A Phase 2 interventional study of Recombinant Human Albumin Injection and Human Albumin in Hepatic Ascites, sponsored by The First Hospital of Jilin University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by The First Hospital of Jilin University · Phase 2, Interventional, and Treatment
This study was a Phase II/III multicenter, blinded, and positiveactive-controlled clinical study with seamless adaptive design to evaluate the dose-response relationship, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites, and to provide a reference for the design of the Phase III clinical study.
This study was a Phase II/III multicenter, blinded, and positive-controlled clinical study with seamless adaptive design. The Phase II clinical study was conducted first, followed by the Phase III clinical study.The Phase II clinical study aimed to evaluate the dose-response relationship, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites, and provide a reference for the design of Phase III clinical study. Dosage: For the 10 g/day rHA injection group, the subjects were administered rHA at a dose of 10 g/day once daily for 14 days. For the 20 g/day rHA injection group, the subjects were administered rHA at a dose of 20 g/day once daily for 7 days.
252 studies on the registry are indexed under Ascites; 52 are open to participants now.
This study's enrollment of 90 is above the median of 55 across 177 interventional studies indexed under Ascites.
Browse Ascites studies →The First Hospital of Jilin University is the lead sponsor of 181 studies on the registry; 93 are open to participants now.
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Exclusion Criteria:
Recombinant Human Albumin Injection,10g/day, once daily for 14 days
Biological: Recombinant Human Albumin Injection
Recombinant Human Albumin Injection,20g/day ,once daily for 7 days
Biological: Recombinant Human Albumin Injection
Human Albumin,10g/day, once daily for 14 days
Biological: Human Albumin
Human Albumin,20g/day, once daily for 7 days
Biological: Human Albumin
Recombinant Human Albumin injection, strength: 10 g/vial (20%, 50 mL); storage conditions: 2-8°C, protected from light; manufactured and supplied by Tonghua Anrate Biopharmaceutical Co., Ltd.
Human Albumin (An Pu Lai Shi®), strength: 10 g/vial (protein concentration 20%, 50 mL/vial), storage conditions: 2-8°C, protected from light; manufactured by Shanghai RAAS Blood Products Co., Ltd.
Change from baseline in ALB
The change in ALB was determined by calculating the difference between the value measured after the last dose (immediately after the end of dosing) and the value measured before the first dose (the mean).
Time frame: Day -1/7
Proportion of subjects with serum ALB level reaching 35 g/L at the end of administration
It referred to the proportion of subjects with serum ALB level ≥ 35 g/L at the end of dosing to the total number of subjects in that dose group.
Time frame: Day 7/14
Time taken to attain serum ALB of 35 g/L
Defined as the time required from the first administration to serum ALB level ≥ 35 g/L.
Time frame: Day1- Day7/14
Change from baseline in body weight of subjects at the end of administration
Change of body weight referred to the change in body weight after the end of dosing compared with the body weight on Day -1, which served as the baseline value. Please note that the body weight should be measured without urination under fasting conditions.
Time frame: Day 7/14
Change from baseline in abdominal circumference of subjects at the end of administration
It referred to the change in abdominal circumference at the end of treatment compared with the abdominal circumference on the last day of the pre-dose observation period, which served as a reference. Please note that the abdominal circumference should be measured without urination under fasting conditions.
Time frame: Day 7/14
Change from baseline in ascites depth of participantsubjects at the end of administration
It referred to the change in ascites depth at the end of dosing compared with the ascites depth on Day -1, which served as the baseline value.
Time frame: Day 7/14
Plan to share: No — The privacy of the participants will be kept strictly confidential to the investigator, the staff participating in the study, the sponsor, and the corresponding treatment. The study protocol, records, data, and all other information generated will be kept strictly confidential.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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The First Hospital of Jilin University