NCT02027116CompletedPhase 1
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
GeneOne Life Science, Inc.2 sites in 1 country18 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GeneOne Life Science, Inc.
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Safety and Tolerability
Study Overview
Brief Summary
To evaluate the safety, tolerability and immunogenicity of VGX-6150 as second-line therapy in chronic hepatitis C patients
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental: 6mg of DNA/dose
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
Intervention: VGX-6150 (Biological)
Experimental: 3mg of DNA/dose
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
Intervention: VGX-6150 (Biological)
Experimental: 1mg of DNA/dose
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
Intervention: VGX-6150 (Biological)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Immunogenicity and virologic response(Screening ~ Week 36)
Investigators
Study Sites (2)
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