Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum

Phase 4 Completed 40 enrolled Mylan (Taiwan) Ltd

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a phase IV, open label, historical controlled comparative study to evaluate the efficacy and safety of Ricovir® in maintaining durability of viral response in CHB patients who have been treated with Viread® and have undetectable HBV DNA in serum by real-time polymerase chain reaction (PCR) assay.

Timeline

Start: 2019-08-21
Primary completion: 2021-07-13
Completion: 2021-07-13

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenofovir disoproxil fumarate	Small molecule	300 mg	—

Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum

Summary

Timeline

Drugs

Indications