ID

22792

Descripción

Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT00606099

Link

https://clinicaltrials.gov/show/NCT00606099

Palabras clave

Versiones (1)
  1. 12/6/17 12/6/17 -
Subido en

12 de junio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT00606099

Inglés

Eligibility Chronic Hepatitis B NCT00606099

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, at least 18 years of age.
Descripción

ID.1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
patients with compensated chronic hepatitis b who are currently receiving adefovir 10mg once daily.
Descripción

ID.2

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0050175
patients must have received adefovir 10mg once daily for at least 48 weeks continuously and have a sub-optimal response to adefovir therapy (≥4log10 copies of hbv dna/ml).
Descripción

ID.3

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0050175
UMLS CUI [1,2]
C0521982
patient is willing to comply with all study requirements.
Descripción

ID.4

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679823
patient is willing and able to provide written informed consent.
Descripción

ID.5

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing (lactating) women. all women must have a negative pregnancy test at the screening visit.
Descripción

ID.6

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0549206
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0427780
female patients of reproductive potential is unwilling to use double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide).
Descripción

ID.7

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004764
patient is co-infected with hepatitis c virus or hiv.
Descripción

ID.8

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0019196
UMLS CUI [1,3]
C0019682
patient has previously taken lamivudine.
Descripción

ID.9

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0209738
patient is currently abusing illicit drugs or alcohol.
Descripción

ID.10

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013146
UMLS CUI [1,2]
C0085762
patient is using any investigational drugs or with in the last 30 days.
Descripción

ID.11

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
patient is enrolled or plans to enroll in a clinical study involving investigational drug.
Descripción

ID.12

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
patient has a history of pancreatitis, hepatic decompsensation, hepatocellular carcinoma, or a history of hypersensitivity to telbivudine or adfovir.
Descripción

ID.13

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679831
other protocol-defined inclusion/exclusion criteria may apply.
Descripción

ID.14

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0242801
UMLS CUI [1,2]
C0205394
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Similar models

Eligibility Chronic Hepatitis B NCT00606099

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
male or female, at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
ID.2
Item
patients with compensated chronic hepatitis b who are currently receiving adefovir 10mg once daily.
boolean
C0524909 (UMLS CUI [1,1])
C0050175 (UMLS CUI [1,2])
ID.3
Item
patients must have received adefovir 10mg once daily for at least 48 weeks continuously and have a sub-optimal response to adefovir therapy (≥4log10 copies of hbv dna/ml).
boolean
C0050175 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
ID.4
Item
patient is willing to comply with all study requirements.
boolean
C0679823 (UMLS CUI [1])
ID.5
Item
patient is willing and able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.6
Item
pregnant or nursing (lactating) women. all women must have a negative pregnancy test at the screening visit.
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,3])
ID.7
Item
female patients of reproductive potential is unwilling to use double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide).
boolean
C0004764 (UMLS CUI [1])
ID.8
Item
patient is co-infected with hepatitis c virus or hiv.
boolean
C0275524 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0019682 (UMLS CUI [1,3])
ID.9
Item
patient has previously taken lamivudine.
boolean
C0209738 (UMLS CUI [1])
ID.10
Item
patient is currently abusing illicit drugs or alcohol.
boolean
C0013146 (UMLS CUI [1,1])
C0085762 (UMLS CUI [1,2])
ID.11
Item
patient is using any investigational drugs or with in the last 30 days.
boolean
C0013230 (UMLS CUI [1])
ID.12
Item
patient is enrolled or plans to enroll in a clinical study involving investigational drug.
boolean
C0013230 (UMLS CUI [1])
ID.13
Item
patient has a history of pancreatitis, hepatic decompsensation, hepatocellular carcinoma, or a history of hypersensitivity to telbivudine or adfovir.
boolean
C0679831 (UMLS CUI [1])
ID.14
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C0242801 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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