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Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study

NCT04543565 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2020-09-10

No results posted yet for this study

Summary

This is a phase three study to evaluate the safety and efficacy of Pradefovir treatment in chronic hepatitis B patients. Subject will be randomized to Pradefovir group and TDF group at a ratio of 2:1. Treatment duration will be 96w in randomization and followed by 48w in open. The interim analysis will be conducted when all subject completed the first 48-week treatment.

Conditions

Interventions

DRUG

Pradefovir Mesylate;Placebo of Tenofovir disoproxil fumarate tablet

Once daily

DRUG

Tenofovir disoproxil fumarate tablet;Placebo of Pradefovir Mesylate

Once daily

Sponsors & Collaborators

  • Xi'an Xintong Pharmaceutical Research Co.,Ltd.

    lead OTHER

Principal Investigators

  • Junqi Niu, Dr. · The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2022-10-31
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04543565 on ClinicalTrials.gov