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Cirrhotic AscitesPhase 2/3NCT06553456

Phase II/III Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites

A Phase 2/3 study testing Recombinant Human Serum Albumin and Human Serum Albumin in people with Cirrhotic Ascites, run by Beijing Protgen Biotechnology Development Co., Ltd. at 61 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cirrhotic Ascites
What is being tested?
Recombinant Human Serum Albumin and Human Serum Albumin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
390 participants
Where
61 sitesChina
Study dates
19 Aug 2024to 14 May 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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；
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  • 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.

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

China61 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

  • Beijing YouAn Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

  • The First People's Hospital of Changde City

    Changde, Hunan, 415000

  • Changsha Central Hospital

    Changsha, Hunan, 410000

  • The First Hospital of Hunan University of Chinese Medicine

    Changsha, Hunan, 410000

  • The First Hospital of Changsha

    Changsha, Hunan, 410005

  • First People's Hospital of Chenzhou

    Chenzhou, Hunan, 423000

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404100

  • Shunde Hospital of Southern Medical University

    Foshan, Guangdong, 528000

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341000

  • Guangzhou Eighth People's Hospital, Guangzhou Medical University

    Guangzhou, Guangdong, 510000

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, 550000

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

  • Central Hospital of Hengyang

    Hengyang, Hunan, 421000

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan, 421000

  • Hunan University Of Medicine General Hospital

    Huaihua, Hunan, 418000

  • Huizhou Central People's Hospital

    Huizhou, Guangdong, 516000

  • Huizhou First Hospital

    Huizhou, Guangdong, 516000

  • Shandong Public Health Clinical Center

    Jinan, Shandong, 250000

  • Jiujiang NO.1 People's Hospital

    Jiujiang, Jiangxi, 332000

  • Jiujiang Third People's Hospital

    Jiujiang, Jiangxi, 332000

  • The First Affiliated Hospital of Henan University

    Kaifeng, Henan

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan, 650000

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650000

  • The Third People's Hospital of Kunming city

    Kunming, Yunnan, 650000

  • Loudi Central Hospital

    Loudi, Hunan, 417000

  • Luoyang Central Hospital

    Luoyang, Henan, 471000

  • Luoyang Third People's Hospital

    Luoyang, Henan, 471000

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • The Ninth Hospital of Nanchang

    Nanchang, Jiangxi, 330000

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • Pingxiang No.2 People's Hospital

    Pingxiang, Jiangxi, 337000

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337000

  • Puyang Oilfield General Hospital

    Puyang, Henan, 457000

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518000

  • Shenzhen Protgen Co., Ltd.

    Shenzhen, Guangdong, 518000

  • Shijiangzhuang Fifth Hospital

    Shijiangzhuang, Hebei, 050000

  • Hebei Medical University Third Hospital

    Shijiazhuang, Hebei, 050000

  • Sinopharm Dongfeng General Hospital

    Shiyan, Hubei, 442000

  • Taihe Hospital

    Shiyan, Hubei, 442000

  • Meihekou Central Hospital

    Tonghua, Jilin, 135099

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • The Third Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Wenzhou Central Hospital

    Wenzhou, Zhejiang, 325000

  • Zhejiang Chinese Medical University Affiliated Wenzhou Hospital of Traditional Chinese Medicine

    Wenzhou, Zhejiang, 325000

  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430000

  • The central Hospital of Xiangtan

    Xiangtan, Hunan, 411100

  • Xinyang Central Hospital

    Xinyang, Henan, 464000

  • Xuancheng People's Hospital

    Xuancheng, Anhui, 242000

  • The Second People's Hospital of Yibin

    Yibin, Sichuan, 644000

  • Yichang Central People's Hospital

    Yichang, Hubei, 443000

  • Yiyang Central Hospital

    Yiyang, Hunan, 413000

  • The Third People's Hospital of Hunan Provincial

    Yueyang, Hunan, 414000

  • People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450000

  • The Sixth People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450000

  • Zhengzhou Central Hospital

    Zhengzhou, Henan, 450000

  • Zhoukou Central Hospital

    Zhoukou, Henan, 466000

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan, 412000

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563000

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

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.

In this trial（phase III）, the efficacy of rHSA will be evaluated by the change in serum albumin concentration immediately after the last intravenous administration from baseline, and its safety, PD characteristics and immunogenicity will be further evaluated.

Being tested
Recombinant Human Serum Albumin, Human Serum Albumin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant Human Serum AlbuminDrug

    The experimental drug was administered at a dose of 20 g/ day for 7 days.

  • Human Serum AlbuminDrug

    The positive control drug was administered at a dose of 20 g/ day for 7 days.

Study groups in NCT06553456
Study groupRoleWhat they receive
Group 1ExperimentalThe experimental drug was administered at a dose of 20 g/ day for 7 days.
Receives: Drug: Recombinant Human Serum Albumin
Group 2Active comparatorThe positive control drug was administered at a dose of 20 g/ day for 7 days.
Receives: Drug: Human Serum Albumin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 7 days

Secondary outcomes (14)

  1. Key Secondary Outcome Measures: The improvement rate of ascites

    The improvement rate of ascites at the completion of the last intravenous administration

    Measured: 7 days

  2. The change in serum albumin concentration immediately after completion of the last intravenous dose, as confirmed by albumin testing at the local laboratory

    The change in serum albumin concentration confirmed by local laboratory albumin test immediately after the last intravenous administration compared to baseline

    Measured: 7 days

  3. Changes in the depth of ascites

    Changes in ascites depth from baseline upon completion of the last intravenous administration

    Measured: 7 days

  4. The proportion of subjects with serum albumin concentration ≥ 35 g/L

    The proportion of subjects whose serum albumin concentration confirmed by albumin examination at the completion of the last intravenous administration is ≥ 35 g/L

    Measured: 7 days

  5. The time when serum albumin concentration reached ≥35 g/L

    The time when serum albumin concentration reached ≥35 g/L

    Measured: 90 days

  6. Changes in abdominal circumference

    Changes in abdominal circumference compared to baseline at the completion of the last intravenous administration

    Measured: 7 days

  7. Changes in body weight

    Changes in body weight compared to baseline at the completion of the last intravenous administration

    Measured: 7 days

  8. The change in serum albumin concentration during the re-treatment period

    The change in serum albumin concentration confirmed by albumin examination immediately after the completion of the last intravenous administration during the re-treatment period compared to the baseline before the re-treatment

    Measured: 7 days

  9. The improvement rate of ascites during the re-treatment period

    The improvement rate of ascites at the completion of the last intravenous administration during the re-treatment period

    Measured: 7 days

  10. Changes in the depth of ascites during the re-treatment period

    Changes in ascites depth at the completion of the last intravenous administration during the re-treatment period compared to baseline before the re-treatment

    Measured: 7 days

  11. The proportion of subjects with serum albumin concentration ≥ 35 g/L during the re-treatment period

    Proportion of subjects with serum albumin concentration ≥ 35 g/L confirmed by albumin examination during the re-treatment period

    Measured: 7 days

  12. The time when serum albumin concentration reached ≥35 g/L during the re-treatment period

    The time when the serum albumin concentration confirmed by the albumin test during the re-treatment period reaches ≥ 35 g/L

    Measured: 7 days

  13. Changes in abdominal circumference during the re-treatment period

    Changes in abdominal circumference at the completion of the last intravenous administration during the re-treatment period compared to baseline before the re-treatment

    Measured: 7 days

  14. Changes in body weight during the re-treatment period

    Changes in body weight at the completion of the last intravenous administration during the re-treatment period compared to baseline before the re-treatment

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2024
  2. Study start19 Aug 2024
  3. Primary completion14 May 2025
  4. Study completion14 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
390 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06553456
Sponsor's protocol ID
rHSA 2020-3 (Phase Ⅲ)
Status last verified
Mar 2026
First submitted
11 Aug 2024
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Recombinant Human Serum Albumin and Human Serum Albumin in people with Cirrhotic Ascites, run by Beijing Protgen Biotechnology Development Co., Ltd. at 61 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of serum albumin concentration (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06553456.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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