Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects

NCT05249374 | Completed Phase 1

• 1 other identifier: rHSA 2020-2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 8

Brief Summary

This trial adopts a randomized, double-blind, positive drug-controlled, dose-escalated phase Ib clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary effectiveness of recombinant human serum albumin in patients with liver cirrhosis and ascites subjects (both male and female) were screened and enrolled to the three dose levels of 10g, 20 g,and 30 g according to the principle of dose escalation, and 8 out of 12 subjects in each dose group One patient received the test drug, and 4 received a positive drug.

Conditions

Hepatic Ascites

Outcome Measures

Primary Outcomes (2)

• TEAE

  Adverse events will be coded using MedDRA (International Dictionary of Medical Terms)., TEAEs related to test drugs were summarized and analyzed according to SOC and PT, and the number of occurrences and the incidence were calculated.

  57 days

• SAE

  Adverse events will be coded using MedDRA (International Dictionary of Medical Terms). SAEs related to test drugs were summarized and analyzed according to SOC and PT, and the number of occurrences and the incidence were calculated.

  57 days

Secondary Outcomes (11)

• AUC0-last

  57 days

• Pharmacokinetic characteristics

  57 day

• Albumin concentration of D15

  1 day

• Albumin concentration of D29

  1 day

• Albumin concentration of D57

  1 day

Study Arms (2)

Control group

ACTIVE COMPARATOR

10 g/ bottle (20%, 50 mL)

Drug: Recombinant Human Serum Albumin

test group

EXPERIMENTAL

10 g/bottle (20%, 50 mL)

Drug: Human serum albumin

Interventions

Recombinant Human Serum Albumin DRUG

10 g/bottle (20%, 50 mL)

Control group

Human serum albumin DRUG

10 g/bottle (20%, 50 mL)

test group

Eligibility Criteria

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

You may qualify if:

• Agree to follow the experimental treatment plan and visit plan, voluntarily enroll in the group, and sign the informed consent in person;
• Age ≥18 years old and \<65 years old on the day of signing the informed consent, no gender limitation; Body mass index (BMI) ranged from 18.0 kg/m2 to 29.0 kg/m2 (including boundary values);
• Patients clinically diagnosed as decompensated cirrhotic ascites with ascites grade 1-2 and serum albumin (ALB) \<30 g/L confirmed by abdominal ultrasonography during screening period;
• Men and women of child-bearing age with fertility (childbearing age women including premenopausal women and 2 years after menopause women) from willing to sign a consent form began to experiment with drugs within 3 months after the last delivery effective precautions (take a condom, contraceptive sponge, contraceptive gel, diaphragm, intrauterine device, oral or injectable contraceptives, subcutaneous preparetions Agent, etc.); Women of reproductive age must have a negative pregnancy test no later than 7 days before the first investigational drug is administered.

You may not qualify if:

• Patients with malignant ascites;
• People who have a known history of allergy/allergic reaction to yeast or yeast-derived products or are allergic to any component of the study product; Patients with an allergic constitution (multiple drug or food allergy), a history of allergic to biological products, or a history of severe systemic allergic reaction caused by other reasons, and the investigator judges that they are not suitable for treatment with experimental drugs;
• The patient has the following abnormal laboratory tests:
• Bone marrow function: absolute value of neutrophils (ANC) \<1.0×109/L (1000/mm3); Platelet (PLT) \<20×109/L (2×104/mm3); Hemoglobin (HGB) \<7.0 g/dL;Liver function: alanine aminotransferase (ALT) \> 5×ULN (upper normal value); Aspartate aminotransferase (AST) \> 5×ULN; Serum bilirubin (T-Bil) \>3× upper normal value (ULN);Renal function: serum creatinine \>2× upper normal value (ULN); Positive urine protein and ineligible to participate in the test judged by the investigator; coagulation function: prothrombin activity \<40%;
• Active cardiovascular disease or history at the time of screening, or other conditions that the investigator determined were not suitable for human serum albumin therapy, including but not limited to hypertension (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg), Researchers determine drug control is good and stable condition except), severe anemia, heart disease, acute severe lung or structural heart disease, severe arrhythmia, normal blood volume (or high blood volume) of decompensated heart failure, unstable angina, nearly six months prior to screening the myocardial infarction, require drug treatment of tachycardia/slow, three degree atrioventricular block, etc.;
• At the time of screening, there was a history of active metabolic system disease or other renal injury that the investigator determined was unsuitable for serum albumin treatment, including but not limited to renal/postrenal anuria, hepatorenal syndrome (HRS), chronic kidney disease, hepatitis B related nephropathy, etc.;
• Patients with the following active concurrent diseases during screening, including but not limited to, Pulmonary edema, bleeding tendency, or active bleeding disease, sustained or active infection (including active spontaneous bacterial peritonitis (SBP)), according to West - Haven classification standard diagnosis of hepatic encephalopathy grade III or IV level, portal venous tumor emboli/blood clots, circulation dysfunction after abdominal puncture, ultrasound and other imaging examination of biliary obstructive disease Disease, thyroid dysfunction (grade 3 and above according to NCI CTCAE version 5.0);
• Patients with previous history of upper gastrointestinal bleeding within 1 month or gastrointestinal bleeding within 3 months (≥2 times) or high risk of bleeding during the study as assessed by the investigator;
• Patients with active malignancies (including hepatocellular carcinoma \[HCC\]) at the time of screening, or with a history of malignant tumors within 5 years (except cancer in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ and other very low-risk malignancies of cervical or breast cancer undergoing curative treatment);
• Those who have received corticosteroids or human plasma preparations (including human serum albumin preparations) within 20 days prior to the first administration of the investigational drug; Those with a history of organ transplantation; Those requiring or planning to undergo invasive tests or treatment during the study period;
• Participating in or participating in clinical trials of other new drugs or medical devices and using investigational drugs/investigational treatments within 30 days prior to screening; Prior participation in clinical trials of recombinant human serum albumin;
• HIV antibody test positive, or syphilis (defined as positive syphilis antibody test and positive retin test);
• Pregnant or lactating women;
• Other reasons that the researcher considers inappropriate to participate in this study.

Sponsors & Collaborators

• Protgen Ltd: lead

Study Sites (8)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

Location

Shenzhen Protgen Co., Ltd.

Shenzhen, Guangdong, 100084, China

Location

Shenzhen Third People's Hospital

Shenzhen, Guangdong, 518000, China

Location

Hebei Petro China Central Hospital

Shijiazhuang, Hebei, 050000, China

Location

The First Hospital of Changsha

Changsha, Hunan, 410005, China

Location

Yiyang Central Hospital

Yiyang, Hunan, 413000, China

Location

Pingxiang People's Hospital

Pingxiang, Jiangxi, 337000, China

Location

Yichun People's Hospital

Yichun, Jiangxi, 336000, 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

• Rui Chen, Ph.D

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 21, 2022
• Study Start: October 14, 2021
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)