A Phase 1 interventional study of EBP921 in Hepatitis D, sponsored by Eiger BioPharmaceuticals. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-08.
Sponsored by Eiger BioPharmaceuticals · Phase 1, Interventional, and Treatment
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.
82 studies on the registry are indexed under Hepatitis D; 24 are open to participants now.
This study's enrollment of 3 is below the median of 55 across 38 interventional studies indexed under Hepatitis D.
Browse Hepatitis D studies →Eiger BioPharmaceuticals is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
16. Patients with a history of multiple drug resistant HBV 17. Patients receiving interferon therapy for any reason.
Low Dose for 28 days: n=4
Drug: EBP921
High Dose for 28 days; n=4
Drug: EBP921
Patients randomized to receive low or high dose. All dosing of EBP921 should be taken with food.
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
This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Eiger BioPharmaceuticals