Chronic Hepatitis B Clinical Trial
Official title:
FINITE CHB - First Investigation in Stopping Tenofovir Disoproxil Fumarate (TDF) Treatment After Long Term Virologic Suppression in HBeAg-negative Chronic Hepatitis B
Withdrawal of antiviral therapy can result in hepatic or alanine aminotransferase (ALT)
flares as Hepatitis B Virus (HBV) replication resumes; however, in some participants, a
flare exacerbates chronic hepatitis temporarily but can also result in viral clearance.
Hepatic flares are common after stopping anti-HBV therapy.
Only participants who already are on treatment with tenofovir disoproxil fumarate (TDF)
monotherapy or TDF in combination with lamivudine or emtricitabine for at least 4 years and
who achieved and maintained virologic suppression (< 400 copies/mL) for 3.5 or more years
will be included in this study. One treatment arm will stop the TDF therapy while the other
treatment arm will continue the TDF therapy.
Participants in the Stop TDF arm will be monitored very closely with special focus on
biochemical flares (especially ALT increases) and virological relapses (Hepatitis B viral
load increases). If any participant in the Stop TDF arm exceeds one or more predefined
limits for such flares or relapses, TDF will be reinstituted.
The study will assess Hepatitis B surface antigen (HBsAg) loss (i.e. specific Hepatitis B
virus components are no longer detectable) and seroconversion (occurrence of Hepatitis B
surface antibody, a specific antibody which usually occurs after HBsAg loss) rates during
study duration. The percentage of participants who need to restart TDF therapy in the Stop
TDF arm will also be evaluated.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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