ID

39568

Description

Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay; ODM derived from: https://clinicaltrials.gov/show/NCT02167113

Link

https://clinicaltrials.gov/show/NCT02167113

Keywords

Versions (1)
  1. 1/29/20 1/29/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 29, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT02167113

English

Eligibility Hepatitis B, Chronic NCT02167113

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the subject is chronically infected with hbv.the subject is treatment naïve and is initiating hbv antiviral therapy with either entecavir or tenofovir as indicated in the fda approved label
Description

Hepatitis B, Chronic | Therapy naive | Initiation HBV Antiviral Therapy | entecavir | Tenofovir

Data type

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0919936
UMLS CUI [3,1]
C1704686
UMLS CUI [3,2]
C0019169
UMLS CUI [3,3]
C0280274
UMLS CUI [4]
C0971023
UMLS CUI [5]
C0384228
the subject will be considered treatment naïve if he/she had <12 weeks of oral antiviral therapy with any nucleoside or nucleotide therapy
Description

Therapy naive | Antiviral Therapy Oral | Nucleosides | Nucleotides

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0280274
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0028621
UMLS CUI [4]
C0028630
the subject is at least 18 years of age at the time of enrollment
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria
Description

Availability of Medical Records | Patient Characteristics | Medical History | Virology | Laboratory Results

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0025102
UMLS CUI [2]
C0815172
UMLS CUI [3]
C0262926
UMLS CUI [4]
C0205466
UMLS CUI [5]
C1254595
the subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s)
Description

Informed Consent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject is in one of the following patient populations:
Description

Patient Groups

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0441833
acute hbv infection
Description

Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0019163
patients who are hbv immune tolerant
Description

Hepatitis B Virus Immune Tolerance

Data type

boolean

Alias
UMLS CUI [1,1]
C0019169
UMLS CUI [1,2]
C0020963
human immunodeficiency virus (hiv) and/or hepatitis c virus (hcv) co-infection
Description

HIV coinfection | HCV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C1698259
solid organ or bone marrow transplant recipients
Description

Solid organ transplant Recipient | Bone Marrow Transplant Recipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0730400
UMLS CUI [1,2]
C1709854
UMLS CUI [2,1]
C0005961
UMLS CUI [2,2]
C1709854
renal failure or dialysis
Description

Kidney Failure | Dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0011946
evidence or history of hepatic decompensation
Description

Hepatic decompensation

Data type

boolean

Alias
UMLS CUI [1]
C1394798
evidence or history of hepatocellular carcinoma
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
underlying liver disease other than hbv
Description

Liver disease | Exception Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019163
receiving chemotherapy, immunosuppressive agents
Description

Chemotherapy | Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021081
subject is unsuitable for study participation based on the investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication)
Description

Study Subject Participation Status Inappropriate | Protocol Compliance Unlikely | Medical complication

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0750558
UMLS CUI [3]
C0009566
participating in another investigational study that the investigator believes might interfere with the subject's participation in this study
Description

Study Subject Participation Status | Research study At risk Interference

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0681814
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0521102
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Similar models

Eligibility Hepatitis B, Chronic NCT02167113

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B, Chronic | Therapy naive | Initiation HBV Antiviral Therapy | entecavir | Tenofovir
Item
the subject is chronically infected with hbv.the subject is treatment naïve and is initiating hbv antiviral therapy with either entecavir or tenofovir as indicated in the fda approved label
boolean
C0524909 (UMLS CUI [1])
C0919936 (UMLS CUI [2])
C1704686 (UMLS CUI [3,1])
C0019169 (UMLS CUI [3,2])
C0280274 (UMLS CUI [3,3])
C0971023 (UMLS CUI [4])
C0384228 (UMLS CUI [5])
Therapy naive | Antiviral Therapy Oral | Nucleosides | Nucleotides
Item
the subject will be considered treatment naïve if he/she had <12 weeks of oral antiviral therapy with any nucleoside or nucleotide therapy
boolean
C0919936 (UMLS CUI [1])
C0280274 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0028621 (UMLS CUI [3])
C0028630 (UMLS CUI [4])
Age
Item
the subject is at least 18 years of age at the time of enrollment
boolean
C0001779 (UMLS CUI [1])
Availability of Medical Records | Patient Characteristics | Medical History | Virology | Laboratory Results
Item
adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria
boolean
C0470187 (UMLS CUI [1,1])
C0025102 (UMLS CUI [1,2])
C0815172 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C0205466 (UMLS CUI [4])
C1254595 (UMLS CUI [5])
Informed Consent | Informed Consent Patient Representative
Item
the subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s)
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Patient Groups
Item
subject is in one of the following patient populations:
boolean
C0030705 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
Hepatitis B
Item
acute hbv infection
boolean
C0019163 (UMLS CUI [1])
Hepatitis B Virus Immune Tolerance
Item
patients who are hbv immune tolerant
boolean
C0019169 (UMLS CUI [1,1])
C0020963 (UMLS CUI [1,2])
HIV coinfection | HCV coinfection
Item
human immunodeficiency virus (hiv) and/or hepatitis c virus (hcv) co-infection
boolean
C4062778 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
Solid organ transplant Recipient | Bone Marrow Transplant Recipient
Item
solid organ or bone marrow transplant recipients
boolean
C0730400 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C0005961 (UMLS CUI [2,1])
C1709854 (UMLS CUI [2,2])
Kidney Failure | Dialysis
Item
renal failure or dialysis
boolean
C0035078 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
Hepatic decompensation
Item
evidence or history of hepatic decompensation
boolean
C1394798 (UMLS CUI [1])
Liver carcinoma
Item
evidence or history of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Liver disease | Exception Hepatitis B
Item
underlying liver disease other than hbv
boolean
C0023895 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
Chemotherapy | Immunosuppressive Agents
Item
receiving chemotherapy, immunosuppressive agents
boolean
C0392920 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
Study Subject Participation Status Inappropriate | Protocol Compliance Unlikely | Medical complication
Item
subject is unsuitable for study participation based on the investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication)
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
C0009566 (UMLS CUI [3])
Study Subject Participation Status | Research study At risk Interference
Item
participating in another investigational study that the investigator believes might interfere with the subject's participation in this study
boolean
C2348568 (UMLS CUI [1])
C0681814 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
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