Clinical Trial: Proof-of-concept Study Evaluating the Safety and Efficacy of EBP921 in Delta Hepatitis (HDV)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: An Open Label, Dose-ranging Proof-of-concept Study Assessing the Safety and Efficacy of EBP921 in Therapy-naive Patients Chronically Infected With Delta Hepatitis (HDV)
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Eiger BioPharmaceuticals
Current Primary Outcome: Change in HDV-RNA [ Time Frame: 28 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Change in HDV RNA from baseline to Day 7, 14, 28 and post therapy weeks 1,2,4,8 [ Time Frame: 8 Weeks ]
Original Secondary Outcome: Same as current
Information By: Eiger BioPharmaceuticals
Dates:
Date Received: March 14, 2011
Date Started: January 2011
Date Completion:
Last Updated: August 4, 2016
Last Verified: August 2016