Criteria Fulfill
Item
subjects who want to participate in this trial should meet all of the following criteria.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age
Item
1. male or females aged 19 to 65 years
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C HCV genotype determination
Item
2. chronic hepatitis c patients infected with hcv genotype 1a or 1b
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Standard of Care failed | PEGINTERFERON Plus Ribavirin | Triple Therapy failed | Standard of Care Plus DIRECT ACTING ANTIVIRALS
Item
3. patients who failed* soc therapy with peg-ifn and ribavirin or triple therapy with soc and daa agents
boolean
C2936643 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0982327 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
C0205174 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
C2936643 (UMLS CUI [4,1])
C0332287 (UMLS CUI [4,2])
C3653501 (UMLS CUI [4,3])
Treatment failure | Partial response Hepatitis C RNA decreased | Non-responsive Hepatitis C virus RNA assay | Recurrent disease Hepatitis C RNA negative | Treatment Discontinued Due to Adverse drug reaction
Item
*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
boolean
C0162643 (UMLS CUI [1])
C1521726 (UMLS CUI [2,1])
C2363763 (UMLS CUI [2,2])
C3844724 (UMLS CUI [3,1])
C1272251 (UMLS CUI [3,2])
C0277556 (UMLS CUI [4,1])
C0855841 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C0678226 (UMLS CUI [5,3])
C0041755 (UMLS CUI [5,4])
Left deltoid Amenable Cannula | Right deltoid Amenable Cannula | Left deltoid Amenable Electrode | Right deltoid Amenable Electrode | Left deltoid Amenable Intramuscular injection | Right deltoid Amenable Intramuscular injection | Left deltoid Amenable Electroporation | Right deltoid Amenable Electroporation
Item
4. patients whose deltoid muscles (left or right) are accessible by 12 to 19 mm cannula/ electrode for intramuscular (im) injection and electroporation (ep)
boolean
C0694649 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0520453 (UMLS CUI [1,3])
C0694666 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0520453 (UMLS CUI [2,3])
C0694649 (UMLS CUI [3,1])
C3900053 (UMLS CUI [3,2])
C0013812 (UMLS CUI [3,3])
C0694666 (UMLS CUI [4,1])
C3900053 (UMLS CUI [4,2])
C0013812 (UMLS CUI [4,3])
C0694649 (UMLS CUI [5,1])
C3900053 (UMLS CUI [5,2])
C0021492 (UMLS CUI [5,3])
C0694666 (UMLS CUI [6,1])
C3900053 (UMLS CUI [6,2])
C0021492 (UMLS CUI [6,3])
C0694649 (UMLS CUI [7,1])
C3900053 (UMLS CUI [7,2])
C0206691 (UMLS CUI [7,3])
C0694666 (UMLS CUI [8,1])
C3900053 (UMLS CUI [8,2])
C0206691 (UMLS CUI [8,3])
Protocol Compliance
Item
5. patients who can comply with planned schedule of this protocol
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
6. patients who give written informed consent voluntarily
boolean
C0021430 (UMLS CUI [1])
Criteria Fulfill
Item
subjects who meet any of the followings cannot participate in this study.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Liver transplant recipient
Item
1. liver transplant recipients
boolean
C3811922 (UMLS CUI [1])
Decompensated cirrhosis of liver | Ascites | Bleeding esophageal varices | Hepatic Encephalopathy
Item
2. patients having decompensated liver cirrhosis with any history or evidence of ascites, esophageal variceal hemorrhage and/or hepatic encephalopathy
boolean
C1619727 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0155789 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
Therapeutic radiology procedure Malignant Neoplasms | Chemotherapy Malignant Neoplasms
Item
3. malignant tumor patients who received radiotherapy or chemotherapy before study participation
boolean
C1522449 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Communicable Disease | Exception Hepatitis C Requiremen Pharmacotherapy
Item
4. current active infection except hepatitis c that requires medical treatment
boolean
C0009450 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0013216 (UMLS CUI [2,4])
Autoimmune Disease | Immunodeficiency | Immunocompromised patient
Item
5. autoimmune disease patients or immunodeficient (immuno-compromised) patients
boolean
C0004364 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C0085393 (UMLS CUI [3])
Immunomodulators Chronic disease | Cytotoxic agent Chronic disease | CORTICOSTEROIDS FOR SYSTEMIC USE Chronic disease | Exception Hepatitis C
Item
6. patients who received immunomodulators, cytotoxic agents or systemic corticosteroids for chronic disease other than hepatitis c within 2 months before study participation
boolean
C1527392 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
C0304497 (UMLS CUI [2,1])
C0008679 (UMLS CUI [2,2])
C3653708 (UMLS CUI [3,1])
C0008679 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0019196 (UMLS CUI [4,2])
Anti-Inflammatory Agents, Non-Steroidal
Item
7. patients who received non-steroidal anti-inflammatory drugs (nsaids) within 10 days before ip administration
boolean
C0003211 (UMLS CUI [1])
Comorbidity Unacceptable | Cardiovascular Disease Severe | Kidney Disease Severe | Mental Disorders, Severe
Item
8. concomitant diseases which is judged to be unacceptable for study participation by investigator (e.g., severe cardiovascular, renal , or psychiatric disease)
boolean
C0009488 (UMLS CUI [1,1])
C1883420 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C4046029 (UMLS CUI [4])
Physical examination abnormal | Laboratory test result abnormal | Abnormal vital signs | Electrocardiogram abnormal
Item
9. clinically significant abnormal findings in physical examination,laboratory tests, vital signs or ecg at investigator's discretion
boolean
C0747585 (UMLS CUI [1])
C0438215 (UMLS CUI [2])
C0277804 (UMLS CUI [3])
C0522055 (UMLS CUI [4])
Artificial cardiac pacemaker
Item
10. patients with implantable pacemaker
boolean
C0030163 (UMLS CUI [1])
Metallic implant
Item
11. patients with metal implant in ip administration area or nearby
boolean
C3693688 (UMLS CUI [1])
Hepatitis B surface antigen positive | HIV antibody positive
Item
12. positive for hbsag, or hiv ab
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])
Gene therapy
Item
13. previous history of gene therapy
boolean
C0017296 (UMLS CUI [1])
Hypersensitivity Component Investigational New Drugs | Anaphylaxis Component Investigational New Drugs | Hypersensitivity Component Vaccine | Anaphylaxis Component Vaccine
Item
14. history of allergy or anaphylaxis to any component of ip or other vaccine
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0002792 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C1705248 (UMLS CUI [3,2])
C0042210 (UMLS CUI [3,3])
C0002792 (UMLS CUI [4,1])
C1705248 (UMLS CUI [4,2])
C0042210 (UMLS CUI [4,3])
Major surgery
Item
15. patients who received major surgery within 4 weeks before ip administration
boolean
C0679637 (UMLS CUI [1])
Blood Transfusion
Item
16. blood transfusion within 4 weeks before ip administration
boolean
C0005841 (UMLS CUI [1])
Substance Use Disorders
Item
17. current alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Vaccines
Item
18. patients who received other vaccine within 30 days before ip administration
boolean
C0042210 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
19. pregnancy or breast-feeding woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Sexual Abstinence Unwilling | Gender Partner Childbearing Potential | Contraceptive methods Unwilling | Sexual Abstinence Unwilling
Item
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
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C3831118 (UMLS CUI [3,3])
C0700589 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C0036899 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
Investigational New Drugs
Item
21. patients who received other investigational products within 30 days before study participation
boolean
C0013230 (UMLS CUI [1])
Study Subject Participation Status Incapable
Item
22. patients incapable of participating in this trial by investigator's judgment
boolean
C2348568 (UMLS CUI [1,1])
C1550518 (UMLS CUI [1,2])