NCT04701697

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 29, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
Last Updated

January 8, 2021

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

November 29, 2020

Last Update Submit

January 6, 2021

Conditions

Ascites

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerance

    Incidence and severity of adverse events

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

Secondary Outcomes (13)

  • Major efficacy character: Albumin concentration change

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

  • Efficacy：Ascites regression rate

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

  • Efficacy：Ascites resolution time

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

  • Efficacy： HRS (hepato-renal syndrom)

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

  • Efficacy： OHE(overt hepatic encephalopathy)

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

  • +8 more secondary outcomes

Study Arms (4)

active comparator：HumanAlbumin

ACTIVE COMPARATOR

Participants received HumanAlbumin 10g/d

Drug: HumanAlbumin

Experimental:Recombinant Human Albumin Injection 10g

EXPERIMENTAL

Participants received Recombinant Human Albumin Injection 10g/d

Drug: Recombinant Human Albumin Injection

Experimental:Recombinant Human Albumin Injection 20g

EXPERIMENTAL

Participants received Recombinant Human Albumin Injection 20g/d

Drug: Recombinant Human Albumin Injection

Experimental:Recombinant Human Albumin Injection 30g

EXPERIMENTAL

Participants received Recombinant Human Albumin Injection 30g/d

Drug: Recombinant Human Albumin Injection

Interventions

Recombinant Human Albumin InjectionDRUG

Participants will receive Recombinant Human Albumin Injection of intravenous infusion

Also known as: Intravenous infusion of human albumin injection
Experimental:Recombinant Human Albumin Injection 10gExperimental:Recombinant Human Albumin Injection 20gExperimental:Recombinant Human Albumin Injection 30g
HumanAlbuminDRUG

Participants will receive HumanAlbumin of intravenous infusion

Also known as: Intravenous infusion of recombinant human albumin injection
active comparator：HumanAlbumin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;
  • 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 ;
  • \) Other subjects by investigator's opinion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the first hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Related Publications (1)

  • 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. 2025 Jul 23. doi: 10.1007/s12072-025-10871-x. Online ahead of print.

    PMID: 40699522DERIVED

MeSH Terms

Conditions

Ascites

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Junqi Niu, Dr

    The first affiliated hospital of Jilin University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2020

First Posted

January 8, 2021

Study Start

March 15, 2020

Primary Completion

September 10, 2020

Study Completion

October 25, 2020

Last Updated

January 8, 2021

Record last verified: 2020-11

Locations

CN(1)