ID

22792

Description

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

Keywords

Versions (1)
  1. 6/12/17 6/12/17 -
Uploaded on

June 12, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT00606099

English

Eligibility Chronic Hepatitis B NCT00606099

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

ID.1

Data type

boolean

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

ID.2

Data type

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).
Description

ID.3

Data type

boolean

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

ID.4

Data type

boolean

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

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

ID.6

Data type

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).
Description

ID.7

Data type

boolean

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

ID.8

Data type

boolean

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

ID.9

Data type

boolean

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

ID.10

Data type

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.
Description

ID.11

Data type

boolean

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

ID.12

Data type

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.
Description

ID.13

Data type

boolean

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

ID.14

Data type

boolean

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

Eligibility Chronic Hepatitis B NCT00606099

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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