Phase II/III of Recombinant Human Serum Albumin

NCT05858853 | Completed Phase 2

• 1 other identifier: rHSA 2020-3（Phase Ⅱ）
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 25

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.

Conditions

Cirrhotic Ascites

Outcome Measures

Primary Outcomes (1)

• Changes in serum albumin concentration

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

  14 days

Secondary Outcomes (5)

• Ascites depth changes

  57 days

• Proportion of subjects with serum albumin concentration ≥35 g/L

  14days

• The time when serum albumin concentration reached ≥35 g/L

  57 days

• Abdominal circumference change

  57 days

• Weight change

  57 days

Study Arms (4)

Group 1

EXPERIMENTAL

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

Drug: Recombinant Human Serum Albumin

Group 2

EXPERIMENTAL

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

Drug: Recombinant Human Serum Albumin

Group 3

ACTIVE COMPARATOR

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

Drug: Human serum albumin

Group 4

ACTIVE COMPARATOR

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

Drug: Human serum albumin

Interventions

Recombinant Human Serum Albumin DRUG

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

Group 1

Human serum albumin DRUG

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

Group 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Protgen Ltd: lead

Study Sites (25)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Shunde Hospital of Southern Medical University

Foshan, Guangdong, 528000, China

Location

Guangzhou Eighth People's Hospital, Guangzhou Medical University (Department of Hepatology)

Guangzhou, Guangdong, 510000, China

Location

Shenzhen Protgen Co., Ltd.

Shenzhen, Guangdong, 518000, China

Location

Xinyang Central Hospital

Xinyang, Henan, 464000, China

Location

People's Hospital of Zhengzhou

Zhengzhou, Henan, 450000, China

Location

The Sixth People's Hospital of Zhengzhou

Zhengzhou, Henan, 450000, China

Location

The First People's Hospital of Changde City (Department of Infectious Diseases)

Changde, Hunan, 415000, China

Location

The First People's Hospital of Changde City(Department of Gastroenterology)

Changde, Hunan, 415000, China

Location

The First Hospital of Changsha

Changsha, Hunan, 410005, China

Location

The Affiliated Hospital of Xiangnan University

Chenzhou, Hunan, 423000, China

Location

Central Hospital of Hengyang

Hengyang, Hunan, 421000, China

Location

The First Affiliated Hospital of University of South China (Department of Infectious Diseases)

Hengyang, Hunan, 421000, China

Location

The First Affiliated Hospital of University of South China(Department of Gastroenterology)

Hengyang, Hunan, 421000, China

Location

Yiyang Central Hospital

Yiyang, Hunan, 413000, China

Location

Yueyang Central Hospital

Yueyang, Hunan, 414000, China

Location

Zhuzhou Central Hospital

Zhuzhou, Hunan, 412000, China

Location

The Ninth Hospital of Nanchang

Nanchang, Jiangxi, 330000, China

Location

Pingxiang No.2 People's Hospital

Pingxiang, Jiangxi, 337000, China

Location

Pingxiang People's Hospital

Pingxiang, Jiangxi, 337000, China

Location

Meihekou Central Hospital

Tonghua, Jilin, 135099, China

Location

Shandong Public Health Clinical Center

Jinan, Shandong, 250000, China

Location

Linfen Central Hospital

Linfen, Shanxi, 041000, China

Location

MeSH Terms

Interventions

recombinant human serum albumin-heme; Serum Albumin, Human

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Officials

• Jidong Jia, Ph.D

  Beijing Friendship Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 15, 2023
• Study Start: May 24, 2023
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (25)