puyang, Henan, 457000, China
Xinyang Central Hospital
Xinyang, Henan, 464000, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000, China
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000, China
Zhengzhou Central Hospital
Zhengzhou, Henan, 450000, China
Zhoukou Central Hospital
Zhoukou, Henan, 466000, China
Sinopharm Dongfeng General Hospital
Shiyan, Hubei, 442000, China
Taihe Hospital
Shiyan, Hubei, 442000, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430000, China
Yichang Central People's Hospital
Yichang, Hubei, 443000, China
The First People's Hospital of Changde City
Changde, Hunan, 415000, China
Changsha Central Hospital
Changsha, Hunan, 410000, China
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 410000, China
The First Hospital of Changsha
Changsha, Hunan, 410005, China
First People's Hospital of Chenzhou
Chenzhou, Hunan, 423000, China
Central Hospital of Hengyang
Hengyang, Hunan, 421000, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421000, China
Hunan University Of Medicine General Hospital
Huaihua, Hunan, 418000, China
Loudi Central Hospital
Loudi, Hunan, 417000, China
The central Hospital of Xiangtan
Xiangtan, Hunan, 411100, China
Yiyang Central Hospital
Yiyang, Hunan, 413000, China
The Third People's Hospital of Hunan Provincial
Yueyang, Hunan, 414000, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412000, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000, China
Jiujiang NO.1 People's Hospital
Jiujiang, Jiangxi, 332000, China
Jiujiang Third People's Hospital
Jiujiang, Jiangxi, 332000, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
The Ninth Hospital of Nanchang
Nanchang, Jiangxi, 330000, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
Pingxiang No.2 People's Hospital
Pingxiang, Jiangxi, 337000, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337000, China
Meihekou Central Hospital
Tonghua, Jilin, 135099, China
Shandong Public Health Clinical Center
Jinan, Shandong, 250000, China
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650000, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000, China
The Third People's Hospital of Kunming city
Kunming, Yunnan, 650000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
The Third Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, 325000, China
Zhejiang Chinese Medical University Affiliated Wenzhou Hospital of Traditional Chinese Medicine
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jidong Jia, Ph.D
Beijing Friendship Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2024
First Posted
August 14, 2024
Study Start
August 19, 2024
Primary Completion
May 14, 2025
Study Completion
May 14, 2025
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share