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Hepatic AscitesPhase 3NCT06911554

A Study of Recombinant Human Albumin Injection to Treat Hypoalbuminemia in Cirrhotic Patients With Ascites

A Phase 3 study testing Recombinant Human Albumin Injection and Human Albumin in people with Hepatic Ascites, run by Tonghua Anrate Biopharmaceutical Co., Ltd. at 1 site in China.

Completed

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

Official record
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Trial summary

This study was a Phase III multicenter, blinded, and positive active-controlled clinical study to evaluate the efficacy, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatic Ascites
What is being tested?
Recombinant Human Albumin Injection and Human Albumin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
416 participants
Where
1 siteChina
Study dates
16 Jun 2023to 27 Sep 2024
Phase
Phase 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects aged 18-75 years (inclusive）.
  • BMI≥18.0 kg/m^2.
  • Subjects who were diagnosed as liver cirrhosis with ascites according to the Guidelines for Diagnosis and Treatment of Liver Cirrhosis with Ascites and Related Complications (2017) issued by the Chinese Society of Hepatology CMA, with ascites graded 1-2 at diagnosis or after treatment, and also met the requirement of ALB < 30 g/L ;
  • Subjects who were able to understand and comply with the study procedures, voluntarily participated this study, and had signed the informed consent form (ICF).

Who cannot join

  • Subjects with a history of allergies to biological products derived from Escherichia coli, yeast, or Chinese hamster ovary (CHO) cells, or blood products such as HSA.
  • Subjects with hepatic encephalopathy of West-Haven HE Grade III or higher.
  • Subjects with uncontrolled infections, such as body temperature > 37.5°C, white blood cell count > 1.0 × 10^10/L, or severe abdominal infection, upper respiratory tract infection, lower respiratory tract infection, urinary system infection, etc.).
  • Subjects with a history of hepatorenal syndrome (HRS), or serum creatinine (Cr) > 2 × the upper limit of normal (ULN), or Cr increased by > 50% during screening period; or presence of urine protein 2+ or more.
  • Subjects with other severe underlying conditions that, in the opinion of the investigator, affected the participation in this study, including but not limited to malignancies (exclusion criteria below for liver cancer patients), complicated portal vein thrombosis, non-cirrhotic portal hypertension-related ascites, ischemic heart disease, stroke, chronic obstructive pulmonary disease, and Grade III-IV (NYHA) heart failure, and those with gastrointestinal bleeding who had stopped bleeding for less than 14 days after treatment or failed to stop bleeding after endoscopic variceal ligation.
  • Subjects with stage C and D liver cancer (according to the Barcelona liver cancer staging criteria), or hepatocellular carcinoma (HCC) stage A/B requiring chemotherapy, intervention, surgery, or a combination of liver cancer Patients with hepatic venous cancer thrombus;
Show all 12Show fewer
  • transplant subjects
  • Female subjects of childbearing age who test positive for serological pregnancy, or female subjects of childbearing age and male subjects who refuse to use contraception during the trial period or within 6 months after the last dose;
  • Subjects who had participated in other clinical trials and used the investigational drug within 3 months prior to screening.
  • The patient has the following laboratory test abnormalities: (1) Platelets (PLT)<30x10 ^ 9/L; Hemoglobin (HGB)<70gL; (2) Alanine aminotransferase (ALT)>5 × ULN (upper limit of normal); Aspartate aminotransferase (AST)>5 × ULN; Serum bilirubin (TBIL)>3 x upper limit of normal (ULN) ; (3) Prothrombin activity was <40%, and prothrombin time (PT) was longer than 5s; (4) Left ventricular ejection fraction (LVEF) <50%.
  • Individuals who test positive for human immunodeficiency virus (HIV) antibodies; Treponema pallidum specific antibody positive and treponema pallidum non-specific antibody titer positive (unless no intervention is required during the study period assessed by the investigator);
  • Other reasons the investigator considered not suitable to participate in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

Other trials in China

About this study

Official title: A Phase III Clinical Study of Recombinant Human Albumin Injection for the Treatment of Hypoalbuminemia in Cirrhotic Patients With Ascites

This study was a Phase III multicenter, blinded, and positive active-controlled clinical study to evaluate the efficacy, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites.

Read the detailed description

This study was a Phase III multicenter, blinded, and positive active-controlled clinical study to evaluate the efficacy, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites.After the primary efficacy endpoint ALB reaches the equivalence standard (-2 g/L to 2 g/L, test drug - control drug), a non-inferiority judgment will be made for the key secondary efficacy endpoint of the improvement rate of ascites depth (> -10%, test drug - control drug). Dosage: 20 g/day once daily for 7 days.

Conditions
Hepatic Ascites
Being tested
Recombinant Human Albumin Injection, Human Albumin
Keywords
Hepatic Ascites

What participants receive

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

  • Recombinant Human Albumin InjectionBiological

    Recombinant Human Albumin injection, strength: 10 g/vial (20%, 50 mL); storage conditions: 2-8°C, protected from light; manufactured and supplied by Tonghua Anrate Biopharmaceutical Co., Ltd.

  • Human AlbuminBiological

    Human Albumin (An Pu Lai Shi®), strength: 10 g/vial (protein concentration 20%, 50 mL/vial), storage conditions: 2-8°C, protected from light; manufactured by Shanghai RAAS Blood Products Co., Ltd.

Study groups in NCT06911554
Study groupRoleWhat they receive
Treatment groupExperimentalRecombinant Human Albumin Injection, 20g/day, once daily for 7 days
Receives: Biological: Recombinant Human Albumin Injection
Control groupActive comparatorHuman Albumin, 20g/day, once daily for 7 days
Receives: Biological: Human Albumin

What is being measured

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

  1. Change from baseline in ALB

    The change in albumin (ALB) was determined by calculating the difference between the value measured after the last dose (immediately after the end of dosing) and the value measured before the first dose (the mean).

    Measured: Day -1/7

Secondary outcomes (2)

  1. Improvement rate of ascites depth

    Improvement of ascites depth is defined as:

    • Ascites subside in patients with baseline grade 1 ascites (none Ascites);
    • Ascites degrade in patients with baseline grade 2 ascites (ascites grade 1 or no ascites) and ascites depth drop more than 1cm;
    • Ascites depth of patients with baseline ascites grade 2 decrease by ≥ 25% and the ascites depth drop more than 1cm.

    Measured: Day -1/7

  2. Clinical comprehensive improvement rate

    The comprehensive clinical improvement was mainly based on changes in body weight and abdominal circumference. The classification and definition are:

    • Significant improvement: weight loss ≥ 1 kg, abdominal circumference improvement ≥ 2 cm;
    • Improvement: weight loss ≥ 1 kg, abdominal circumference reduction less than 2 cm; or weight loss less than 1 kg, abdominal circumference reduction ≥2 cm;
    • General improvement: abdominal circumference reduction less than 2cm and weight loss less than 1 kg;
    • Unchanged: no change or abdominal circumference reduction less than 2 cm, no change in body weight or slight increase (increase less than 1 kg); or no change in weight or loss less than 1 kg, no change in abdominal circumference or slight increase (increase less than 2cm);
    • Deterioration: Weight increase ≥ 1 kg or abdominal circumference increase ≥ 2 cm;
    • Can not judge as classified above. Improvement rate is defined as the proportion of significant improvement and Improvement subject.

    Measured: Day -1/7

Timeline

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

  1. First posted4 Apr 2025
  2. Study start16 Jun 2023
  3. Primary completion27 Sep 2024
  4. Study completion27 Sep 2024

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06911554
Sponsor's protocol ID
ART-2021-005
Status last verified
Apr 2025
First submitted
25 Mar 2025
Last updated
4 Apr 2025
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 3 study testing Recombinant Human Albumin Injection and Human Albumin in people with Hepatic Ascites, run by Tonghua Anrate Biopharmaceutical Co., Ltd. at 1 site 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 12 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 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 phase mean?

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 from baseline in ALB (time frame: Day -1/7). 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 NCT06911554.

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 4 Apr 2025.

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