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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GeneOne Life Science, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Inovio Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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