ID

35976

Description

A Study of Treatment With RO6864018 in Entecavir-Treated Patients With Chronic Hepatitis B Virus (HBV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02391805

Link

https://clinicaltrials.gov/show/NCT02391805

Keywords

Versions (1)
  1. 4/8/19 4/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT02391805

English

Eligibility Hepatitis B, Chronic NCT02391805

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 to 65 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
chronic hepatitis b infection
Description

Hepatitis B, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524909
positive test for hbsag for more than 6 months prior to randomization
Description

Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
hbsag titer greater than or equal to 250 iu/ml at screening
Description

Hepatitis B Surface Antigens Titer

Data type

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C0475208
treatment with any nucleoside/nucleotide analogue for 1 to 3 years with ongoing entecavir treatment at randomization and for at least 6 months prior to randomization
Description

Nucleoside Analogs | Nucleotide analog | entecavir

Data type

boolean

Alias
UMLS CUI [1]
C1579410
UMLS CUI [2]
C0597107
UMLS CUI [3]
C0971023
hbv dna less than 90 iu/ml or below a detection level acceptable by both the sponsor and the investigator for at least the preceding 6 months
Description

Hepatitis B DNA Measurement

Data type

boolean

Alias
UMLS CUI [1]
C3641250
hbeag positive at randomization and for at least 6 months prior to randomization
Description

Hepatitis B e antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0392390
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
documented history of hbv genotype d
Description

Hepatitis B virus genotype D

Data type

boolean

Alias
UMLS CUI [1]
C3875365
history or other evidence of bleeding from esophageal varices
Description

Bleeding esophageal varices

Data type

boolean

Alias
UMLS CUI [1]
C0155789
history of decompensated liver disease, chronic liver disease other than hbv infection, or any evidence of metabolic liver disease
Description

End Stage Liver Disease | Chronic liver disease | Exception Hepatitis B | Liver disease Metabolic

Data type

boolean

Alias
UMLS CUI [1]
C0745744
UMLS CUI [2]
C0341439
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019163
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0311400
positive test for hepatitis a, hepatitis c, or human immunodeficiency virus (hiv)
Description

Hepatitis A test positive | Hepatitis C test positive | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0560226
UMLS CUI [2]
C1609517
UMLS CUI [3]
C0019699
documented history of hepatitis d, e, or g infection
Description

Hepatitis D Infection | Hepatitis E | Hepatitis G

Data type

boolean

Alias
UMLS CUI [1]
C0011226
UMLS CUI [2]
C0085293
UMLS CUI [3]
C0814152
history of or suspicion of hepatocellular carcinoma
Description

Liver carcinoma | Suspicion Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0242114
UMLS CUI [2,2]
C2239176
history of immunologically mediated disease
Description

Disease Immune-mediated

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C4330477
history of organ transplantation
Description

Organ Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0029216
history of thyroid disease
Description

Thyroid Disease

Data type

boolean

Alias
UMLS CUI [1]
C0040128
significant acute infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
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Similar models

Eligibility Hepatitis B, Chronic NCT02391805

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 to 65 years of age
boolean
C0001779 (UMLS CUI [1])
Hepatitis B, Chronic
Item
chronic hepatitis b infection
boolean
C0524909 (UMLS CUI [1])
Hepatitis B surface antigen positive
Item
positive test for hbsag for more than 6 months prior to randomization
boolean
C0149709 (UMLS CUI [1])
Hepatitis B Surface Antigens Titer
Item
hbsag titer greater than or equal to 250 iu/ml at screening
boolean
C0019168 (UMLS CUI [1,1])
C0475208 (UMLS CUI [1,2])
Nucleoside Analogs | Nucleotide analog | entecavir
Item
treatment with any nucleoside/nucleotide analogue for 1 to 3 years with ongoing entecavir treatment at randomization and for at least 6 months prior to randomization
boolean
C1579410 (UMLS CUI [1])
C0597107 (UMLS CUI [2])
C0971023 (UMLS CUI [3])
Hepatitis B DNA Measurement
Item
hbv dna less than 90 iu/ml or below a detection level acceptable by both the sponsor and the investigator for at least the preceding 6 months
boolean
C3641250 (UMLS CUI [1])
Hepatitis B e antigen positive
Item
hbeag positive at randomization and for at least 6 months prior to randomization
boolean
C0392390 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis B virus genotype D
Item
documented history of hbv genotype d
boolean
C3875365 (UMLS CUI [1])
Bleeding esophageal varices
Item
history or other evidence of bleeding from esophageal varices
boolean
C0155789 (UMLS CUI [1])
End Stage Liver Disease | Chronic liver disease | Exception Hepatitis B | Liver disease Metabolic
Item
history of decompensated liver disease, chronic liver disease other than hbv infection, or any evidence of metabolic liver disease
boolean
C0745744 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0019163 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4,1])
C0311400 (UMLS CUI [4,2])
Hepatitis A test positive | Hepatitis C test positive | HIV Seropositivity
Item
positive test for hepatitis a, hepatitis c, or human immunodeficiency virus (hiv)
boolean
C0560226 (UMLS CUI [1])
C1609517 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Hepatitis D Infection | Hepatitis E | Hepatitis G
Item
documented history of hepatitis d, e, or g infection
boolean
C0011226 (UMLS CUI [1])
C0085293 (UMLS CUI [2])
C0814152 (UMLS CUI [3])
Liver carcinoma | Suspicion Liver carcinoma
Item
history of or suspicion of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
C0242114 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
Disease Immune-mediated
Item
history of immunologically mediated disease
boolean
C0012634 (UMLS CUI [1,1])
C4330477 (UMLS CUI [1,2])
Organ Transplantation
Item
history of organ transplantation
boolean
C0029216 (UMLS CUI [1])
Thyroid Disease
Item
history of thyroid disease
boolean
C0040128 (UMLS CUI [1])
Communicable Disease
Item
significant acute infection
boolean
C0009450 (UMLS CUI [1])
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