The purpose of this study is to assess the optimal dose of EBP921 by comparing the efficacy and safety of 2 dose regimens in patients with chronic HDV.
This is an open-label, phase 1b, proof-of-concept study to assess the safety and efficacy of EBP921, a prenylation inhibitor, in subjects chronically infected with delta hepatitis. Subjects will be randomized to receive one of two different doses of EBP921. Dosing will occur over 28-days and during that time, evidence of antiviral response will be assessed by frequent measurements of HDV-RNA via PCR assay. In addition, safety lab data will also be collected along with surveillance monitoring of HBV activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Patients randomized to receive low or high dose. All dosing of EBP921 should be taken with food.
Unnamed facility
San Francisco, California, United States
Henry Ford Hospital
Detroit, Michigan, United States
Change in HDV-RNA
The primary efficacy endpoint will be the median change in HDV-RNA from baseline to HDV RNA nadir as measured by quantitative PCR during the 28-day dosing period.
Time frame: 28 days
Change in HDV RNA from baseline to Day 7, 14, 28 and post therapy weeks 1,2,4,8
The median change in HDV RNA from baseline to Days 7, 14, 28, and post-therapy Weeks 1, 2, 4, and 8 of the study; the proportion of patients with alanine aminotransferase (ALT) normalization defined as ALT ≤ upper limit of normal for patients with ALT \> ULN at baseline; assessment of peripheral blood mononuclear cell (PBMC) proliferation after 14 and 28 days exposure to EBP921; the percentage of patients with undetectable HDV RNA at Days 7, 14, 28, post-therapy Weeks 1, 2, 4, and 8; the median change in HBV DNA at Days 7, 14, 21, 28, 35, and 42, and HBsAg at Days 14, 28, and 42.
Time frame: 8 Weeks
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