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Phase Ib of Recombinant Human Albumin Injection

NCT04701697 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-01-08

No results posted yet for this study

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

Conditions

  • Ascites

Interventions

DRUG

Recombinant Human Albumin Injection

Participants will receive Recombinant Human Albumin Injection of intravenous infusion

DRUG

HumanAlbumin

Participants will receive HumanAlbumin of intravenous infusion

Sponsors & Collaborators

  • The First Hospital of Jilin University

    lead OTHER

Principal Investigators

  • Junqi Niu, Dr · The first affiliated hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-15
Primary Completion
2020-09-10
Completion
2020-10-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04701697 on ClinicalTrials.gov