ID

28368

Descripción

Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT00877149

Link

https://clinicaltrials.gov/show/NCT00877149

Palabras clave

Versiones (1)
  1. 8/1/18 8/1/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

8 de enero de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Compensated Chronic Hepatitis B NCT00877149

Inglés

Eligibility Compensated Chronic Hepatitis B NCT00877149

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient completed study cldt600acn04 study and will be available to immediately rollover into this study without discontinuation of study drug.
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
patient was not discontinued from the previous cldt600acn04 study.
Descripción

Absence Patient withdrawn from trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0422727
adult patients with chb (hbeag positive or hbeag negative).
Descripción

Hepatitis B, Chronic | Hepatitis B e antigen positive | Hepatitis B e antigen negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0392390
UMLS CUI [3]
C0948827
hbv dna pcr undetectable in recent 12 months.
Descripción

Hbv DNA Test PCR Negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1256114
UMLS CUI [1,2]
C0032520
UMLS CUI [1,3]
C1513916
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breastfeeding, or has plan of pregnant during study period.
Descripción

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
patient is co-infected with hepatitis c virus (hcv), hepatitis d virus (hdv), or hiv at screening visit.
Descripción

HCV coinfection | Coinfection Hepatitis Delta Virus | HIV coinfection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0011220
UMLS CUI [3]
C4062778
patient has received within the past 12 months any anti-hbv treatment combination (add-on therapy) or switch to other anti hbv treatment from telbivudine at investigator's discretion.
Descripción

Combined Modality Therapy Anti-hepatitis B (HBV) Agents | telbivudine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C4020577
UMLS CUI [2]
C1453933
other protocol-defined inclusion/exclusion criteria may apply.
Descripción

Eligibility Criteria Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Compensated Chronic Hepatitis B NCT00877149

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status | Investigational New Drugs
Item
patient completed study cldt600acn04 study and will be available to immediately rollover into this study without discontinuation of study drug.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Absence Patient withdrawn from trial
Item
patient was not discontinued from the previous cldt600acn04 study.
boolean
C0332197 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
Hepatitis B, Chronic | Hepatitis B e antigen positive | Hepatitis B e antigen negative
Item
adult patients with chb (hbeag positive or hbeag negative).
boolean
C0524909 (UMLS CUI [1])
C0392390 (UMLS CUI [2])
C0948827 (UMLS CUI [3])
Hbv DNA Test PCR Negative
Item
hbv dna pcr undetectable in recent 12 months.
boolean
C1256114 (UMLS CUI [1,1])
C0032520 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant or breastfeeding, or has plan of pregnant during study period.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
HCV coinfection | Coinfection Hepatitis Delta Virus | HIV coinfection
Item
patient is co-infected with hepatitis c virus (hcv), hepatitis d virus (hdv), or hiv at screening visit.
boolean
C1698259 (UMLS CUI [1])
C0275524 (UMLS CUI [2,1])
C0011220 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Combined Modality Therapy Anti-hepatitis B (HBV) Agents | telbivudine
Item
patient has received within the past 12 months any anti-hbv treatment combination (add-on therapy) or switch to other anti hbv treatment from telbivudine at investigator's discretion.
boolean
C0009429 (UMLS CUI [1,1])
C4020577 (UMLS CUI [1,2])
C1453933 (UMLS CUI [2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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