NCT00563173

Phase I/IIa Dose Ranging CHRONVAC-C® Study in Chronic HCV Patients

A Phase I/IIa Open-Label, Dose Ranging, Parallel, Safety, Tolerability and Efficacy Study of i.m. Administered CHRONVAC-C® in Combination With Electroporation in Chronic HCV Genotype 1 Infected and Treatment Naïve Patients With Low Viral Load

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Tripep AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate if the DNA vaccine CHRONVAC-C® intended for future treatment of Hepatitis C infections is safe and tolerated when administered to HCV infected individuals with a low viral load. In addition the capability of the vaccine to induce an immune response and the effect on viral load will be studied. In order to increase the uptake of the vaccine the intra muscular injection is combined with electroporation, meaning that a brief electric field is applied to the injection site resulting in temporary pores in the cell membranes that allows the vaccine to enter the cells.

Conditions

• Chronic Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	CHRONVAC-C®	DNA vaccine, solution for injection, i.m. administration in combination with electroporation

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2007-11-26
• Last updated: 2010-02-10

Locations

2 sites across 1 country: Sweden