Overview

This trial is active, not recruiting.

Condition hepatitis c, chronic
Treatment vgx-6150
Phase phase 1
Sponsor GeneOne Life Science, Inc.
Collaborator Inovio Pharmaceuticals
Start date January 2014
End date July 2015
Trial size 18 participants
Trial identifier NCT02027116, VGX-6150-01

Summary

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
vgx-6150
Plasmid DNA delivered via IM injection with electroporation
(Experimental)
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
vgx-6150
Plasmid DNA delivered via IM injection with electroporation
(Experimental)
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
vgx-6150
Plasmid DNA delivered via IM injection with electroporation

Primary Outcomes

Measure
Safety and Tolerability
time frame: Screening ~ week 36

Secondary Outcomes

Measure
Immunogenicity and virologic response
time frame: Screening ~ Week 36

Eligibility Criteria

Male or female participants from 19 years up to 65 years old.

Inclusion Criteria

  • Subjects who want to participate in this trial should meet all of the following criteria.
    • Male or females aged 19 to 65 years
    • Chronic hepatitis C patients infected with HCV genotype 1a or 1b
    • 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
    • Patients whose deltoid muscles (left or right) are accessible by 12 to 19 mm cannula/ electrode for intramuscular (IM) injection and electroporation (EP)
    • Patients who can comply with planned schedule of this protocol
    • Patients who give written informed consent voluntarily

Exclusion Criteria

  • Subjects who meet any of the followings cannot participate in this study.
    • Liver transplant recipients
    • Patients having decompensated liver cirrhosis with any history or evidence of ascites, esophageal variceal hemorrhage and/or hepatic encephalopathy
    • Malignant tumor patients who received radiotherapy or chemotherapy before study participation
    • Current active infection except hepatitis C that requires medical treatment
    • Autoimmune disease patients or immunodeficient (immuno-compromised) patients
    • Patients who received immunomodulators, cytotoxic agents or systemic corticosteroids for chronic disease other than hepatitis C within 2 months before study participation
    • Patients who received non-steroidal anti-inflammatory drugs (NSAIDs) within 10 days before IP administration
    • Concomitant diseases which is judged to be unacceptable for study participation by investigator (e.g., severe cardiovascular, renal , or psychiatric disease)
    • Clinically significant abnormal findings in physical examination,laboratory tests, vital signs or ECG at investigator's discretion
  • Patients with implantable pacemaker
  • Patients with metal implant in IP administration area or nearby
  • Positive for HBsAg, or HIV Ab
  • Previous history of gene therapy
  • History of allergy or anaphylaxis to any component of IP or other vaccine
  • Patients who received major surgery within 4 weeks before IP administration
  • Blood transfusion within 4 weeks before IP administration
  • Current alcohol or drug abuse
  • Patients who received other vaccine within 30 days before IP administration
  • Pregnancy or breast-feeding woman
  • Women of childbearing potential (WOCBP) or men with partner of WOCBP who are unwilling to use adequate contraception or be abstinent during the trial
  • Patients who received other investigational products within 30 days before study participation
  • Patients incapable of participating in this trial by investigator's judgment

Additional Information

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
Principal investigator Sang Hoon Ahn, M.D, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by GeneOne Life Science, Inc..