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Proof-of-concept Study Evaluating the Safety and Efficacy of EBP921 in Delta Hepatitis (HDV)

Hepatitis D Clinical Trial

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)

Clinical Trial 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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01316185
Study type Interventional
Source Eiger BioPharmaceuticals
Contact
Status Terminated
Phase Phase 1
Start date January 2011
Completion date April 2013
View Details
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