ID

29692

Description

A Study to Assess DV-601 in Subjects With Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT01023230

Link

https://clinicaltrials.gov/show/NCT01023230

Keywords

Versions (1)
  1. 4/12/18 4/12/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 12, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT01023230

English

Eligibility Hepatitis B, Chronic NCT01023230

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects 18 to 65 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
signed informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
diagnosis of chb and candidates for therapy
Description

Chronic Hepatitis B Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0332121
normal renal function
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
women of childbearing potential must have a serum negative pregnancy test at screening. women of childbearing potential and males whose sexual partners are of childbearing potential must agree to use dual methods of contraception.
Description

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods Double | Gender Sexual Partner Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0205173
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0036911
UMLS CUI [3,3]
C3831118
UMLS CUI [3,4]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
liver disease other than chb
Description

Liver disease | Exception Chronic Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0524909
documented co-infection with hepatitis a virus (hav), hepatitis c virus (hcv), or hiv
Description

HAV Coinfection | HCV coinfection | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1,1]
C0376325
UMLS CUI [1,2]
C0275524
UMLS CUI [2]
C1698259
UMLS CUI [3]
C4062778
previous therapy with interferon alpha.
Description

Alpha interferon therapy

Data type

boolean

Alias
UMLS CUI [1]
C0854621
any other antiviral therapy for chronic hepatitis b within the previous 3 months prior to screening visit.
Description

Antiviral Therapy Chronic Hepatitis B

Data type

boolean

Alias
UMLS CUI [1,1]
C0280274
UMLS CUI [1,2]
C0524909
immunosuppressive treatment (e.g. chemotherapy, high-dose of steroids) within 6 months of screening visit.
Description

Therapeutic immunosuppression | Chemotherapy | Steroids High dose

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0392920
UMLS CUI [3,1]
C0038317
UMLS CUI [3,2]
C0444956
evidence of cirrhosis
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
child-turcotte-pugh (ctp) score ≥ 7, either currently or at any occasion in the past
Description

Child-Pugh-Turcotte score

Data type

boolean

Alias
UMLS CUI [1]
C3854424
clinically significant acute or chronic illnesses, such as autoimmune diseases, collagen vascular disease, immune deficiencies, active or uncontrolled infections, etc. as determined by the investigator and documented in medical history.
Description

Illness Clinical Significance | Chronic disease | Autoimmune Diseases | Collagen-vascular disease | Immune Deficiency | Communicable Diseases | Communicable Diseases Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0008679
UMLS CUI [3]
C0004364
UMLS CUI [4]
C0262428
UMLS CUI [5]
C0021051
UMLS CUI [6]
C0009450
UMLS CUI [7,1]
C0009450
UMLS CUI [7,2]
C0205318
malignancy other than curatively treated, superficial skin cancer or carcinoma in situ of the cervix.
Description

Malignant Neoplasms | Exception Curative treatment Skin carcinoma Superficial | Exception Curative treatment Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0699893
UMLS CUI [2,4]
C0205124
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
participation in any experimental protocol or therapy within 28 days prior to the screening visit.
Description

Participation Study Protocol Investigational | Participation Therapy Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C1517586
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0949266
current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of study results.
Description

Substance Use Disorders Interfere with Protocol Compliance | Substance Use Disorders Interfere with Interpretation Research data

Data type

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0038586
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0681873
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Similar models

Eligibility Hepatitis B, Chronic NCT01023230

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female subjects 18 to 65 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Chronic Hepatitis B Treatment required for
Item
diagnosis of chb and candidates for therapy
boolean
C0524909 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Renal function
Item
normal renal function
boolean
C0232804 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods Double | Gender Sexual Partner Childbearing Potential Contraceptive methods
Item
women of childbearing potential must have a serum negative pregnancy test at screening. women of childbearing potential and males whose sexual partners are of childbearing potential must agree to use dual methods of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0205173 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0036911 (UMLS CUI [3,2])
C3831118 (UMLS CUI [3,3])
C0700589 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Liver disease | Exception Chronic Hepatitis B
Item
liver disease other than chb
boolean
C0023895 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0524909 (UMLS CUI [2,2])
HAV Coinfection | HCV coinfection | HIV coinfection
Item
documented co-infection with hepatitis a virus (hav), hepatitis c virus (hcv), or hiv
boolean
C0376325 (UMLS CUI [1,1])
C0275524 (UMLS CUI [1,2])
C1698259 (UMLS CUI [2])
C4062778 (UMLS CUI [3])
Alpha interferon therapy
Item
previous therapy with interferon alpha.
boolean
C0854621 (UMLS CUI [1])
Antiviral Therapy Chronic Hepatitis B
Item
any other antiviral therapy for chronic hepatitis b within the previous 3 months prior to screening visit.
boolean
C0280274 (UMLS CUI [1,1])
C0524909 (UMLS CUI [1,2])
Therapeutic immunosuppression | Chemotherapy | Steroids High dose
Item
immunosuppressive treatment (e.g. chemotherapy, high-dose of steroids) within 6 months of screening visit.
boolean
C0021079 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0038317 (UMLS CUI [3,1])
C0444956 (UMLS CUI [3,2])
Liver Cirrhosis
Item
evidence of cirrhosis
boolean
C0023890 (UMLS CUI [1])
Child-Pugh-Turcotte score
Item
child-turcotte-pugh (ctp) score ≥ 7, either currently or at any occasion in the past
boolean
C3854424 (UMLS CUI [1])
Illness Clinical Significance | Chronic disease | Autoimmune Diseases | Collagen-vascular disease | Immune Deficiency | Communicable Diseases | Communicable Diseases Uncontrolled
Item
clinically significant acute or chronic illnesses, such as autoimmune diseases, collagen vascular disease, immune deficiencies, active or uncontrolled infections, etc. as determined by the investigator and documented in medical history.
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2])
C0004364 (UMLS CUI [3])
C0262428 (UMLS CUI [4])
C0021051 (UMLS CUI [5])
C0009450 (UMLS CUI [6])
C0009450 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
Malignant Neoplasms | Exception Curative treatment Skin carcinoma Superficial | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
malignancy other than curatively treated, superficial skin cancer or carcinoma in situ of the cervix.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
C0205124 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
Participation Study Protocol Investigational | Participation Therapy Investigational
Item
participation in any experimental protocol or therapy within 28 days prior to the screening visit.
boolean
C0679823 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,3])
C0679823 (UMLS CUI [2,1])
C0949266 (UMLS CUI [2,2])
Substance Use Disorders Interfere with Protocol Compliance | Substance Use Disorders Interfere with Interpretation Research data
Item
current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of study results.
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0681873 (UMLS CUI [2,4])
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