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Phase II/III of Recombinant Human Serum Albumin

Primary Purpose

Hepatic Ascites

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Recombinant Human Serum Albumin
Recombinant Human Serum Albumin
Human serum albumin
Human serum albumin
Sponsored by
Protgen Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Ascites

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Agreed to follow the experimental treatment plan and visit plan, voluntarily enrolled in the group, and signed the informed consent in person; Age ≥18 years old and ≤70 years old, regardless of gender, on the date of signing the informed consent; Body mass index (BMI) was in the range of 18.0 to 29.0 kg/m2 (including boundary values); Patients clinically diagnosed with decompensated cirrhosis with ascites of grade 1 to grade 2 and serum albumin (ALB) <30 g/L were confirmed by abdominal ultrasound examination during the screening period. Fertile men and women of childbearing age (women of childbearing age include premenopausal women and women within 2 years after menopause) are willing to sign the informed consent from the time after the last administration of the investigational drug 3 Take effective contraceptive measures (condom, contraceptive sponge, contraceptive gel, contraceptive film, intrauterine device, oral or injectable contraceptive, subcutaneous implant, etc.) within a month; Pregnancy test results must be negative for women of childbearing age within 7 days or less before the initial trial drug administration. Exclusion Criteria: People who have a known history of allergy/allergic reaction to yeast or yeast-derived products, or to any component of the study preparation; Allergic constitution (multiple drug or food allergy), or have a history of biological product allergy, other causes Had a history of severe systemic anaphylaxis and was judged by the investigator to be unsuitable for treatment with the experimental drug; At the time of screening, there were severe digestive diseases and complications that were deemed unsuitable for participation in this study by the investigators, including but not limited to malignant ascites and a diagnosis of Grade III or IV liver according to the West-Haven grading criteria Patients with encephalopathy, portal vein cancer thrombus/thrombus, circulatory dysfunction after abdominal puncture, obstructive biliary tract disease identified by ultrasound or other imaging, gastrointestinal bleeding who stopped bleeding less than 10 days after treatment or did not effectively stop bleeding after endoscopic ligation, or who were at greater risk of bleeding during the trial as assessed by the investigator (e.g., before screening) Gastroscopy within 3 months indicated severe esophageal and fundus varices with positive red sign); At the time of screening, there was a history of active cardiovascular disease or other conditions that the investigator judged unsuitable for human albumin therapy, including, but not limited to, hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg, The investigators judged that patients were well controlled and stable), severe anemia, acute heart disease, severe cardiopulmonary or structural heart disease, severe arrhythmia, decompensated heart failure (normal or high blood volume), unstable angina, and nearly 6 Myocardial infarction, medicated tachycardia/bradycardia, third-degree atrioventricular block occurred within a month; Patients with active metabolic system diseases or medical history (except diabetic patients with good blood glucose control) at the time of screening, or patients with combined renal function injury who are not suitable for serum albumin treatment according to the investigators; If there are serious underlying diseases during screening, the researchers think it is not suitable to participate in this study. These include, but are not limited to, active malignancies (including hepatocellular carcinoma [HCC]), pulmonary edema, bleeding prone or active bleeding diseases, uncontrolled infections (including active spontaneous bacterial peritonitis [SBP]), thyroid dysfunction (according to the National Cancer Institute Standard for Common Terminology for Adverse Events [NCI CTCAE] version 5.0 3 Grade and above), etc.; The patient has the following abnormalities in laboratory examination: (1). Liver function: alanine aminotransferase (ALT) > 5×ULN (upper limit of normal value); Aspartate aminotransferase (AST) >5×ULN; Serum bilirubin (TBIL) >4× the upper limit of normal (ULN) or was deemed unsuitable for trial participation by the investigator; (2) Renal function: serum creatinine >3× upper limit of normal (ULN), urine protein positive and deemed unfit for study; (3) Bone marrow function: absolute value of neutrophil (ANC) <1.0×10^9/L; Platelet (PLT) <20×10^9/L; Hemoglobin (HGB) <70 g/L; (4) Coagulation function: prothrombin time (PT) extended >5s; 7. Persons who have been treated with human plasma preparations (including human blood albumin preparations) within 7 days prior to the initial administration of the experimental drug; People with a history of organ transplantation; Those who need or plan to undergo interventional invasive testing or therapy during the study; 8. Those who have participated in or are participating in clinical trials of other new drugs or medical devices and have used investigational drugs/investigational treatments within 30 days prior to screening; 9. Those who test positive for antibodies to the human immunodeficiency virus (HIV); 10. Pregnant or lactating women; 11. Other reasons why the researcher considered it inappropriate to participate in the study.

Sites / Locations

  • Shenzhen Protgen LtdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

The experimental drug (recombinant human serum albumin injection) was administered 10 g/ day for 14 days

The experimental drug (recombinant human serum albumin injection) was administered 20 g/ day for 7 days

Control drug (human blood albumin injection) 10 g/ day for 14 days

Control drug (human blood albumin injection) 20 g/ day for 7 days

Outcomes

Primary Outcome Measures

Changes in serum albumin concentration
Change in serum albumin concentration from baseline confirmed by albumin examination immediately after completion of last intravenous administration

Secondary Outcome Measures

Ascites depth changes
Change in ascites depth from baseline after administration
Proportion of subjects with serum albumin concentration ≥35 g/L
Proportion of subjects with serum albumin concentration ≥35 g/L confirmed by albumin examination at completion of final IV administration
The time when serum albumin concentration reached ≥35 g/L
The time when serum albumin concentration reached ≥35 g/L
Abdominal circumference change
Changes in abdominal circumference from baseline after administration
Weight change
Change in body weight from baseline after administration

Full Information

First Posted
May 5, 2023
Last Updated
June 5, 2023
Sponsor
Protgen Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05858853
Brief Title
Phase II/III of Recombinant Human Serum Albumin
Official Title
To Evaluate the Effectiveness of Recombinant Human Serum Albumin Versus Human Serum Albumin in Patients With Hepatic Cirrhosis and Safety of Random, Double-blind, Parallel Grouping Phase II/III Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Protgen Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, double-blind, position-controlled, parallel group phase II/III clinical study of recombinant human serum albumin (rHSA) in cirrhotic ascites patients.
Detailed Description
This is a randomized, double-blind, position-controlled, parallel group phase II/III clinical study of recombinant human serum albumin (rHSA) in cirrhotic ascites patients. It is divided into two phases: Phase II and Phase III. In phase II, the effect of rHSA on improving serum albumin level in cirrhotic ascites patients will be evaluated with different doses and courses of treatment, and the relationship between dose and efficacy will be determined, so as to provide basis for drug administration plan and sample size calculation of phase III study. In phase III, the efficacy of rHSA will be evaluated with the change of serum albumin concentration from baseline immediately after the completion of the last intravenous administration as the main index, and its safety, PD characteristics and immunogenicity will be further evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Ascites

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
The experimental drug (recombinant human serum albumin injection) was administered 10 g/ day for 14 days
Arm Title
Group 2
Arm Type
Experimental
Arm Description
The experimental drug (recombinant human serum albumin injection) was administered 20 g/ day for 7 days
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Control drug (human blood albumin injection) 10 g/ day for 14 days
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
Control drug (human blood albumin injection) 20 g/ day for 7 days
Intervention Type
Drug
Intervention Name(s)
Recombinant Human Serum Albumin
Intervention Description
The experimental drug (recombinant human serum albumin injection) was administered 10 g/ day for 14 days
Intervention Type
Drug
Intervention Name(s)
Recombinant Human Serum Albumin
Intervention Description
The experimental drug (recombinant human serum albumin injection) was administered 20 g/ day for 7 days
Intervention Type
Drug
Intervention Name(s)
Human serum albumin
Intervention Description
Control drug (human blood albumin injection) 10 g/ day for 14 days
Intervention Type
Drug
Intervention Name(s)
Human serum albumin
Intervention Description
Control drug (human blood albumin injection) 20 g/ day for 7 days
Primary Outcome Measure Information:
Title
Changes in serum albumin concentration
Description
Change in serum albumin concentration from baseline confirmed by albumin examination immediately after completion of last intravenous administration
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Ascites depth changes
Description
Change in ascites depth from baseline after administration
Time Frame
57 days
Title
Proportion of subjects with serum albumin concentration ≥35 g/L
Description
Proportion of subjects with serum albumin concentration ≥35 g/L confirmed by albumin examination at completion of final IV administration
Time Frame
14days
Title
The time when serum albumin concentration reached ≥35 g/L
Description
The time when serum albumin concentration reached ≥35 g/L
Time Frame
57 days
Title
Abdominal circumference change
Description
Changes in abdominal circumference from baseline after administration
Time Frame
57 days
Title
Weight change
Description
Change in body weight from baseline after administration
Time Frame
57 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Agreed to follow the experimental treatment plan and visit plan, voluntarily enrolled in the group, and signed the informed consent in person; Age ≥18 years old and ≤70 years old, regardless of gender, on the date of signing the informed consent; Body mass index (BMI) was in the range of 18.0 to 29.0 kg/m2 (including boundary values); Patients clinically diagnosed with decompensated cirrhosis with ascites of grade 1 to grade 2 and serum albumin (ALB) <30 g/L were confirmed by abdominal ultrasound examination during the screening period. Fertile men and women of childbearing age (women of childbearing age include premenopausal women and women within 2 years after menopause) are willing to sign the informed consent from the time after the last administration of the investigational drug 3 Take effective contraceptive measures (condom, contraceptive sponge, contraceptive gel, contraceptive film, intrauterine device, oral or injectable contraceptive, subcutaneous implant, etc.) within a month; Pregnancy test results must be negative for women of childbearing age within 7 days or less before the initial trial drug administration. Exclusion Criteria: People who have a known history of allergy/allergic reaction to yeast or yeast-derived products, or to any component of the study preparation; Allergic constitution (multiple drug or food allergy), or have a history of biological product allergy, other causes Had a history of severe systemic anaphylaxis and was judged by the investigator to be unsuitable for treatment with the experimental drug; At the time of screening, there were severe digestive diseases and complications that were deemed unsuitable for participation in this study by the investigators, including but not limited to malignant ascites and a diagnosis of Grade III or IV liver according to the West-Haven grading criteria Patients with encephalopathy, portal vein cancer thrombus/thrombus, circulatory dysfunction after abdominal puncture, obstructive biliary tract disease identified by ultrasound or other imaging, gastrointestinal bleeding who stopped bleeding less than 10 days after treatment or did not effectively stop bleeding after endoscopic ligation, or who were at greater risk of bleeding during the trial as assessed by the investigator (e.g., before screening) Gastroscopy within 3 months indicated severe esophageal and fundus varices with positive red sign); At the time of screening, there was a history of active cardiovascular disease or other conditions that the investigator judged unsuitable for human albumin therapy, including, but not limited to, hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg, The investigators judged that patients were well controlled and stable), severe anemia, acute heart disease, severe cardiopulmonary or structural heart disease, severe arrhythmia, decompensated heart failure (normal or high blood volume), unstable angina, and nearly 6 Myocardial infarction, medicated tachycardia/bradycardia, third-degree atrioventricular block occurred within a month; Patients with active metabolic system diseases or medical history (except diabetic patients with good blood glucose control) at the time of screening, or patients with combined renal function injury who are not suitable for serum albumin treatment according to the investigators; If there are serious underlying diseases during screening, the researchers think it is not suitable to participate in this study. These include, but are not limited to, active malignancies (including hepatocellular carcinoma [HCC]), pulmonary edema, bleeding prone or active bleeding diseases, uncontrolled infections (including active spontaneous bacterial peritonitis [SBP]), thyroid dysfunction (according to the National Cancer Institute Standard for Common Terminology for Adverse Events [NCI CTCAE] version 5.0 3 Grade and above), etc.; The patient has the following abnormalities in laboratory examination: (1). Liver function: alanine aminotransferase (ALT) > 5×ULN (upper limit of normal value); Aspartate aminotransferase (AST) >5×ULN; Serum bilirubin (TBIL) >4× the upper limit of normal (ULN) or was deemed unsuitable for trial participation by the investigator; (2) Renal function: serum creatinine >3× upper limit of normal (ULN), urine protein positive and deemed unfit for study; (3) Bone marrow function: absolute value of neutrophil (ANC) <1.0×10^9/L; Platelet (PLT) <20×10^9/L; Hemoglobin (HGB) <70 g/L; (4) Coagulation function: prothrombin time (PT) extended >5s; 7. Persons who have been treated with human plasma preparations (including human blood albumin preparations) within 7 days prior to the initial administration of the experimental drug; People with a history of organ transplantation; Those who need or plan to undergo interventional invasive testing or therapy during the study; 8. Those who have participated in or are participating in clinical trials of other new drugs or medical devices and have used investigational drugs/investigational treatments within 30 days prior to screening; 9. Those who test positive for antibodies to the human immunodeficiency virus (HIV); 10. Pregnant or lactating women; 11. Other reasons why the researcher considered it inappropriate to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
dong Ji Jia, Ph.D
Phone
+010 63138339
Email
jia_jd@ccmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dong Ji Jia, Ph.D
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shenzhen Protgen Ltd
City
Guangdong
State/Province
Shenzhen
ZIP/Postal Code
10084
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jun Ya An
Phone
86+13699223097
Email
anyajun@protgen.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Phase II/III of Recombinant Human Serum Albumin

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