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Clinical Trial Summary

This trial adopts a randomized, double-blind, positive drug-controlled, dose-escalated phase Ib clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary effectiveness of recombinant human serum albumin in patients with liver cirrhosis and ascites subjects (both male and female) were screened and enrolled to the three dose levels of 10g, 20 g,and 30 g according to the principle of dose escalation, and 8 out of 12 subjects in each dose group One patient received the test drug, and 4 received a positive drug.


Clinical Trial Description

In this Phase Ib clinical trial, randomized, double-blind, positive-controlled, dose-increasing design was employed to enroll cirrhosis ascites patients and evaluate safety, tolerability, PK characteristics, PD characteristics and preliminary efficacy at different dose levels of recombinant human serum albumin. Three dose groups (10 g/day, 20 g/day, 30 g/day) were set up in this study, and they were escalated from the lowest to the highest dosage. It is planned to enroll 12 subjects in each dose group, with 8 of 12 subjects in each dose group receiving the investigational product and 4 of 12 subjects receiving the comparator product intravenously once a day for 14 days or up to serum albumin ≥ 35 g/L ( whichever occurs first ), to investigate the safety, tolerability, immunogenicity, PK characteristics, PD characteristics and preliminary efficacy in repeated usage of recombinant human serum albumin. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05249374
Study type Interventional
Source Protgen Ltd
Contact
Status Completed
Phase Phase 1
Start date October 14, 2021
Completion date May 16, 2022

See also
  Status Clinical Trial Phase
Completed NCT06411743 - Phase II/III of Recombinant Human Albumin Injection Phase 2
Completed NCT04785755 - Effects of Adding Hypertonic Saline Solutions and/or Etilefrine to Standard Diuretics Therapy in Hepatic Ascites Phase 2
Completed NCT05858853 - Phase II/III of Recombinant Human Serum Albumin Phase 2/Phase 3
Completed NCT05179265 - Recombinant Human Serum Albumin in Healthy Subjects Phase 1