REP 2139-Mg and REP 2165-Mg Combination Therapy in Chronic Hepatitis B Infection
Status:
Completed
Trial end date:
2019-05-01
Target enrollment:
Participant gender:
Summary
NAPs have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both
preclinically (in duck HBV infected ducks) and in human patients. REP 2139-Ca mediated HBsAg
clearance acts synergistically with immunotherapeutic agent pegylated interferon-alpha 2a to
restore host immunological control of HBV infection. REP 2165 is a version of REP 2139 which
has been shown preclinically to retain antiviral activity with lower accumulation in the
liver.
Both REP 2139 and REP 2165 used in this protocol are formulated as magnesium chelate
complexes, which improve their administration tolerability. This open label, randomized and
controlled study will examine the safety and efficacy of REP 2139-Mg and REP 2165-Mg therapy
in patients with HBeAg negative chronic hepatitis B when used in combination with tenofovir
disoproxil fumarate and pegylated interferon alpha-2a.