ID

36055

Beschrijving

Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02027116

Link

https://clinicaltrials.gov/show/NCT02027116

Trefwoorden

Versies (1)
  1. 11-04-19 11-04-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 april 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT02027116

Engels

Eligibility Hepatitis C, Chronic NCT02027116

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who want to participate in this trial should meet all of the following criteria.
Beschrijving

Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. male or females aged 19 to 65 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. chronic hepatitis c patients infected with hcv genotype 1a or 1b
Beschrijving

Chronic Hepatitis C HCV genotype determination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
3. patients who failed* soc therapy with peg-ifn and ribavirin or triple therapy with soc and daa agents
Beschrijving

Standard of Care failed | PEGINTERFERON Plus Ribavirin | Triple Therapy failed | Standard of Care Plus DIRECT ACTING ANTIVIRALS

Datatype

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0982327
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0035525
UMLS CUI [3,1]
C0205174
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0231175
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C0332287
UMLS CUI [4,3]
C3653501
*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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0162643
UMLS CUI [2,1]
C1521726
UMLS CUI [2,2]
C2363763
UMLS CUI [3,1]
C3844724
UMLS CUI [3,2]
C1272251
UMLS CUI [4,1]
C0277556
UMLS CUI [4,2]
C0855841
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C1444662
UMLS CUI [5,3]
C0678226
UMLS CUI [5,4]
C0041755
4. patients whose deltoid muscles (left or right) are accessible by 12 to 19 mm cannula/ electrode for intramuscular (im) injection and electroporation (ep)
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C0694649
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0520453
UMLS CUI [2,1]
C0694666
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C0520453
UMLS CUI [3,1]
C0694649
UMLS CUI [3,2]
C3900053
UMLS CUI [3,3]
C0013812
UMLS CUI [4,1]
C0694666
UMLS CUI [4,2]
C3900053
UMLS CUI [4,3]
C0013812
UMLS CUI [5,1]
C0694649
UMLS CUI [5,2]
C3900053
UMLS CUI [5,3]
C0021492
UMLS CUI [6,1]
C0694666
UMLS CUI [6,2]
C3900053
UMLS CUI [6,3]
C0021492
UMLS CUI [7,1]
C0694649
UMLS CUI [7,2]
C3900053
UMLS CUI [7,3]
C0206691
UMLS CUI [8,1]
C0694666
UMLS CUI [8,2]
C3900053
UMLS CUI [8,3]
C0206691
5. patients who can comply with planned schedule of this protocol
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
6. patients who give written informed consent voluntarily
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who meet any of the followings cannot participate in this study.
Beschrijving

Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. liver transplant recipients
Beschrijving

Liver transplant recipient

Datatype

boolean

Alias
UMLS CUI [1]
C3811922
2. patients having decompensated liver cirrhosis with any history or evidence of ascites, esophageal variceal hemorrhage and/or hepatic encephalopathy
Beschrijving

Decompensated cirrhosis of liver | Ascites | Bleeding esophageal varices | Hepatic Encephalopathy

Datatype

boolean

Alias
UMLS CUI [1]
C1619727
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0155789
UMLS CUI [4]
C0019151
3. malignant tumor patients who received radiotherapy or chemotherapy before study participation
Beschrijving

Therapeutic radiology procedure Malignant Neoplasms | Chemotherapy Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0006826
4. current active infection except hepatitis c that requires medical treatment
Beschrijving

Communicable Disease | Exception Hepatitis C Requiremen Pharmacotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0013216
5. autoimmune disease patients or immunodeficient (immuno-compromised) patients
Beschrijving

Autoimmune Disease | Immunodeficiency | Immunocompromised patient

Datatype

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0021051
UMLS CUI [3]
C0085393
6. patients who received immunomodulators, cytotoxic agents or systemic corticosteroids for chronic disease other than hepatitis c within 2 months before study participation
Beschrijving

Immunomodulators Chronic disease | Cytotoxic agent Chronic disease | CORTICOSTEROIDS FOR SYSTEMIC USE Chronic disease | Exception Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527392
UMLS CUI [1,2]
C0008679
UMLS CUI [2,1]
C0304497
UMLS CUI [2,2]
C0008679
UMLS CUI [3,1]
C3653708
UMLS CUI [3,2]
C0008679
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0019196
7. patients who received non-steroidal anti-inflammatory drugs (nsaids) within 10 days before ip administration
Beschrijving

Anti-Inflammatory Agents, Non-Steroidal

Datatype

boolean

Alias
UMLS CUI [1]
C0003211
8. concomitant diseases which is judged to be unacceptable for study participation by investigator (e.g., severe cardiovascular, renal , or psychiatric disease)
Beschrijving

Comorbidity Unacceptable | Cardiovascular Disease Severe | Kidney Disease Severe | Mental Disorders, Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1883420
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C4046029
9. clinically significant abnormal findings in physical examination,laboratory tests, vital signs or ecg at investigator's discretion
Beschrijving

Physical examination abnormal | Laboratory test result abnormal | Abnormal vital signs | Electrocardiogram abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0747585
UMLS CUI [2]
C0438215
UMLS CUI [3]
C0277804
UMLS CUI [4]
C0522055
10. patients with implantable pacemaker
Beschrijving

Artificial cardiac pacemaker

Datatype

boolean

Alias
UMLS CUI [1]
C0030163
11. patients with metal implant in ip administration area or nearby
Beschrijving

Metallic implant

Datatype

boolean

Alias
UMLS CUI [1]
C3693688
12. positive for hbsag, or hiv ab
Beschrijving

Hepatitis B surface antigen positive | HIV antibody positive

Datatype

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0920548
13. previous history of gene therapy
Beschrijving

Gene therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0017296
14. history of allergy or anaphylaxis to any component of ip or other vaccine
Beschrijving

Hypersensitivity Component Investigational New Drugs | Anaphylaxis Component Investigational New Drugs | Hypersensitivity Component Vaccine | Anaphylaxis Component Vaccine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1705248
UMLS CUI [3,3]
C0042210
UMLS CUI [4,1]
C0002792
UMLS CUI [4,2]
C1705248
UMLS CUI [4,3]
C0042210
15. patients who received major surgery within 4 weeks before ip administration
Beschrijving

Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
16. blood transfusion within 4 weeks before ip administration
Beschrijving

Blood Transfusion

Datatype

boolean

Alias
UMLS CUI [1]
C0005841
17. current alcohol or drug abuse
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
18. patients who received other vaccine within 30 days before ip administration
Beschrijving

Vaccines

Datatype

boolean

Alias
UMLS CUI [1]
C0042210
19. pregnancy or breast-feeding woman
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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
Beschrijving

Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Sexual Abstinence Unwilling | Gender Partner Childbearing Potential | Contraceptive methods Unwilling | Sexual Abstinence Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0036899
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C3831118
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0558080
UMLS CUI [5,1]
C0036899
UMLS CUI [5,2]
C0558080
21. patients who received other investigational products within 30 days before study participation
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
22. patients incapable of participating in this trial by investigator's judgment
Beschrijving

Study Subject Participation Status Incapable

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1550518
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Similar models

Eligibility Hepatitis C, Chronic NCT02027116

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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