Chronic Hepatitis B Clinical Trial
Official title:
Phase IIII Study of a Therapeutic Vaccine Candidate Containing Hepatitis B Virus (HBV) Core Antigen (HBcAg) and HBV Surface Antigen (HBsAg) for Treatment of Patients With Chronic HBV Infection
The general objective of the present clinical trial is to compare the therapeutic efficacy of a combination therapeutic vaccine containing hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) [later called NASVAC] with a commonly used antiviral drug, pegylated interferon in patients with chronic hepatitis B (CHB).
To collect and assess data on the therapeutic potential of the NASVAC in CHB patients
regarding:
Reduction of the serum HBV DNA levels. Reduction in the levels of alanine aminotransferase
(ALT) Clearance of hepatitis B e antigen (HBeAg) Negativation or lowering of HBsAg
Anti-HBsAg/anti-HBeAg seroconversion
An additional objective of this study is to reconfirm the safety of NASVAC in CHB patients
that has previously been shown by us in Phase I-II clinical trial in CHB patients.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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