NCT05249374

Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects

A Randomized, Double-blind, Active Drug-controlled, Dose-escalation Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of r-HSA in Patients With Cirrhosis and Ascites

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Protgen Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hepatic Ascites

Interventions

Type	Name	Description
DRUG	Recombinant Human Serum Albumin	10 g/bottle (20%, 50 mL)
DRUG	Human serum albumin	10 g/bottle (20%, 50 mL)

Timeline

• Start date: 2021-10-14
• Primary completion: 2022-05-16
• Completion: 2022-05-16
• First posted: 2022-02-21
• Last updated: 2026-03-11

Locations

8 sites across 1 country: China