Loading clinical trials...

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

COMPLETEDPHASE1

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

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

NCT02027116•GeneOne Life Science, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

19 - 65 years

Sex

ALL

Healthy Volunteers

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
+13 more criteria

Locations (2)

Pusan National University Hospital

Pusan, South Korea

Yonsei University Severance Hospital

Seoul, South Korea

Key Dates

Start Date

January 1, 2014

Primary Completion Date

July 1, 2015

Completion Date

July 1, 2017

Last Updated

August 7, 2017

Enrollment

ACTUAL participants

Conditions

Hepatitis C, Chronic

Interventions

VGX-6150

BIOLOGICAL

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

NCT05870969

Carcinoma, HepatocellularHepatitis C, Chronic+3 more

View study

COMPLETEDPHASE4

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

NCT03987503

Hepatitis C, Chronic

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes

Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs

The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection