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This trial adopts random, double-blind, positive control, parallel group design to evaluate the effectiveness and safety of recombinant human serum albumin versus human serum albumin in hepatic cirrhosis patients with ascites.
This trial adopts random, double-blind, positive control, parallel group design to evaluate the effectiveness and safety of recombinant human serum albumin versus human serum albumin in hepatic cirrhosis patients with ascites.
In this trial(phase III), the efficacy of rHSA will be evaluated by the change in serum albumin concentration immediately after the last intravenous administration from baseline, and its safety, PD characteristics and immunogenicity will be further evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | The experimental drug was administered at a dose of 20 g/ day for 7 days. |
|
| Group 2 | Active Comparator | The positive control drug was administered at a dose of 20 g/ day for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Serum Albumin | Drug | The experimental drug was administered at a dose of 20 g/ day for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of serum albumin concentration | The change in serum albumin concentration confirmed by albumin examination immediately after the completion of secondary intravenous administration compared to baseline (based on the results of central laboratory tests) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Key Secondary Outcome Measures: The improvement rate of ascites | The improvement rate of ascites at the completion of the last intravenous administration | 7 days |
| The change in serum albumin concentration immediately after completion of the last intravenous dose, as confirmed by albumin testing at the local laboratory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jidong Jia, Ph.D | Beijing Friendship Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuancheng People's Hospital | Xuancheng | Anhui | 242000 | China | ||
| Beijing Friendship Hospital, Capital Medical University |
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| Human Serum Albumin | Drug | The positive control drug was administered at a dose of 20 g/ day for 7 days. |
|
The change in serum albumin concentration confirmed by local laboratory albumin test immediately after the last intravenous administration compared to baseline |
| 7 days |
| Changes in the depth of ascites | Changes in ascites depth from baseline upon completion of the last intravenous administration | 7 days |
| The proportion of subjects with serum albumin concentration ≥ 35 g/L | The proportion of subjects whose serum albumin concentration confirmed by albumin examination at the completion of the last intravenous administration is ≥ 35 g/L | 7 days |
| The time when serum albumin concentration reached ≥35 g/L | The time when serum albumin concentration reached ≥35 g/L | 90 days |
| Changes in abdominal circumference | Changes in abdominal circumference compared to baseline at the completion of the last intravenous administration | 7 days |
| Changes in body weight | Changes in body weight compared to baseline at the completion of the last intravenous administration | 7 days |
| The change in serum albumin concentration during the re-treatment period | The change in serum albumin concentration confirmed by albumin examination immediately after the completion of the last intravenous administration during the re-treatment period compared to the baseline before the re-treatment | 7 days |
| The improvement rate of ascites during the re-treatment period | The improvement rate of ascites at the completion of the last intravenous administration during the re-treatment period | 7 days |
| Changes in the depth of ascites during the re-treatment period | Changes in ascites depth at the completion of the last intravenous administration during the re-treatment period compared to baseline before the re-treatment | 7 days |
| The proportion of subjects with serum albumin concentration ≥ 35 g/L during the re-treatment period | Proportion of subjects with serum albumin concentration ≥ 35 g/L confirmed by albumin examination during the re-treatment period | 7 days |
| The time when serum albumin concentration reached ≥35 g/L during the re-treatment period | The time when the serum albumin concentration confirmed by the albumin test during the re-treatment period reaches ≥ 35 g/L | 7 days |
| Changes in abdominal circumference during the re-treatment period | Changes in abdominal circumference at the completion of the last intravenous administration during the re-treatment period compared to baseline before the re-treatment | 7 days |
| Changes in body weight during the re-treatment period | Changes in body weight at the completion of the last intravenous administration during the re-treatment period compared to baseline before the re-treatment | 7 days |
| Beijing |
| Beijing Municipality |
| 100000 |
| China |
| Beijing YouAn Hospital, Capital Medical University | Beijing | Beijing Municipality | 100000 | China |
| Chongqing University Three Gorges Hospital | Chongqing | Chongqing Municipality | 404100 | China |
| Shunde Hospital of Southern Medical University | Foshan | Guangdong | 528000 | China |
| Guangzhou Eighth People's Hospital, Guangzhou Medical University | Guangzhou | Guangdong | 510000 | China |
| Huizhou Central People's Hospital | Huizhou | Guangdong | 516000 | China |
| Huizhou First Hospital | Huizhou | Guangdong | 516000 | China |
| Shenzhen People's Hospital | Shenzhen | Guangdong | 518000 | China |
| Shenzhen Protgen Co., Ltd. | Shenzhen | Guangdong | 518000 | China |
| Guizhou Provincial People's Hospital | Guiyang | Guizhou | 550000 | China |
| Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | 563000 | China |
| Shijiangzhuang Fifth Hospital | Shijiangzhuang | Hebei | 050000 | China |
| Hebei Medical University Third Hospital | Shijiazhuang | Hebei | 050000 | China |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150000 | China |
| The First Affiliated Hospital of Henan University | Kaifeng | Henan | China |
| Luoyang Central Hospital | Luoyang | Henan | 471000 | China |
| Luoyang Third People's Hospital | Luoyang | Henan | 471000 | China |
| Puyang Oilfield General Hospital | Puyang | Henan | 457000 | China |
| Xinyang Central Hospital | Xinyang | Henan | 464000 | China |
| People's Hospital of Zhengzhou | Zhengzhou | Henan | 450000 | China |
| The Sixth People's Hospital of Zhengzhou | Zhengzhou | Henan | 450000 | China |
| Zhengzhou Central Hospital | Zhengzhou | Henan | 450000 | China |
| Zhoukou Central Hospital | Zhoukou | Henan | 466000 | China |
| Sinopharm Dongfeng General Hospital | Shiyan | Hubei | 442000 | China |
| Taihe Hospital | Shiyan | Hubei | 442000 | China |
| The Central Hospital of Wuhan | Wuhan | Hubei | 430000 | China |
| Yichang Central People's Hospital | Yichang | Hubei | 443000 | China |
| The First People's Hospital of Changde City | Changde | Hunan | 415000 | China |
| Changsha Central Hospital | Changsha | Hunan | 410000 | China |
| The First Hospital of Hunan University of Chinese Medicine | Changsha | Hunan | 410000 | China |
| The First Hospital of Changsha | Changsha | Hunan | 410005 | China |
| First People's Hospital of Chenzhou | Chenzhou | Hunan | 423000 | China |
| Central Hospital of Hengyang | Hengyang | Hunan | 421000 | China |
| The First Affiliated Hospital of University of South China | Hengyang | Hunan | 421000 | China |
| Hunan University Of Medicine General Hospital | Huaihua | Hunan | 418000 | China |
| Loudi Central Hospital | Loudi | Hunan | 417000 | China |
| The central Hospital of Xiangtan | Xiangtan | Hunan | 411100 | China |
| Yiyang Central Hospital | Yiyang | Hunan | 413000 | China |
| The Third People's Hospital of Hunan Provincial | Yueyang | Hunan | 414000 | China |
| Zhuzhou Central Hospital | Zhuzhou | Hunan | 412000 | China |
| First Affiliated Hospital of Gannan Medical University | Ganzhou | Jiangxi | 341000 | China |
| Jiujiang NO.1 People's Hospital | Jiujiang | Jiangxi | 332000 | China |
| Jiujiang Third People's Hospital | Jiujiang | Jiangxi | 332000 | China |
| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | 330000 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330000 | China |
| The Ninth Hospital of Nanchang | Nanchang | Jiangxi | 330000 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330000 | China |
| Pingxiang No.2 People's Hospital | Pingxiang | Jiangxi | 337000 | China |
| Pingxiang People's Hospital | Pingxiang | Jiangxi | 337000 | China |
| Meihekou Central Hospital | Tonghua | Jilin | 135099 | China |
| Shandong Public Health Clinical Center | Jinan | Shandong | 250000 | China |
| The Second People's Hospital of Yibin | Yibin | Sichuan | 644000 | China |
| The First People's Hospital of Yunnan Province | Kunming | Yunnan | 650000 | China |
| The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650000 | China |
| The Third People's Hospital of Kunming city | Kunming | Yunnan | 650000 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
| The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
| The Third Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
| Wenzhou Central Hospital | Wenzhou | Zhejiang | 325000 | China |
| Zhejiang Chinese Medical University Affiliated Wenzhou Hospital of Traditional Chinese Medicine | Wenzhou | Zhejiang | 325000 | China |
| ID | Term |
|---|---|
| C501631 | recombinant human serum albumin-heme |
| D000075462 | Serum Albumin, Human |
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001798 | Blood Proteins |
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