Inovio Pharmaceuticals Inc (INO)

[biovalidator]

HEP C http://clinicaltrials.gov/ct2/show/NCT02027116?term=vgx&rank=1

To Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Chronic Hepatitis C Infection (VGX-6150-01)
This study is not yet open for participant recruitment.
Verified January 2014 by VGX International, Inc.
Sponsor:
VGX International, Inc.
Collaborator:
Inovio Pharmaceuticals
Information provided by (Responsible Party):
VGX International, Inc.
ClinicalTrials.gov Identifier:
NCT02027116
First received: January 1, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
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Purpose
To evaluate the safety, tolerability and immunogenicity of VGX-6150 as second-line therapy in chronic hepatitis C patients


Condition Intervention Phase
Hepatitis C, Chronic
Biological: VGX-6150
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center, Open-label, Dose Escalation, Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C
Drug Information available for: Deoxyribonucleic acid Hepatitis A Vaccines
U.S. FDA Resources

Further study details as provided by VGX International, Inc.:

Primary Outcome Measures:
Safety and Tolerability [ Time Frame: Screening ~ week 36 ] [ Designated as safety issue: Yes ]
To evaluate the safety and tolerability of VGX-6150 as second-line therapy in chronic hepatitis C patients.


Secondary Outcome Measures:
Immunogenicity and virologic response [ Time Frame: Screening ~ Week 36 ] [ Designated as safety issue: No ]
To evaluate the immunogenicity and virologic response to VGX-6150 in treatment failure patients with chronic hepatitis C


Estimated Enrollment: 18
Study Start Date: January 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental: 1mg of DNA/dose
Subjects will receive a 3 dose series of VGX-6150 containing 1mg DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8, Week 12
Biological: VGX-6150
Plasmid DNA delivered via IM injection with electroporation
Experimental: Experimental: 3mg of DNA/dose
Subjects will receive a 3 dose series of VGX-6150 containing 3mg DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8, Week 12
Biological: VGX-6150
Plasmid DNA delivered via IM injection with electroporation
Experimental: Experimental: 6mg of DNA/dose
Subjects will receive a 3 dose series of VGX-6150 containing 6mg DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8, Week 12