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AscitesPhase 1NCT04701697

Phase Ib of Recombinant Human Albumin Injection

A Phase 1 study testing Recombinant Human Albumin Injection and HumanAlbumin in people with 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

A Randomized, Multicenter,Open-label, positive-controlled, Multi-dose Phase 1 Study to Evaluate the Safety, Tolerance,Efficacy, Pharmacokinetics and Immunogenicity of recombinant human albumin injection in Patients With Hepatic Cirrhosis Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ascites
What is being tested?
Recombinant Human Albumin Injection and HumanAlbumin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
15 Mar 2020to 25 Oct 2020
Phase
Phase 1
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

  • 18-75 years of age;
  • No less than 45 kg.
  • Diagnosed with ascites due to cirrhosis.

Who cannot join

  • Allergy to biological products;
  • West-Haven HE ≥ III ;
  • Uncontrolled severe infections;
  • HRS. Serum creatinine (Cr)>2×ULN, or Cr increase>50% during the screening period;
  • Combined with other serious underlying diseases.
  • Organ transplant recipients;
Show all 13Show fewer
  • Child-bearing females. Pregnancy test positive. Refusing to take contraceptive measures; (8) Participation in other clinical trials. Using study drugs within three month; (9) With the following laboratory test abnormality:
  • PLT<30×109/L, HGB<70 g/L;
  • ALT and (or) AST> 5×ULN, TBIL>3×ULN;
  • Prothrombin activity <40%, PT prolonged>5s;
  • LVEF <50%;
  • The 24h urine volume exceeds 1500 mL/day ;
  • 10) Other subjects by investigator's opinion.

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: Phase Ib Study of Recombinant Human Albumin Injection for the Treatment of Ascites in Patients With Hepatic Cirrhosis

A Randomized, Multicenter,Open-label, positive-controlled, Multi-dose Phase 1 Study to Evaluate the Safety, Tolerance,Efficacy, Pharmacokinetics and Immunogenicity of recombinant human albumin injection in Patients With Hepatic Cirrhosis

Read the detailed description

This study was to evaluate the safety, tolerability,efficacy, pharmacokinetics and immunogenicity of recombinant human albumin injection in Patients With Hepatic Cirrhosis. The study design consists of two phases: Screening and treatment phase(dose increasing stage).Following the Screening phase, all eligible subjects will be randomized to receive recombinant human albumin injection or HumanAlbumin, study medication in a 3:1 ratio.Dose increasing stage (including 3 dose groups with increasing dose, and each group was set with HumanAlbumin control).The initial dose was 10g. The highest dose group was set at 30g.

Conditions
Ascites
Being tested
Recombinant Human Albumin Injection, HumanAlbumin
Medical subject headings
Ascites

What participants receive

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

  • Recombinant Human Albumin InjectionDrug

    Also called Intravenous infusion of human albumin injection

    Participants will receive Recombinant Human Albumin Injection of intravenous infusion

  • HumanAlbuminDrug

    Also called Intravenous infusion of recombinant human albumin injection

    Participants will receive HumanAlbumin of intravenous infusion

Study groups in NCT04701697
Study groupRoleWhat they receive
active comparator：HumanAlbuminActive comparatorParticipants received HumanAlbumin 10g/d
Receives: Drug: HumanAlbumin
Experimental:Recombinant Human Albumin Injection 10gExperimentalParticipants received Recombinant Human Albumin Injection 10g/d
Receives: Drug: Recombinant Human Albumin Injection
Experimental:Recombinant Human Albumin Injection 20gExperimentalParticipants received Recombinant Human Albumin Injection 20g/d
Receives: Drug: Recombinant Human Albumin Injection
Experimental:Recombinant Human Albumin Injection 30gExperimentalParticipants received Recombinant Human Albumin Injection 30g/d
Receives: Drug: Recombinant Human Albumin Injection

What is being measured

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

  1. Safety and tolerance

    Incidence and severity of adverse events

    Measured: Day 1-Day 14（approximately，After the treatment）

Secondary outcomes (13)

  1. Major efficacy character: Albumin concentration change

    Albumin concentration change from baseline to Day 14（approximately，After the treatment）

    Measured: Day 1-Day 14（approximately，After the treatment）

  2. Efficacy：Ascites regression rate

    Ascites regression rate from baseline at Day 14（approximately，After the treatment）

    Measured: Day 1-Day 14（approximately，After the treatment）

  3. Efficacy：Ascites resolution time

    Ascites resolution time

    Measured: Day 1-Day 14（approximately，After the treatment）

  4. Efficacy： HRS (hepato-renal syndrom)

    Incidence of HRS

    Measured: Day 1-Day 14（approximately，After the treatment）

  5. Efficacy： OHE(overt hepatic encephalopathy)

    Incidence of OHE

    Measured: Day 1-Day 14（approximately，After the treatment）

  6. Efficacy： abdominal circumference

    Change of abdominal circumference from baseline at Day 14（approximately，After the treatment）

    Measured: Day 1-Day 14（approximately，After the treatment）

  7. Efficacy：Weight

    Change of Weight from baseline at Day 14（approximately，After the treatment）

    Measured: Day 1-Day 14（approximately，After the treatment）

  8. Pharmacodynamic parameters

    Plasma colloidal osmotic pressure change from baseline

    Measured: Day 1-Day 29

  9. PK parameters

    Maximum Plasma Concentration（Cmax）of ALB as Recombinant Human Albumin administration occur

    Measured: Day 1-Day 29

  10. PK parameters

    Time to Maximum Plasma Concentration（Tmax）of ALB as Recombinant Human Albumin administration occur

    Measured: Day 1-Day 29

  11. PK parameters

    Half life (t1/2）as Recombinant Human Albumin administration occur

    Measured: Day 1-Day 29

  12. PK parameters

    Area under the curve(AUC) as Recombinant Human Albumin administration occur

    Measured: Day 1-Day 29

  13. Immunogenicity

    Percentage of patients with positive reaction against human albumin

    Measured: Day 1-Day 29

Timeline

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

  1. First posted8 Jan 2021
  2. Study start15 Mar 2020
  3. Primary completion10 Sep 2020
  4. Study completion25 Oct 2020

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04701697
Sponsor's protocol ID
ART-2019-002
Status last verified
Nov 2020
First submitted
29 Nov 2020
Last updated
8 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang X, Li W, Kong F, Guo X, Jin Q, Gao R, Hu Y, Cai Y, Xin G, Ji H, Piao H, Fu Z, Wang Y, Piao Z, Wang S, Hua R, Wen X, Qi Y, Jin J, Wang C, Wang Z, Xu F, Zhou Q, Li X, Yu G, Wang Y, Yang T, Xiang W, Pan Y, Niu J, Gao Y. A randomized, phase Ib trial of recombinant human serum albumin in cirrhotic patients with ascites. Hepatol Int. 2026 Feb;20(1):91-101. doi: 10.1007/s12072-025-10871-x. Epub 2025 Jul 23.

    PubMed 40699522

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Recombinant Human Albumin Injection and HumanAlbumin in people with 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 3 inclusion and 13 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 8 Jan 2021. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Safety and tolerance (time frame: Day 1-Day 14（approximately，After the treatment）). 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 NCT04701697, which also lists 1 linked publication.

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 8 Jan 2021.

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