ID

20908

Description

Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT00412529

Link

https://clinicaltrials.gov/show/NCT00412529

Keywords

Versions (1)
  1. 3/27/17 3/27/17 -
Uploaded on

March 27, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00412529

English

Eligibility Hepatitis B NCT00412529

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, 18-70 years of age with documented compensated hepatitis b "e" antigen (hbeag)-positive chronic hepatitis b
Description

Age | Chronic Hepatitis B HBeAg positive Compensated

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0524909
UMLS CUI [2,2]
C0392390
UMLS CUI [2,3]
C0205432
able to comply with study regimen and provide written informed consent
Description

Protocol Compliance | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
unwilling to use double barrier method of contraception
Description

Barrier Contraception Double Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0004764
UMLS CUI [1,2]
C0205173
UMLS CUI [1,3]
C0558080
co-infected with hepatitis c virus (hcv), hepatitis d virus (hdv) or human immunodeficiency virus (hiv)
Description

HCV coinfection | HDV Coinfection | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2,1]
C0011220
UMLS CUI [2,2]
C0275524
UMLS CUI [3]
C4062778
received hepatitis b therapy in the past
Description

Therapeutic procedure Hepatitis B

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0019163
use of immunomodulatory therapy in past 12 months
Description

Immunomodulators

Data type

boolean

Alias
UMLS CUI [1]
C1527392
history of or symptoms of hepatic decompensation or pancreatitis
Description

Hepatic decompensation Symptoms | Pancreatitis Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C1394798
UMLS CUI [1,2]
C1457887
UMLS CUI [2,1]
C0030305
UMLS CUI [2,2]
C1457887
frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs
Description

Hepatotoxicity Pharmaceutical Preparations Frequent | Hepatotoxicity Pharmaceutical Preparations Prolonged | Pharmaceutical Preparations Nephrotoxic Frequent | Pharmaceutical Preparations Nephrotoxic Prolonged

Data type

boolean

Alias
UMLS CUI [1,1]
C0235378
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332183
UMLS CUI [2,1]
C0235378
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439590
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1514118
UMLS CUI [3,3]
C0332183
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C1514118
UMLS CUI [4,3]
C0439590
concurrent medication likely to preclude compliance with schedule of evaluations
Description

Pharmaceutical Preparation Excludes Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
use of other investigational drugs within 30 days of enrollment
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
abnormal laboratory values during screening
Description

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
other protocol-defined inclusion/exclusion criteria may apply
Description

Clinical Trial Eligibility Criteria Study Protocol

Data type

boolean

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

Eligibility Hepatitis B NCT00412529

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Chronic Hepatitis B HBeAg positive Compensated
Item
male or female, 18-70 years of age with documented compensated hepatitis b "e" antigen (hbeag)-positive chronic hepatitis b
boolean
C0001779 (UMLS CUI [1])
C0524909 (UMLS CUI [2,1])
C0392390 (UMLS CUI [2,2])
C0205432 (UMLS CUI [2,3])
Protocol Compliance | Informed Consent
Item
able to comply with study regimen and provide written informed consent
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Barrier Contraception Double Unwilling
Item
unwilling to use double barrier method of contraception
boolean
C0004764 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
HCV coinfection | HDV Coinfection | HIV coinfection
Item
co-infected with hepatitis c virus (hcv), hepatitis d virus (hdv) or human immunodeficiency virus (hiv)
boolean
C1698259 (UMLS CUI [1])
C0011220 (UMLS CUI [2,1])
C0275524 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Therapeutic procedure Hepatitis B
Item
received hepatitis b therapy in the past
boolean
C0087111 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
Immunomodulators
Item
use of immunomodulatory therapy in past 12 months
boolean
C1527392 (UMLS CUI [1])
Hepatic decompensation Symptoms | Pancreatitis Symptoms
Item
history of or symptoms of hepatic decompensation or pancreatitis
boolean
C1394798 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0030305 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
Hepatotoxicity Pharmaceutical Preparations Frequent | Hepatotoxicity Pharmaceutical Preparations Prolonged | Pharmaceutical Preparations Nephrotoxic Frequent | Pharmaceutical Preparations Nephrotoxic Prolonged
Item
frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs
boolean
C0235378 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332183 (UMLS CUI [1,3])
C0235378 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439590 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C1514118 (UMLS CUI [3,2])
C0332183 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C1514118 (UMLS CUI [4,2])
C0439590 (UMLS CUI [4,3])
Pharmaceutical Preparation Excludes Protocol Compliance
Item
concurrent medication likely to preclude compliance with schedule of evaluations
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Investigational New Drugs
Item
use of other investigational drugs within 30 days of enrollment
boolean
C0013230 (UMLS CUI [1])
Laboratory test result abnormal
Item
abnormal laboratory values during screening
boolean
C0438215 (UMLS CUI [1])
Clinical Trial 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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