Phase II/III Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites
NCT Number: NCT06553456
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Cirrhotic Ascites
Interventions: DRUG: Recombinant Human Serum Albumin|DRUG: Human Serum Albumin
Sponsor: Protgen Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 388
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-13
Completion Date: 2025-04-30
Locations: Shenzhen Protgen Ltd, Guangdong, Shenzhen, 10084, China

Summary:
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.

Primary Outcome Measures: 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|Key Outcome Measures: The improvement rate of ascites, The improvement rate of ascites at the completion of the last intravenous administration, 7 days
Secondary Outcome Measures: The change in serum albumin concentration immediately after completion of the last intravenous dose, as confirmed by albumin testing at the local laboratory, 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