A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia
A Phase 3 Randomized, Double-blind, Active-controlled Multi-center Study to Evaluate the Efficacy, Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia
1 other identifier
interventional
328
1 country
37
Brief Summary
The goal of this clinical trial is to evaluate the efficacy of OsrHSA works to treat hypoalbuminemia in hepatic cirrhosis patients. It will also learn about the safety and immunogenicity of OsrHSA. The main question it aims to answer is whether OsrHSA is effective in elevating the serum albumin level of cirrhotic patients with hypoalbuminemia. Researchers will compare OsrHSA to the positive comparator, plasma-derived HSA (pHSA) to see if OsrHSA presents as non-inferior to pHSA in the indication of hypoalbuminemia in hepatic cirrhosis patients. Participants will be randomized in a 1:1 ratio to receive OsrHSA or HpHSA (20g IV qd) for up to 14 days, following an EOT visit. Follow-up visits will be taken on EOT+7d, EOT+14d, and EOT+30d, respectively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2023
Shorter than P25 for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2023
CompletedFirst Submitted
Initial submission to the registry
March 21, 2024
CompletedFirst Posted
Study publicly available on registry
April 9, 2024
CompletedApril 9, 2024
April 1, 2024
8 months
March 21, 2024
April 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of OsrHSA on elevating the serum albumin level.
Percentage of participants whose albumin level reaches 35 g/L or above at any time up to 14 days of the study intervention.
Day 1 to Day 14
Secondary Outcomes (6)
To estimate the time to reach 35 g/L or more in serum albumin
Day 1 to Day 14
To estimate the change from baseline in serum albumin
Day 1 to Day 14
To estimate the change from baseline in colloid osmotic pressure
Day 1 to Day 14
To estimate the change from baseline in body weight
Day 1 to Day 14
To estimate the change from baseline in abdominal circumference, and ascites severity
Day 1 to Day 14
- +1 more secondary outcomes
Study Arms (2)
OsrHSA
EXPERIMENTALOsrHSA 20g, IV qd, Day1 up to Day 14
pHSA
ACTIVE COMPARATORpHSA 20g, IV qd, Day1 up to Day 14
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of hepatic cirrhosis
- Adult males or females, aged 18-75 years (both inclusive) at the time of consent
- Serum albumin level ≤ 30 g/L
- Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol
You may not qualify if:
- History of allergy to rice; a history of allergy to any component of the HpHSA product
- Therapeutic/ Large-volume paracentesis (\> 5L each time) during the treatment period
- Ascites resulted from non-hepatic cirrhosis, Budd-Chiari syndrome
- Participants with Grade III or Grade IV hepatic encephalopathy using West Heaven Criteria
- A transjugular intrahepatic peritoneal shunt (TIPS) is performed within 1 month prior to the first dosing
- Evidence of upper gastrointestinal hemorrhage 6 months prior to the first dosing
- Participants with stage C and stage D hepatocellular carcinoma according to China Liver Cancer Staging (CNLC) Classification
- Evidence of extrahepatic neoplastic disorders
- Transplantation
- HIV positive
- Participants with pleural effusion and need therapeutic thoracentesis during the treatment period
- Uncontrolled infection with body temperature ≥ 38.5 degrees Celsius (101.3 degrees Fahrenheit) or ≤ 35 degrees Celsius (95 degrees Fahrenheit) and white blood cells \> 12.0×10\^9/L. i.e. severe intraabdominal infections, sepsis, respiratory tract infections, urine tract infections.
- Other serious underlying diseases, including but not limited to: hepatopulmonary syndrome, heart failure grade III-IV (NYHA scale of heart function), severe structural heart disease, symptomatic ischemic heart disease, severe chest and lung disease, hemodialysis, active biliary obstructive disease, etc.
- With the following abnormal laboratory test values:
- Hematology: white blood cell count \< 2.0×10\^9/L, absolute neutrophil count \< 1.0×10\^9/L, platelets \< 30×10\^9/L, or hemoglobin \< 75 g/L; Chemistry: ALT and/or AST \> 5× upper limit of normal (ULN), total bilirubin \> 3× ULN; Coagulation: INR\>2.0; Renal function: Cr \> 2×ULN, urine protein \>2+; Echocardiography: LVEF \< 50%
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Nanfang Hospital
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Liuzhou Worker's Hospital
Liuchow, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Affiliated Hospital Of Zunyi Medical University
Zunyi, Guizhou, China
The Fourth Affiliated Hospital, Harbin Medical University
Harbin, Heilongjiang, China
Luoyang Central Hospital
Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
TaiHe Hospital
Shiyan, Hubei, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
Wuhan Jinyintan Hospital
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Yueyang Central Hospital
Yueyang, Hunan, China
The Third People's Hospital of Zhenjiang
Zhenjiang, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Yichun People's Hospital
Yichun, Jiangxi, China
Hepatobiliary Hospital Of Jilin
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, China
The People's Hospital of Qinghai
Xining, Qinghai, China
Shandong Public Health Clinical Center
Jinan, Shandong, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Ruian People's Hospital
Rui’an, Zhejiang, China
The First School of Medicine, School of Information and Engineering, The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2024
First Posted
April 9, 2024
Study Start
April 10, 2023
Primary Completion
November 22, 2023
Study Completion
December 12, 2023
Last Updated
April 9, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share