ID

23792

Description

Long-term Study With Clevudine; ODM derived from: https://clinicaltrials.gov/show/NCT00558818

Link

https://clinicaltrials.gov/show/NCT00558818

Keywords

Versions (1)
  1. 7/13/17 7/13/17 -
Uploaded on

July 13, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT00558818

English

Eligibility Chronic Hepatitis B NCT00558818

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient with dna levels >=1 x 10^5 copies/ml within 30 days of baseline.
Description

DNA Levels

Data type

boolean

Alias
UMLS CUI [1,1]
C0012854
UMLS CUI [1,2]
C0441889
patient is documented to be hbsag positive for > 6 months.
Description

Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
patient has alt levels >=80 iu/l
Description

Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
women of childbearing potential must have a negative urine (β-hcg) pregnancy test taken within 14 days of starting therapy.
Description

Childbearing Potential Urine pregnancy test Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430056
UMLS CUI [1,3]
C1513916
exclusion criteria.
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
Description

Antiviral Therapy | Immunomodulation | Cytotoxic therapy | Steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0280274
UMLS CUI [2]
C1963758
UMLS CUI [3]
C0677881
UMLS CUI [4]
C0149783
patients previously treated with interferon within the previous 6 months.
Description

Interferons

Data type

boolean

Alias
UMLS CUI [1]
C0021747
patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for hbv infection.
Description

Clevudine | Lamivudine | adefovir | entecavir | telbivudine | Nucleosides Investigational | Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0045212
UMLS CUI [2]
C0209738
UMLS CUI [3]
C0050175
UMLS CUI [4]
C0971023
UMLS CUI [5]
C1453933
UMLS CUI [6,1]
C0028621
UMLS CUI [6,2]
C1517586
UMLS CUI [7]
C0019163
patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
Description

Ascites | Bleeding varices | Hepatic Encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2]
C0333106
UMLS CUI [3]
C0019151
patient is coinfected with hcv, hdv or 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
patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
Description

Decompensated liver disease | Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C2239176
patient is pregnant or breast-feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
Description

Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
patient has a clinically relevant history of abuse of alcohol or drugs.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic(except hcc)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
Description

Immune System Diseases | Gastrointestinal Diseases | Kidney Diseases | Hematological Disease | Mental disorders | Bronchopulmonary disease | Biliary System Disorder | Cholelithiasis Asymptomatic | nervous system disorder | Heart Diseases | Malignant Neoplasms | Liver carcinoma | Hypersensitivity | Illness Interferes with Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0021053
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0004936
UMLS CUI [6]
C1096000
UMLS CUI [7]
C3275124
UMLS CUI [8,1]
C0008350
UMLS CUI [8,2]
C0231221
UMLS CUI [9]
C0027765
UMLS CUI [10]
C0018799
UMLS CUI [11]
C0006826
UMLS CUI [12]
C2239176
UMLS CUI [13]
C0020517
UMLS CUI [14,1]
C0221423
UMLS CUI [14,2]
C0521102
UMLS CUI [14,3]
C0087111
patient has creatinine clearance less than 60ml/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dl]) [note: multiply estimates by 0.85 for women]
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C2711451
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Similar models

Eligibility Chronic Hepatitis B NCT00558818

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
DNA Levels
Item
patient with dna levels >=1 x 10^5 copies/ml within 30 days of baseline.
boolean
C0012854 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
Hepatitis B surface antigen positive
Item
patient is documented to be hbsag positive for > 6 months.
boolean
C0149709 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
patient has alt levels >=80 iu/l
boolean
C0201836 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test Negative
Item
women of childbearing potential must have a negative urine (β-hcg) pregnancy test taken within 14 days of starting therapy.
boolean
C3831118 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Exclusion Criteria
Item
exclusion criteria.
boolean
C0680251 (UMLS CUI [1])
Antiviral Therapy | Immunomodulation | Cytotoxic therapy | Steroid therapy
Item
patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
boolean
C0280274 (UMLS CUI [1])
C1963758 (UMLS CUI [2])
C0677881 (UMLS CUI [3])
C0149783 (UMLS CUI [4])
Interferons
Item
patients previously treated with interferon within the previous 6 months.
boolean
C0021747 (UMLS CUI [1])
Clevudine | Lamivudine | adefovir | entecavir | telbivudine | Nucleosides Investigational | Hepatitis B
Item
patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for hbv infection.
boolean
C0045212 (UMLS CUI [1])
C0209738 (UMLS CUI [2])
C0050175 (UMLS CUI [3])
C0971023 (UMLS CUI [4])
C1453933 (UMLS CUI [5])
C0028621 (UMLS CUI [6,1])
C1517586 (UMLS CUI [6,2])
C0019163 (UMLS CUI [7])
Ascites | Bleeding varices | Hepatic Encephalopathy
Item
patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
boolean
C0003962 (UMLS CUI [1])
C0333106 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
HCV coinfection | HDV Coinfection | HIV coinfection
Item
patient is coinfected with hcv, hdv or hiv.
boolean
C1698259 (UMLS CUI [1])
C0011220 (UMLS CUI [2,1])
C0275524 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Decompensated liver disease | Liver carcinoma
Item
patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
boolean
C4075847 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
patient is pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive methods Unwilling
Item
patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Substance Use Disorders
Item
patient has a clinically relevant history of abuse of alcohol or drugs.
boolean
C0038586 (UMLS CUI [1])
Immune System Diseases | Gastrointestinal Diseases | Kidney Diseases | Hematological Disease | Mental disorders | Bronchopulmonary disease | Biliary System Disorder | Cholelithiasis Asymptomatic | nervous system disorder | Heart Diseases | Malignant Neoplasms | Liver carcinoma | Hypersensitivity | Illness Interferes with Therapeutic procedure
Item
patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic(except hcc)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
boolean
C0021053 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
C1096000 (UMLS CUI [6])
C3275124 (UMLS CUI [7])
C0008350 (UMLS CUI [8,1])
C0231221 (UMLS CUI [8,2])
C0027765 (UMLS CUI [9])
C0018799 (UMLS CUI [10])
C0006826 (UMLS CUI [11])
C2239176 (UMLS CUI [12])
C0020517 (UMLS CUI [13])
C0221423 (UMLS CUI [14,1])
C0521102 (UMLS CUI [14,2])
C0087111 (UMLS CUI [14,3])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
patient has creatinine clearance less than 60ml/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dl]) [note: multiply estimates by 0.85 for women]
boolean
C2711451 (UMLS CUI [1])
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