Back to resultsPhase Ib of Recombinant Human Albumin Injection
Primary Purpose
Ascites
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Recombinant Human Albumin Injection
HumanAlbumin
Sponsored by
About this trial
This is an interventional treatment trial for Ascites
Eligibility Criteria
Inclusion Criteria:
- 18-75 years of age;
- No less than 45 kg.
- Diagnosed with ascites due to cirrhosis.
Exclusion Criteria:
- 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 ;
10) Other subjects by investigator's opinion.
Sites / Locations
- the first hospital of Jilin University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
active comparator：HumanAlbumin
Experimental:Recombinant Human Albumin Injection 10g
Experimental:Recombinant Human Albumin Injection 20g
Experimental:Recombinant Human Albumin Injection 30g
Arm Description
Participants received HumanAlbumin 10g/d
Participants received Recombinant Human Albumin Injection 10g/d
Participants received Recombinant Human Albumin Injection 20g/d
Participants received Recombinant Human Albumin Injection 30g/d
Outcomes
Primary Outcome Measures
Safety and tolerance
Incidence and severity of adverse events
Secondary Outcome Measures
Major efficacy character: Albumin concentration change
Albumin concentration change from baseline to Day 14（approximately，After the treatment）
Efficacy：Ascites regression rate
Ascites regression rate from baseline at Day 14（approximately，After the treatment）
Efficacy：Ascites resolution time
Ascites resolution time
Efficacy： HRS (hepato-renal syndrom)
Incidence of HRS
Efficacy： OHE(overt hepatic encephalopathy)
Incidence of OHE
Efficacy： abdominal circumference
Change of abdominal circumference from baseline at Day 14（approximately，After the treatment）
Efficacy：Weight
Change of Weight from baseline at Day 14（approximately，After the treatment）
Pharmacodynamic parameters
Plasma colloidal osmotic pressure change from baseline
PK parameters
Maximum Plasma Concentration（Cmax）of ALB as Recombinant Human Albumin administration occur
PK parameters
Time to Maximum Plasma Concentration（Tmax）of ALB as Recombinant Human Albumin administration occur
PK parameters
Half life (t1/2）as Recombinant Human Albumin administration occur
PK parameters
Area under the curve(AUC) as Recombinant Human Albumin administration occur
Immunogenicity
Percentage of patients with positive reaction against human albumin
Full Information
NCT ID
NCT04701697
First Posted
November 29, 2020
Last Updated
January 6, 2021
Sponsor
The First Hospital of Jilin University
1. Study Identification
Unique Protocol Identification Number
NCT04701697
Brief Title
Phase Ib of Recombinant Human Albumin Injection
Official Title
Phase Ib Study of Recombinant Human Albumin Injection for the Treatment of Ascites in Patients With Hepatic Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2020 (Actual)
Primary Completion Date
September 10, 2020 (Actual)
Study Completion Date
October 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Hospital of Jilin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascites
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active comparator：HumanAlbumin
Arm Type
Active Comparator
Arm Description
Participants received HumanAlbumin 10g/d
Arm Title
Experimental:Recombinant Human Albumin Injection 10g
Arm Type
Experimental
Arm Description
Participants received Recombinant Human Albumin Injection 10g/d
Arm Title
Experimental:Recombinant Human Albumin Injection 20g
Arm Type
Experimental
Arm Description
Participants received Recombinant Human Albumin Injection 20g/d
Arm Title
Experimental:Recombinant Human Albumin Injection 30g
Arm Type
Experimental
Arm Description
Participants received Recombinant Human Albumin Injection 30g/d
Intervention Type
Drug
Intervention Name(s)
Recombinant Human Albumin Injection
Other Intervention Name(s)
Intravenous infusion of human albumin injection
Intervention Description
Participants will receive Recombinant Human Albumin Injection of intravenous infusion
Intervention Type
Drug
Intervention Name(s)
HumanAlbumin
Other Intervention Name(s)
Intravenous infusion of recombinant human albumin injection
Intervention Description
Participants will receive HumanAlbumin of intravenous infusion
Primary Outcome Measure Information:
Title
Safety and tolerance
Description
Incidence and severity of adverse events
Time Frame
Day 1-Day 14（approximately，After the treatment）
Secondary Outcome Measure Information:
Title
Major efficacy character: Albumin concentration change
Description
Albumin concentration change from baseline to Day 14（approximately，After the treatment）
Time Frame
Day 1-Day 14（approximately，After the treatment）
Title
Efficacy：Ascites regression rate
Description
Ascites regression rate from baseline at Day 14（approximately，After the treatment）
Time Frame
Day 1-Day 14（approximately，After the treatment）
Title
Efficacy：Ascites resolution time
Description
Ascites resolution time
Time Frame
Day 1-Day 14（approximately，After the treatment）
Title
Efficacy： HRS (hepato-renal syndrom)
Description
Incidence of HRS
Time Frame
Day 1-Day 14（approximately，After the treatment）
Title
Efficacy： OHE(overt hepatic encephalopathy)
Description
Incidence of OHE
Time Frame
Day 1-Day 14（approximately，After the treatment）
Title
Efficacy： abdominal circumference
Description
Change of abdominal circumference from baseline at Day 14（approximately，After the treatment）
Time Frame
Day 1-Day 14（approximately，After the treatment）
Title
Efficacy：Weight
Description
Change of Weight from baseline at Day 14（approximately，After the treatment）
Time Frame
Day 1-Day 14（approximately，After the treatment）
Title
Pharmacodynamic parameters
Description
Plasma colloidal osmotic pressure change from baseline
Time Frame
Day 1-Day 29
Title
PK parameters
Description
Maximum Plasma Concentration（Cmax）of ALB as Recombinant Human Albumin administration occur
Time Frame
Day 1-Day 29
Title
PK parameters
Description
Time to Maximum Plasma Concentration（Tmax）of ALB as Recombinant Human Albumin administration occur
Time Frame
Day 1-Day 29
Title
PK parameters
Description
Half life (t1/2）as Recombinant Human Albumin administration occur
Time Frame
Day 1-Day 29
Title
PK parameters
Description
Area under the curve(AUC) as Recombinant Human Albumin administration occur
Time Frame
Day 1-Day 29
Title
Immunogenicity
Description
Percentage of patients with positive reaction against human albumin
Time Frame
Day 1-Day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-75 years of age;
No less than 45 kg.
Diagnosed with ascites due to cirrhosis.
Exclusion Criteria:
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 ;
10) Other subjects by investigator's opinion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junqi Niu, Dr
Organizational Affiliation
The first affiliated hospital of Jilin University
Official's Role
Study Director
Facility Information:
Facility Name
the first hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
12. IPD Sharing Statement
Learn more about this trial
Phase Ib of Recombinant Human Albumin Injection
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