ID

39568

Beschreibung

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

Stichworte

Versionen (1)
  1. 29.01.20 29.01.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

29. Januar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT02167113

Englisch

Eligibility Hepatitis B, Chronic NCT02167113

1 Formulare  
Inclusion Criteria
Beschreibung

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
Beschreibung

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

Datentyp

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
Beschreibung

Therapy naive | Antiviral Therapy Oral | Nucleosides | Nucleotides

Datentyp

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
Beschreibung

Age

Datentyp

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
Beschreibung

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

Datentyp

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)
Beschreibung

Informed Consent | Informed Consent Patient Representative

Datentyp

boolean

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

Exclusion Criteria

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

Patient Groups

Datentyp

boolean

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

Hepatitis B

Datentyp

boolean

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

Hepatitis B Virus Immune Tolerance

Datentyp

boolean

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

HIV coinfection | HCV coinfection

Datentyp

boolean

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

Solid organ transplant Recipient | Bone Marrow Transplant Recipient

Datentyp

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
Beschreibung

Kidney Failure | Dialysis

Datentyp

boolean

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

Hepatic decompensation

Datentyp

boolean

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

Liver carcinoma

Datentyp

boolean

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

Liver disease | Exception Hepatitis B

Datentyp

boolean

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

Chemotherapy | Immunosuppressive Agents

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Study Subject Participation Status | Research study At risk Interference

Datentyp

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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Ähnliche Modelle

Eligibility Hepatitis B, Chronic NCT02167113

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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