NCT04701697

Phase Ib of Recombinant Human Albumin Injection

Phase Ib Study of Recombinant Human Albumin Injection for the Treatment of Ascites in Patients With Hepatic Cirrhosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Ascites

Interventions

Type	Name	Description
DRUG	Recombinant Human Albumin Injection	Participants will receive Recombinant Human Albumin Injection of intravenous infusion
DRUG	HumanAlbumin	Participants will receive HumanAlbumin of intravenous infusion

Timeline

• Start date: 2020-03-15
• Primary completion: 2020-09-10
• Completion: 2020-10-25
• First posted: 2021-01-08
• Last updated: 2021-01-08

Locations

1 site across 1 country: China