Chronic Hepatitis B Clinical Trial
Official title:
Sustained Off-treatment Response After HBeAg Loss in HBeAg-Pos Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogues
This is a prospective randomized, open-label, phase IV clinical trial to learn the effects,
good and/or bad, of discontinuing or continuing nucleos(t)ide analogue (NA) treatment for 72
weeks in participants with chronic hepatitis B infection whose immune system is controlling
the amount of virus levels in the blood for at least 12 months of NA therapy.
About 66 adult men and women will participate in this study from University Health Network
which includes the Toronto Western Hospital for about 72 weeks.
Chronic infection with the hepatitis B virus (HBV) is prevalent world-wide (estimated to
affect 360 million individuals).
Chronic hepatitis b may result in progressive liver disease that leads to cirrhosis,
end-stage liver disease and hepatocellular carcinoma (HCC). Chronic hepatitis B can also be
benign and non-progressive, evolving into an inactive carrier state that rarely leads to
significant liver injury or HCC. Over the last few years, several highly effective antiviral
agents have been developed and approved for use in the treatment of chronic hepatitis B.
Current therapy of chronic hepatitis B (CHB) aims at stopping progression to cirrhosis and
hepatocellular carcinoma.
This is a prospective randomized, open-label, phase IV clinical trial to learn the effects,
good and/or bad, of discontinuing or continuing NA treatment for 72 weeks in participants
with chronic hepatitis B infection whose immune system is controlling the amount of virus
levels in the blood for at least 12 months of NA therapy.
About 66 adult men and women will participate in this study from University Health Network
which includes the Toronto Western Hospital for about 72 weeks.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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