drugset / Trial / NCT04543565

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

NCT04543565

Phase 3 Unknown 900 enrolled Xi'an Xintong Pharmaceutical Research Co.,Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2020-09
Primary completion
2022-10
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tenofovir disoproxil fumarate Small molecule
Subject pradefovir Small molecule