protocolSection identificationModule nctId: NCT06355479, orgStudyIdInfo id: HY1001-2022-P3, briefTitle: A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-10, primaryCompletionDateStruct date: 2023-11-22, completionDateStruct date: 2023-12-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Healthgen Biotechnology Corp., class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Hypoalbuminemia, conditions: Hepatic Cirrhosis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 328, type: ACTUAL, armsInterventionsModule interventions name: OsrHSA, interventions name: Plasbumin®-20, outcomesModule primaryOutcomes measure: To evaluate the efficacy of OsrHSA on elevating the serum albumin level., secondaryOutcomes measure: To estimate the time to reach 35 g/L or more in serum albumin, secondaryOutcomes measure: To estimate the change from baseline in serum albumin, secondaryOutcomes measure: To estimate the change from baseline in colloid osmotic pressure, secondaryOutcomes measure: To estimate the change from baseline in body weight, secondaryOutcomes measure: To estimate the change from baseline in abdominal circumference, and ascites severity, secondaryOutcomes measure: To estimate the change from baseline in ascites severity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, Capital Medical University, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Youan Hospital, Capital Medical University, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Chongqing University Three Gorges Hospital, city: Chongqing, state: Chongqing, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: The Second Affiliated Hospital of Chongqing Medical University, city: Chongqing, state: Chongqing, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Mengchao Hepatobiliary Hospital of Fujian Medical University, city: Fuzhou, state: Fujian, country: China, geoPoint lat: 26.06139, lon: 119.30611, locations facility: The First Affiliated Hospital of Fujian Medical University, city: Fuzhou, state: Fujian, country: China, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Nanfang Hospital, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Third Affiliated Hospital, Sun Yat-Sen University, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Huizhou Central People's Hospital, city: Huizhou, state: Guangdong, country: China, geoPoint lat: 23.11147, lon: 114.41523, locations facility: Affiliated Hospital of Guilin Medical University, city: Guilin, state: Guangxi, country: China, geoPoint lat: 25.28194, lon: 110.28639, locations facility: Liuzhou Worker's Hospital, city: Liuzhou, state: Guangxi, country: China, locations facility: The First Affiliated Hospital of Guangxi Medical University, city: Nanning, state: Guangxi, country: China, geoPoint lat: 22.81667, lon: 108.31667, locations facility: Affiliated Hospital Of Zunyi Medical University, city: Zunyi, state: Guizhou, country: China, geoPoint lat: 27.68667, lon: 106.90722, locations facility: The Fourth Affiliated Hospital, Harbin Medical University, city: Harbin, state: Heilongjiang, country: China, geoPoint lat: 45.75, lon: 126.65, locations facility: Luoyang Central Hospital, city: Luoyang, state: Henan, country: China, geoPoint lat: 34.68361, lon: 112.45361, locations facility: The First Affiliated Hospital of Zhengzhou University, city: Zhengzhou, state: Henan, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The Sixth People's Hospital of Zhengzhou, city: Zhengzhou, state: Henan, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Jingzhou Central Hospital, city: Jingzhou, state: Hubei, country: China, geoPoint lat: 30.35028, lon: 112.19028, locations facility: TaiHe Hospital, city: Shiyan, state: Hubei, country: China, geoPoint lat: 32.6475, lon: 110.77806, locations facility: The Central Hospital of Wuhan, city: Wuhan, state: Hubei, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Wuhan Jinyintan Hospital, city: Wuhan, state: Hubei, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Yichang Central People's Hospital, city: Yichang, state: Hubei, country: China, geoPoint lat: 30.71444, lon: 111.28472, locations facility: Yueyang Central Hospital, city: Yueyang, state: Hunan, country: China, geoPoint lat: 29.37455, lon: 113.09481, locations facility: The Third People's Hospital of Zhenjiang, city: Zhenjiang, state: Jiangsu, country: China, geoPoint lat: 32.21086, lon: 119.45508, locations facility: First Affiliated Hospital of Gannan Medical University, city: Ganzhou, state: Jiangxi, country: China, locations facility: The First Affiliated Hospital of Nanchang University, city: Nanchang, state: Jiangxi, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Pingxiang People's Hospital, city: Pingxiang, state: Jiangxi, country: China, geoPoint lat: 27.61672, lon: 113.85353, locations facility: Yichun People's Hospital, city: Yichun, state: Jiangxi, country: China, geoPoint lat: 47.72143, lon: 128.87529, locations facility: Hepatobiliary Hospital Of Jilin, city: Chang chun, state: Jilin, country: China, geoPoint lat: 42.74694, lon: 126.24667, locations facility: The First Hospital of Jilin University, city: Chang chun, state: Jilin, country: China, geoPoint lat: 42.74694, lon: 126.24667, locations facility: The Sixth People's Hospital of Shenyang, city: Shenyang, state: Liaoning, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: The People's Hospital of Qinghai, city: Xining, state: Qinghai, country: China, geoPoint lat: 36.62554, lon: 101.75739, locations facility: Shandong Public Health Clinical Center, city: Jinan, state: Shandong, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: West China Hospital, Sichuan University, city: Chengdu, state: Sichuan, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: The Second Affiliated Hospital of Kunming Medical University, city: Kunming, state: Yunnan, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Ruian People's Hospital, city: Rui'an, state: Zhejiang, country: China, locations facility: The First School of Medicine, School of Information and Engineering, The First Affiliated Hospital of Wenzhou Medical University, city: Wenzhou, state: Zhejiang, country: China, geoPoint lat: 27.99942, lon: 120.66682, hasResults: False