Hepatic AscitesPhase 2NCT06411743

Phase II/III of Recombinant Human Albumin Injection

A Phase 2 study testing Recombinant Human Albumin Injection and Human Albumin in people with Hepatic Ascites, run by The First Hospital of Jilin University 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 II/III multicenter, blinded, and positiveactive-controlled clinical study with seamless adaptive design to evaluate the dose-response relationship, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites, and… Read more about this study

Who is it for?: Ages 18 to 65 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: 90 participants
Where: 1 siteChina
Study dates: 7 Sep 2021to 15 Aug 2022
Phase: Phase 2
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects aged 18-65 years (inclusive).
Subjects with body weight ≥ 55.0 kg.
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 (based on test values on Day -14 to Day -3).
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 > 9.5 × 10^9/L, or neutrophil percentage > 80% (including 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% duringat 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 (except for liver cancer patients without portal vein or hepatic vein tumor thrombosis), complicated portal vein thrombosis, non-cirrhotic portal hypertension-related ascites, ischemic heart disease, stroke, chronic obstructive pulmonary disease, and Grade III-IV 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 organ transplant.

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Female subjects of childbearing potential who had a positive serum pregnancy test, or subjects refused to use contraceptive measures during the study.
Subjects who had participated in other clinical trials and received investigational drugs within 3 months prior to screening.
Subjects with abnormal laboratory test values:a.Hematology: platelets (PLT) < 30 × 10^9/L, hemoglobin (HGB) < 70 g/L;b.Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5 × ULN, serum total bilirubin (TBIL) > 3 × ULN;c.Prothrombin activity < 40%, prothrombin time (PT) prolonged by > 5 seconds;d.Left ventricular ejection fraction (LVEF) < 50%.
Subjects who were considered inappropriate for participation in the study by the investigator due to other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Hospital of Jilin University (Leading Site)
Changchun, Jilin, 130021

Other trials in China

About this study

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

Read the detailed description

This study was a Phase II/III multicenter, blinded, and positive-controlled clinical study with seamless adaptive design. The Phase II clinical study was conducted first, followed by the Phase III clinical study.The Phase II clinical study aimed to evaluate the dose-response relationship, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites, and provide a reference for the design of Phase III clinical study. Dosage: For the 10 g/day rHA injection group, the subjects were administered rHA at a dose of 10 g/day once daily for 14 days. For the 20 g/day rHA injection group, the subjects were administered rHA at a dose of 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 NCT06411743
Study group	Role	What they receive
Treatment group1	Experimental	Recombinant Human Albumin Injection,10g/day, once daily for 14 days Receives: Biological: Recombinant Human Albumin Injection
Treatment group2	Experimental	Recombinant Human Albumin Injection,20g/day ,once daily for 7 days Receives: Biological: Recombinant Human Albumin Injection
Control group1	Active comparator	Human Albumin,10g/day, once daily for 14 days Receives: Biological: Human Albumin
Control group2	Active comparator	Human 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.

Change from baseline in ALB
The change in 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 (5)

Proportion of subjects with serum ALB level reaching 35 g/L at the end of administration
It referred to the proportion of subjects with serum ALB level ≥ 35 g/L at the end of dosing to the total number of subjects in that dose group.
Measured: Day 7/14
Time taken to attain serum ALB of 35 g/L
Defined as the time required from the first administration to serum ALB level ≥ 35 g/L.
Measured: Day1- Day7/14
Change from baseline in body weight of subjects at the end of administration
Change of body weight referred to the change in body weight after the end of dosing compared with the body weight on Day -1, which served as the baseline value. Please note that the body weight should be measured without urination under fasting conditions.
Measured: Day 7/14
Change from baseline in abdominal circumference of subjects at the end of administration
It referred to the change in abdominal circumference at the end of treatment compared with the abdominal circumference on the last day of the pre-dose observation period, which served as a reference. Please note that the abdominal circumference should be measured without urination under fasting conditions.
Measured: Day 7/14
Change from baseline in ascites depth of participantsubjects at the end of administration
It referred to the change in ascites depth at the end of dosing compared with the ascites depth on Day -1, which served as the baseline value.
Measured: Day 7/14

Timeline

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

7 Sep 202115 Aug 2022

First posted13 May 2024
Study start7 Sep 2021
Primary completion15 Aug 2022
Study completion15 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatic AscitesStudies of the same condition, open and under way.
More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06411743
Sponsor's protocol ID: ART-2021-005
Status last verified: Mar 2024
First submitted: 29 Mar 2024
Last updated: 13 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The privacy of the participants will be kept strictly confidential to the investigator, the staff participating in the study, the sponsor, and the corresponding treatment. The study protocol, records, data, and all other information generated will be kept strictly confidential.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
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VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
Ascites, Variceal Bleeding
Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
End-stage Liver Disease (ESLD), Cirrhosis, Liver
RecruitingPhase 2
Empagliflozin in Patients With Cirrhosis and Ascites
Cirrhosis, Liver Failure
Not yet recruitingObservational study
Using Bedside Ultrasound to Understand Fluid Management in Patients With Chronic Liver Disease
Cirrhosis, Ascites Hepatic

All Hepatic Ascites trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II/III Clinical Study of Recombinant Human Albumin Injection for the Treatment of Hypoalbuminemia in Cirrhotic Patients With Ascites
ClinicalTrials.gov ID: NCT06411743
Acronym / sponsor ID: ART-2021-005
Conditions: Hepatic Ascites
Keywords: Hepatic Ascites
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: The First Hospital of Jilin UniversityUniversity, hospital or other
Study start: 7 Sep 2021 (actual)
Primary completion: 15 Aug 2022 (actual)
Study completion: 15 Aug 2022 (actual)
First posted: 13 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Treatment group1	Experimental	Biological: Recombinant Human Albumin InjectionRecombinant Human Albumin Injection,10g/day, once daily for 14 days
Treatment group2	Experimental	Biological: Recombinant Human Albumin InjectionRecombinant Human Albumin Injection,20g/day ,once daily for 7 days
Control group1	Active comparator	Biological: Human AlbuminHuman Albumin,10g/day, once daily for 14 days
Control group2	Active comparator	Biological: Human AlbuminHuman Albumin,20g/day, once daily for 7 days

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female subjects aged 18-65 years (inclusive).
Subjects with body weight ≥ 55.0 kg.
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 (based on test values on Day -14 to Day -3).
Subjects who were able to understand and comply with the study procedures, voluntarily participated this study, and had signed the informed consent form (ICF).

Key exclusion criteria (10 listed)

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 > 9.5 × 10^9/L, or neutrophil percentage > 80% (including 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% duringat 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 (except for liver cancer patients without portal vein or hepatic vein tumor thrombosis), complicated portal vein thrombosis, non-cirrhotic portal hypertension-related ascites, ischemic heart disease, stroke, chronic obstructive pulmonary disease, and Grade III-IV 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Recombinant Human Albumin InjectionRecombinant 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.	Biological	Treatment group1, Treatment group2
Human AlbuminHuman 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.	Biological	Control group1, Control group2

Primary outcome

Change from baseline in ALB
Time frame: Day -1/7
The change in 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).

5 secondary outcomes

Proportion of subjects with serum ALB level reaching 35 g/L at the end of administration
Time frame: Day 7/14
Time taken to attain serum ALB of 35 g/L
Time frame: Day1- Day7/14
Change from baseline in body weight of subjects at the end of administration
Time frame: Day 7/14
Change from baseline in abdominal circumference of subjects at the end of administration
Time frame: Day 7/14
Change from baseline in ascites depth of participantsubjects at the end of administration
Time frame: Day 7/14

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
Individual participant dataSharing planned: No. The privacy of the participants will be kept strictly confidential to the investigator, the staff participating in the study, the sponsor, and the corresponding treatment. The study protocol, records, data, and all other information generated will be kept strictly confidential.

Related trials for Hepatic Ascites

Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
Portal Hypertension Related to Cirrhosis, Ascites
RecruitingObservational study
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
Ascites, Variceal Bleeding
Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
End-stage Liver Disease (ESLD), Cirrhosis, Liver
RecruitingPhase 2
Empagliflozin in Patients With Cirrhosis and Ascites
Cirrhosis, Liver Failure
Not yet recruitingObservational study
Using Bedside Ultrasound to Understand Fluid Management in Patients With Chronic Liver Disease
Cirrhosis, Ascites Hepatic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Junqi Junqi principal investigator

The First Hospital of Jilin University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant Human Albumin Injection and Human Albumin in people with Hepatic Ascites, run by The First Hospital of Jilin University 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 10 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 13 May 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 NCT06411743.

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 13 May 2024.