Ascites Clinical Trial - Phase Ib of Recombinant Human Albumin Injection

Status Completed

Clinical Trial Summary

A Randomized, Multicenter,Open-label, positive-controlled, Multi-dose Phase 1 Study to Evaluate the Safety, Tolerance,Efficacy, Pharmacokinetics and Immunogenicity of recombinant human albumin injection in Patients With Hepatic Cirrhosis

Clinical Trial Description

This study was to evaluate the safety, tolerability,efficacy, pharmacokinetics and immunogenicity of recombinant human albumin injection in Patients With Hepatic Cirrhosis. The study design consists of two phases: Screening and treatment phase(dose increasing stage).Following the Screening phase, all eligible subjects will be randomized to receive recombinant human albumin injection or HumanAlbumin, study medication in a 3:1 ratio.Dose increasing stage (including 3 dose groups with increasing dose, and each group was set with HumanAlbumin control).The initial dose was 10g. The highest dose group was set at 30g. ;

Study Design

Related Conditions & MeSH terms

Ascites

Clinical Trial Details

NCT number	NCT04701697
Study type	Interventional
Source	First Hospital of Jilin University
Contact
Status	Completed
Phase	Phase 1
Start date	March 15, 2020
Completion date	October 25, 2020

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