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

Hepatitis C, Chronic Clinical Trial

— VGX-6150-01  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027116
• Other study ID #: VGX-6150-01
• Status: Completed
• Phase: Phase 1
• First received: January 1, 2014
• Last updated: August 4, 2017
• Start date: January 2014
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: GeneOne Life Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2017
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• VGX-6150
Plasmid DNA delivered via IM injection with electroporation

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Yonsei University Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
GeneOne Life Science, Inc.	Inovio Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	To evaluate the safety and tolerability of VGX-6150 as second-line therapy in chronic hepatitis C patients.	Screening ~ week 36
Secondary	Immunogenicity and virologic response	To evaluate the immunogenicity and virologic response to VGX-6150 in treatment failure patients with chronic hepatitis C	Screening ~ Week 36