drugset / Trial / NCT02337127

Lamivudine Extending Therapy in Chronic Hepatitis B Patients After 3-year of Oral Antiviral Agents

NCT02337127

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Current treatment guidelines indicate that oral antiviral agents for HBeAg-positive chronic hepatitis B virus infection (CHB) can be stopped if the patient has undergone HBeAg seroconversion with HBV-DNA loss measured at two consecutive occasions at least 6 months apart (primary treatment endpoint). Stopping treatment can be considered if undetectable HBV-DNA has been documented on three separate occasions 6 months apart in HBeAg-negative patients. However, oral antiviral drugs currently approved for the treatment of CHB have relatively limited sustained long-term efficacy and a large proportion of patients will suffer from HBV recurrence after stopping treatment.

Timeline

Start
2011-06
Primary completion
2015-05
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lamivudine Other / unclassified 100 mg Oral