Hepatitis B, Chronic Clinical Trial
Official title:
Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis B Infection
The purpose of this trial is to determine the safety, tolerability and effectiveness of KRN7000 for chronic hepatitis B infection.
KRN7000 is reported to inhibit HBV replication in HBV transgenic mice. Anti-viral effects of
KRN7000 can be expected in HBV, as the compound is able to induce not only IFN-alpha/beta
but also IFN-gamma and TNF-alpha. In two clinical trials, KRN7000 was safe in both healthy
volunteers and solid cancer patients; particularly, the compound has not been reported to
show drug-related serious adverse events. A phase I/II trial is of significance in assessing
the safety and efficacy of KRN7000 treatment for CHB patients.
The 300 microgram/m2 dose level, comparable to 10 microgram/kg, can be considered as the
highest safe dose level for the phase I/II trial for CHB patients with 3 dose levels. Dose
incrementation will be performed in a logarithmic manner: 0.1, 1 and 10 microgram/kg.
In the phase I trial for solid tumor patients, weekly administration of KRN7000 did not
allow sufficient time for NKT cell recovery. As KRN7000 is reported to be an activating
ligand for NKT cells, it is logical to assume that a dosing interval that provides time for
recovery of NKT cells is optimal. In fact, cytokine production after repeating dosing, when
NKT cells were hardly detected in the peripheral blood, was not observed. As it took
approximately 4 weeks for NKT cells to recover to pre-dose levels after a single
administration, monthly administration is now proposed for this trial.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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