ID

39567

Beschreibung

Study of Therapeutic Vaccination With Intensified Schedule Plus Pegasys Dual Therapy on Chronic Hepatitis B Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02097004

Link

https://clinicaltrials.gov/show/NCT02097004

Stichworte

Versionen (2)
  1. 29.01.20 29.01.20 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

29. Januar 2020

DOI

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Eligibility Hepatitis B, Chronic NCT02097004

Englisch

Eligibility Hepatitis B, Chronic NCT02097004

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age between 20 and 75 year-old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. hbsag-positive for > 6 months apart (medical history can be alternative)
Beschreibung

Hepatitis B surface antigen positive Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0149709
UMLS CUI [1,2]
C0449238
3. currently being treated with entecavir 0.5 mg/day for more than 18 months
Beschreibung

Entecavir Dose U/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0971023
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
4. undetectable hbv dna in serum (<20iu/ml) and hbeag-negative or positive for > 1year
Beschreibung

HBV DNA Undetectable | Hepatitis B e Antigens Negative Duration | Hepatitis B e antigen positive Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3641250
UMLS CUI [1,2]
C3827727
UMLS CUI [2,1]
C0019167
UMLS CUI [2,2]
C1513916
UMLS CUI [2,3]
C0449238
UMLS CUI [3,1]
C0392390
UMLS CUI [3,2]
C0449238
5. hbsag titer < 3,000 iu/ml
Beschreibung

Hepatitis B Surface Antigens Titer

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C0475208
6. alt<300 iu/l
Beschreibung

Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
7. signed written informed consent after being instructed about the objective and procedure of the clinical study
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with decompensated liver cirrhosis, any one of the following ① serum bilirubin > 3 mg/dl
Beschreibung

Decompensated cirrhosis of liver | Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1619727
UMLS CUI [2]
C1278039
② prothrombin time > 6 seconds prolonged or inr >2.3
Beschreibung

Prothrombin time increased | International Normalized Ratio

Datentyp

boolean

Alias
UMLS CUI [1]
C0151872
UMLS CUI [2]
C0525032
③ serum albumin < 2.8 g/dl
Beschreibung

Serum albumin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0523465
④ history of ascites, variceal hemorrhage, or hepatic encephalopathy
Beschreibung

Ascites | Bleeding varices | Hepatic Encephalopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2]
C0333106
UMLS CUI [3]
C0019151
⑤ child-pugh score ≥7 (child-pugh class b or c)
Beschreibung

Child-Pugh-Turcotte score | Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C3854424
UMLS CUI [2]
C2347612
2. patients who have evidence of renal insufficiency defined as serum creatinine>1.5 mg/dl
Beschreibung

Renal Insufficiency | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
3. patients with psychological problem including depression
Beschreibung

Mental problem | Depressive disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0848067
UMLS CUI [2]
C0011581
4. patients who have previous/current significant co-morbidities including congestive heart failure, chronic kidney disease, hematologic disease and malignancy including hepatocellular carcinoma(patients with malignancy cured 5 years before screening can be enrolled)
Beschreibung

Comorbidity Significant | Congestive heart failure | Chronic Kidney Disease | Hematological Disease | Malignant Neoplasms | Liver carcinoma | Exception Malignant Neoplasm Cured

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0018802
UMLS CUI [3]
C1561643
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0006826
UMLS CUI [6]
C2239176
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0006826
UMLS CUI [7,3]
C1880198
5. patients with seropositivity for anti-hcv, anti-hdv or anti-hiv
Beschreibung

Hepatitis C Antibodies Seropositive | Hepatitis D antibody Seropositive | HIV Antibodies Seropositive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0166049
UMLS CUI [1,2]
C0521143
UMLS CUI [2,1]
C0312635
UMLS CUI [2,2]
C0521143
UMLS CUI [3,1]
C0019683
UMLS CUI [3,2]
C0521143
6. patients who have excessive alcohol consumption (> 30 g/day)
Beschreibung

Alcohol intake above recommended sensible limits | Alcohol consumption U/day

Datentyp

boolean

Alias
UMLS CUI [1]
C0560219
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0456683
7. patients who have evidence of autoimmune hepatitis, hemochromatosis or wilson's disease
Beschreibung

Hepatitis, Autoimmune | Hemochromatosis | Wilson's Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0241910
UMLS CUI [2]
C0018995
UMLS CUI [3]
C0019202
8. pregnant or breast feeding females or plan for pregnancy or no contraception
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned | Gender Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
9. patients with disease may deteriorate with interferon therapy(eg, autoimmune thyroiditis)
Beschreibung

Disease Deterioration | Etiology Interferon therapy | Autoimmune thyroiditis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0868945
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0279030
UMLS CUI [3]
C0920350
10. patients who have an psoriasis
Beschreibung

Psoriasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0033860
11. patients who have history of antiviral-resistant hbv after previous treatment with oral antiviral agents
Beschreibung

Hepatitis B Virus Resistant to Antiviral Therapy | Status post Antiviral Therapy Oral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019169
UMLS CUI [1,2]
C0332325
UMLS CUI [1,3]
C0280274
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0280274
UMLS CUI [2,3]
C1527415
12. previous diagnosis with immunodeficiency or concomitant treatment of immune suppressive agent or previous organ transplantation recipients
Beschreibung

Immunodeficiency | Immunosuppressive Agents | Organ Transplantation Recipient

Datentyp

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C0021081
UMLS CUI [3,1]
C0029216
UMLS CUI [3,2]
C1709854
13. patients who have a history of hypersensitivity to study drug
Beschreibung

Hypersensitivity Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
14. uncontrollable seizure, convulsion and/or central nervous system disorders
Beschreibung

Seizure Uncontrolled | Convulsions Uncontrolled | CNS disorder Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C4048158
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0007682
UMLS CUI [3,2]
C0205318
15. patients with severe bone marrow disorder or with history of hypersensitivity to biologic agent such as vaccine.
Beschreibung

Bone Marrow Disease Severe | Hypersensitivity Biological agents | Vaccines allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005956
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0005515
UMLS CUI [3]
C0571550
16. neutrophil count < 1,500/mm3 or platelet count < 75,000/mm3 or hemoglobin < 10 g/dl
Beschreibung

Neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
17. patients with pulmonary disease (in case of history of pulmonary disease with complete recovery, enrollment is on investigator's discretion)
Beschreibung

Lung disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0024115
18. patients who have a fever ≥ 38 °c at the baseline
Beschreibung

Fever

Datentyp

boolean

Alias
UMLS CUI [1]
C0015967
19. patients who have a risk of febrile response or systemic reaction
Beschreibung

At risk Reaction febrile | At risk Systemic Reaction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C0235723
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C1710276
20. patients who the investigator deems inappropriate to participate in this study
Beschreibung

Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Ähnliche Modelle

Eligibility Hepatitis B, Chronic NCT02097004

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age between 20 and 75 year-old
boolean
C0001779 (UMLS CUI [1])
Hepatitis B surface antigen positive Duration
Item
2. hbsag-positive for > 6 months apart (medical history can be alternative)
boolean
C0149709 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Entecavir Dose U/day
Item
3. currently being treated with entecavir 0.5 mg/day for more than 18 months
boolean
C0971023 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
HBV DNA Undetectable | Hepatitis B e Antigens Negative Duration | Hepatitis B e antigen positive Duration
Item
4. undetectable hbv dna in serum (<20iu/ml) and hbeag-negative or positive for > 1year
boolean
C3641250 (UMLS CUI [1,1])
C3827727 (UMLS CUI [1,2])
C0019167 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C0392390 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Hepatitis B Surface Antigens Titer
Item
5. hbsag titer < 3,000 iu/ml
boolean
C0019168 (UMLS CUI [1,1])
C0475208 (UMLS CUI [1,2])
Alanine aminotransferase measurement
Item
6. alt<300 iu/l
boolean
C0201836 (UMLS CUI [1])
Informed Consent
Item
7. signed written informed consent after being instructed about the objective and procedure of the clinical study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Decompensated cirrhosis of liver | Serum total bilirubin measurement
Item
1. patients with decompensated liver cirrhosis, any one of the following ① serum bilirubin > 3 mg/dl
boolean
C1619727 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Prothrombin time increased | International Normalized Ratio
Item
② prothrombin time > 6 seconds prolonged or inr >2.3
boolean
C0151872 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Serum albumin measurement
Item
③ serum albumin < 2.8 g/dl
boolean
C0523465 (UMLS CUI [1])
Ascites | Bleeding varices | Hepatic Encephalopathy
Item
④ history of ascites, variceal hemorrhage, or hepatic encephalopathy
boolean
C0003962 (UMLS CUI [1])
C0333106 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
Child-Pugh-Turcotte score | Child-Pugh Classification
Item
⑤ child-pugh score ≥7 (child-pugh class b or c)
boolean
C3854424 (UMLS CUI [1])
C2347612 (UMLS CUI [2])
Renal Insufficiency | Creatinine measurement, serum
Item
2. patients who have evidence of renal insufficiency defined as serum creatinine>1.5 mg/dl
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Mental problem | Depressive disorder
Item
3. patients with psychological problem including depression
boolean
C0848067 (UMLS CUI [1])
C0011581 (UMLS CUI [2])
Comorbidity Significant | Congestive heart failure | Chronic Kidney Disease | Hematological Disease | Malignant Neoplasms | Liver carcinoma | Exception Malignant Neoplasm Cured
Item
4. patients who have previous/current significant co-morbidities including congestive heart failure, chronic kidney disease, hematologic disease and malignancy including hepatocellular carcinoma(patients with malignancy cured 5 years before screening can be enrolled)
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C1561643 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
C2239176 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0006826 (UMLS CUI [7,2])
C1880198 (UMLS CUI [7,3])
Hepatitis C Antibodies Seropositive | Hepatitis D antibody Seropositive | HIV Antibodies Seropositive
Item
5. patients with seropositivity for anti-hcv, anti-hdv or anti-hiv
boolean
C0166049 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
C0312635 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0019683 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
Alcohol intake above recommended sensible limits | Alcohol consumption U/day
Item
6. patients who have excessive alcohol consumption (> 30 g/day)
boolean
C0560219 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Hepatitis, Autoimmune | Hemochromatosis | Wilson's Disease
Item
7. patients who have evidence of autoimmune hepatitis, hemochromatosis or wilson's disease
boolean
C0241910 (UMLS CUI [1])
C0018995 (UMLS CUI [2])
C0019202 (UMLS CUI [3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Gender Contraceptive methods Absent
Item
8. pregnant or breast feeding females or plan for pregnancy or no contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Disease Deterioration | Etiology Interferon therapy | Autoimmune thyroiditis
Item
9. patients with disease may deteriorate with interferon therapy(eg, autoimmune thyroiditis)
boolean
C0012634 (UMLS CUI [1,1])
C0868945 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0279030 (UMLS CUI [2,2])
C0920350 (UMLS CUI [3])
Psoriasis
Item
10. patients who have an psoriasis
boolean
C0033860 (UMLS CUI [1])
Hepatitis B Virus Resistant to Antiviral Therapy | Status post Antiviral Therapy Oral
Item
11. patients who have history of antiviral-resistant hbv after previous treatment with oral antiviral agents
boolean
C0019169 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0280274 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0280274 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
Immunodeficiency | Immunosuppressive Agents | Organ Transplantation Recipient
Item
12. previous diagnosis with immunodeficiency or concomitant treatment of immune suppressive agent or previous organ transplantation recipients
boolean
C0021051 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0029216 (UMLS CUI [3,1])
C1709854 (UMLS CUI [3,2])
Hypersensitivity Investigational New Drugs
Item
13. patients who have a history of hypersensitivity to study drug
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Seizure Uncontrolled | Convulsions Uncontrolled | CNS disorder Uncontrolled
Item
14. uncontrollable seizure, convulsion and/or central nervous system disorders
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C4048158 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0007682 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Bone Marrow Disease Severe | Hypersensitivity Biological agents | Vaccines allergy
Item
15. patients with severe bone marrow disorder or with history of hypersensitivity to biologic agent such as vaccine.
boolean
C0005956 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0005515 (UMLS CUI [2,2])
C0571550 (UMLS CUI [3])
Neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
16. neutrophil count < 1,500/mm3 or platelet count < 75,000/mm3 or hemoglobin < 10 g/dl
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Lung disease
Item
17. patients with pulmonary disease (in case of history of pulmonary disease with complete recovery, enrollment is on investigator's discretion)
boolean
C0024115 (UMLS CUI [1])
Fever
Item
18. patients who have a fever ≥ 38 °c at the baseline
boolean
C0015967 (UMLS CUI [1])
At risk Reaction febrile | At risk Systemic Reaction
Item
19. patients who have a risk of febrile response or systemic reaction
boolean
C1444641 (UMLS CUI [1,1])
C0235723 (UMLS CUI [1,2])
C1444641 (UMLS CUI [2,1])
C1710276 (UMLS CUI [2,2])
Study Subject Participation Status Inappropriate
Item
20. patients who the investigator deems inappropriate to participate in this study
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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