Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection (VGX-6150-01)

August 4, 2017 updated by: GeneOne Life Science, Inc.

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

To evaluate the safety, tolerability and immunogenicity of VGX-6150 as second-line therapy in chronic hepatitis C patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Pusan, Korea, Republic of
        • Pusan National University Hospital
      • Seoul, Korea, Republic of
        • Yonsei University Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who want to participate in this trial should meet all of the following criteria.

    1. Male or females aged 19 to 65 years
    2. Chronic hepatitis C patients infected with HCV genotype 1a or 1b

    3. Patients who failed* SOC therapy with PEG-IFN and ribavirin or triple therapy with SOC and DAA agents

      *Treatment failure is defined by any of the following; A. Partial response (PR) Serum HCV RNA level declined by at least 2 log10 but still detected at treatment week 24 B. Non-response (NR) Serum HCV RNA level not declined by at least 2 log10 at treatment week 12 C. Relapse Serum HCV RNA undetected during treatment but detectable after end of treatment D. Treatment discontinuation due to ADR or other reason

    4. Patients whose deltoid muscles (left or right) are accessible by 12 to 19 mm cannula/ electrode for intramuscular (IM) injection and electroporation (EP)
    5. Patients who can comply with planned schedule of this protocol
    6. Patients who give written informed consent voluntarily

Exclusion Criteria:

  • Subjects who meet any of the followings cannot participate in this study.

    1. Liver transplant recipients
    2. Patients having decompensated liver cirrhosis with any history or evidence of ascites, esophageal variceal hemorrhage and/or hepatic encephalopathy
    3. Malignant tumor patients who received radiotherapy or chemotherapy before study participation
    4. Current active infection except hepatitis C that requires medical treatment
    5. Autoimmune disease patients or immunodeficient (immuno-compromised) patients
    6. Patients who received immunomodulators, cytotoxic agents or systemic corticosteroids for chronic disease other than hepatitis C within 2 months before study participation
    7. Patients who received non-steroidal anti-inflammatory drugs (NSAIDs) within 10 days before IP administration
    8. Concomitant diseases which is judged to be unacceptable for study participation by investigator (e.g., severe cardiovascular, renal , or psychiatric disease)
    9. Clinically significant abnormal findings in physical examination,laboratory tests, vital signs or ECG at investigator's discretion
    10. Patients with implantable pacemaker
    11. Patients with metal implant in IP administration area or nearby
    12. Positive for HBsAg, or HIV Ab
    13. Previous history of gene therapy
    14. History of allergy or anaphylaxis to any component of IP or other vaccine
    15. Patients who received major surgery within 4 weeks before IP administration
    16. Blood transfusion within 4 weeks before IP administration
    17. Current alcohol or drug abuse
    18. Patients who received other vaccine within 30 days before IP administration
    19. Pregnancy or breast-feeding woman
    20. Women of childbearing potential (WOCBP) or men with partner of WOCBP who are unwilling to use adequate contraception or be abstinent during the trial
    21. Patients who received other investigational products within 30 days before study participation
    22. Patients incapable of participating in this trial by investigator's judgment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Biological: VGX-6150
Plasmid DNA delivered via IM injection with electroporation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: Screening ~ week 36
To evaluate the safety and tolerability of VGX-6150 as second-line therapy in chronic hepatitis C patients.
Screening ~ week 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity and virologic response
Time Frame: Screening ~ Week 36
To evaluate the immunogenicity and virologic response to VGX-6150 in treatment failure patients with chronic hepatitis C
Screening ~ Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GeneOne Life Science, Inc.

Collaborators

Inovio Pharmaceuticals

Investigators

  • Principal Investigator: Sang Hoon Ahn, M.D, Ph.D., Severance Hospital
  • Principal Investigator: Jeong Heo, M.D, Ph.D., Pusan National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

January 1, 2014

First Submitted That Met QC Criteria

January 1, 2014

First Posted (Estimate)

January 3, 2014

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

August 4, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGX-6150-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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