drugset / Trial / NCT02338674

TDF and LdT in Immune-tolerant CHB Patients Awaiting Assisted Reproduction

NCT02338674

Phase 1/2 Completed 121 enrolled Fuzhou General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Immune-tolerant patients with chronic hepatitis B (CHB) awaiting assisted reproduction (AR) are required to initiate antiviral therapy due to laboratory safety. Additionally, rapid virus elimination is suggested to faciliate timely performance of AR. However, no consensus is reached regarding the antiviral therapy in this group. This study aimed to explore the efficacy and safety of tenofovir (TDF) and telbivudine (LdT) in this population.

Timeline

Start
2014-10
Primary completion
2016-10
Completion
2017-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Telbivudine Small molecule
Comparator Tenofovir Small molecule