drugset / Trial / NCT03778567

Renoprotective Effects of Telbivudine in Chronic Hepatitis B

NCT03778567

Phase 4 Completed 31 enrolled The University of Hong Kong
SequentialOpen-labelTreatment

Summary

Renal impairment is common in patients with chronic hepatitis B infection. For those taking nucleotide analogues, renal toxicity of adefovir disoproxil (ADV) and tenofovir disoproxil fumarate (TDF) is a significant concern in chronic hepatitis B (CHB) patients. Early observational clinical data suggested that telbivudine (LdT) might have renoprotective effects. In this prospective study, consecutive CHB patients on combined lamivudine (LAM)+ADV/TDF are switched to LdT+ADV/TDF at recruitment and are followed up for 24 months. Estimated glomerular filtration rate (eGFR) is calculated with the Modification of Diet in Renal Disease (MDRD) equation. The effects of LdT on cell viability and expression of kidney injury or apoptotic biomarkers are investigated in cultured renal tubular epithelial cell line HK-2.

Timeline

Start
2013-08-01
Primary completion
2016-06-16
Completion
2018-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Telbivudine Small molecule