ID

44701

Description

Suboptimal Responders to Adefovir Switching to Entecavir; ODM derived from: https://clinicaltrials.gov/show/NCT00718887

Link

https://clinicaltrials.gov/show/NCT00718887

Keywords

Versions (2)
  1. 4/11/18 4/11/18 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hepatitis B, Chronic NCT00718887

English

Eligibility Hepatitis B, Chronic NCT00718887

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic infection with hepatitis b virus (hbv)(detectable hepatitis b surface antibody (hbsag) at screening and at least 24 weeks prior to screening, or detectable hbsag for <24 weeks and negative for immunoglobulin m core antibody)
Description

Hepatitis B, Chronic | Anti-HBs antibody Detectable | Hepatitis B Surface Antigens Detectable | Antibody to hepatitis B core antigen IgM type Negative

Data type

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2,1]
C0201478
UMLS CUI [2,2]
C3830527
UMLS CUI [3,1]
C0019168
UMLS CUI [3,2]
C3830527
UMLS CUI [4,1]
C0312632
UMLS CUI [4,2]
C1513916
documentation of hepatitis b e antigen (hbeag) positive or negative status
Description

Hepatitis B e antigen positive | Hepatitis B e antigen negative

Data type

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C0948827
naive to nucleoside/nucleotide analogues, with the exception of adefovir
Description

Nucleoside Analogs naive | Nucleotide analog naive | Exception Adefovir

Data type

boolean

Alias
UMLS CUI [1,1]
C1579410
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C0597107
UMLS CUI [2,2]
C0919936
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0050175
suboptimal response to adefovir treatment
Description

Response Suboptimal Adefovir

Data type

boolean

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C2984009
UMLS CUI [1,3]
C0050175
no lamivudine/telbivudine, entecavir, or adefovir resistance-associated substitutions at screening
Description

Lamivudine Resistance Substitution Absent | Telbivudine Resistance Substitution Absent | Entecavir Resistance Substitution Absent | Adefovir Resistance Substitution Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0209738
UMLS CUI [1,2]
C1514892
UMLS CUI [1,3]
C1706204
UMLS CUI [1,4]
C0332197
UMLS CUI [2,1]
C1453933
UMLS CUI [2,2]
C1514892
UMLS CUI [2,3]
C1706204
UMLS CUI [2,4]
C0332197
UMLS CUI [3,1]
C0971023
UMLS CUI [3,2]
C1514892
UMLS CUI [3,3]
C1706204
UMLS CUI [3,4]
C0332197
UMLS CUI [4,1]
C0050175
UMLS CUI [4,2]
C1514892
UMLS CUI [4,3]
C1706204
UMLS CUI [4,4]
C0332197
male or female gender, aged 16 years and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
compensated liver function
Description

Liver function Compensated

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205432
serum alanine aminotransferase level <10*upper limit of normal at screening
Description

Serum alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C1883008
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
evidence of decompensated cirrhosis
Description

Decompensated cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C1619727
coinfection with hiv, hepatitis c virus, or hepatitis d virus
Description

HIV coinfection | HCV coinfection | HDV Coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C1698259
UMLS CUI [3,1]
C0011220
UMLS CUI [3,2]
C0275524
recent history of pancreatitis (within 24 weeks prior to the first dose of study medication)
Description

Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305
chronic renal insufficiency, defined as a creatinine clearance <50 ml/min
Description

Chronic Kidney Insufficiency | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0403447
UMLS CUI [2]
C0373595
current abuse of illegal drugs or alcohol, sufficient in the investigator's opinion to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis
Description

DRUG ABUSE ILLICIT Preventing Protocol Compliance | Alcohol abuse Preventing Protocol Compliance | DRUG ABUSE ILLICIT At risk Hepatotoxicity | Alcohol abuse At risk Hepatotoxicity | DRUG ABUSE ILLICIT At risk Pancreatitis | Alcohol abuse At risk Pancreatitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0743253
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0085762
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0743253
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0235378
UMLS CUI [4,1]
C0085762
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0235378
UMLS CUI [5,1]
C0743253
UMLS CUI [5,2]
C1444641
UMLS CUI [5,3]
C0030305
UMLS CUI [6,1]
C0085762
UMLS CUI [6,2]
C1444641
UMLS CUI [6,3]
C0030305
other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications
Description

Medical condition Excludes Completion of clinical trial | Medical condition Requirement Illicit medication use chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0281875
UMLS CUI [2,4]
C0205191
serum creatinine level >1.5 mg/dl; hemoglobin level <10.0 g/dl; platelet count <70,000/mm^3; absolute neutrophil count <1500 cells/mm^3; serum alpha fetoprotein level >100 ng/ml
Description

Creatinine measurement, serum | Hemoglobin measurement | Platelet Count measurement | Absolute neutrophil count | Alpha-1-fetoprotein measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0373538
except adefovir, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis b (eg, lamivudine, entecavir), or any other experimental anti-hbv antiviral, or any china traditional medicine
Description

Exception Adefovir | Nucleoside Analogs Previous Against Hepatitis B | Nucleotide analog Previous Against Hepatitis B | Lamivudine | Entecavir | Anti-HBV Antivirals | TCM Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0050175
UMLS CUI [2,1]
C1579410
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0521124
UMLS CUI [2,4]
C0019163
UMLS CUI [3,1]
C0597107
UMLS CUI [3,2]
C0205156
UMLS CUI [3,3]
C0521124
UMLS CUI [3,4]
C0019163
UMLS CUI [4]
C0209738
UMLS CUI [5]
C0971023
UMLS CUI [6,1]
C4020577
UMLS CUI [6,2]
C0003451
UMLS CUI [7,1]
C0025124
UMLS CUI [7,2]
C0013227
therapy with interferon, thymosin alpha, or other immunostimulators within 24 weeks of randomization
Description

Interferon | alpha-Thymosin | Immunostimulants

Data type

boolean

Alias
UMLS CUI [1]
C3652465
UMLS CUI [2]
C0368651
UMLS CUI [3]
C0001551
required chronic administration of medications that cause immunosuppression, that are associated with a high risk of nephrotoxicity or hepatotoxicity, or that affect renal excretion.
Description

Requirement Immunosuppressive Agents chronic | High risk of Nephrotoxicity | High risk of Hepatotoxicity | Immunosuppressive Agents chronic Affecting Renal Elimination

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0021081
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0599918
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0235378
UMLS CUI [4,1]
C0021081
UMLS CUI [4,2]
C0205191
UMLS CUI [4,3]
C0392760
UMLS CUI [4,4]
C1373187
Back to the top of the page

Similar models

Eligibility Hepatitis B, Chronic NCT00718887

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B, Chronic | Anti-HBs antibody Detectable | Hepatitis B Surface Antigens Detectable | Antibody to hepatitis B core antigen IgM type Negative
Item
chronic infection with hepatitis b virus (hbv)(detectable hepatitis b surface antibody (hbsag) at screening and at least 24 weeks prior to screening, or detectable hbsag for <24 weeks and negative for immunoglobulin m core antibody)
boolean
C0524909 (UMLS CUI [1])
C0201478 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
C0019168 (UMLS CUI [3,1])
C3830527 (UMLS CUI [3,2])
C0312632 (UMLS CUI [4,1])
C1513916 (UMLS CUI [4,2])
Hepatitis B e antigen positive | Hepatitis B e antigen negative
Item
documentation of hepatitis b e antigen (hbeag) positive or negative status
boolean
C0392390 (UMLS CUI [1])
C0948827 (UMLS CUI [2])
Nucleoside Analogs naive | Nucleotide analog naive | Exception Adefovir
Item
naive to nucleoside/nucleotide analogues, with the exception of adefovir
boolean
C1579410 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0597107 (UMLS CUI [2,1])
C0919936 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0050175 (UMLS CUI [3,2])
Response Suboptimal Adefovir
Item
suboptimal response to adefovir treatment
boolean
C1704632 (UMLS CUI [1,1])
C2984009 (UMLS CUI [1,2])
C0050175 (UMLS CUI [1,3])
Lamivudine Resistance Substitution Absent | Telbivudine Resistance Substitution Absent | Entecavir Resistance Substitution Absent | Adefovir Resistance Substitution Absent
Item
no lamivudine/telbivudine, entecavir, or adefovir resistance-associated substitutions at screening
boolean
C0209738 (UMLS CUI [1,1])
C1514892 (UMLS CUI [1,2])
C1706204 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C1453933 (UMLS CUI [2,1])
C1514892 (UMLS CUI [2,2])
C1706204 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C0971023 (UMLS CUI [3,1])
C1514892 (UMLS CUI [3,2])
C1706204 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
C0050175 (UMLS CUI [4,1])
C1514892 (UMLS CUI [4,2])
C1706204 (UMLS CUI [4,3])
C0332197 (UMLS CUI [4,4])
Age
Item
male or female gender, aged 16 years and older
boolean
C0001779 (UMLS CUI [1])
Liver function Compensated
Item
compensated liver function
boolean
C0232741 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
Serum alanine aminotransferase measurement
Item
serum alanine aminotransferase level <10*upper limit of normal at screening
boolean
C1883008 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Decompensated cirrhosis
Item
evidence of decompensated cirrhosis
boolean
C1619727 (UMLS CUI [1])
HIV coinfection | HCV coinfection | HDV Coinfection
Item
coinfection with hiv, hepatitis c virus, or hepatitis d virus
boolean
C4062778 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
C0011220 (UMLS CUI [3,1])
C0275524 (UMLS CUI [3,2])
Pancreatitis
Item
recent history of pancreatitis (within 24 weeks prior to the first dose of study medication)
boolean
C0030305 (UMLS CUI [1])
Chronic Kidney Insufficiency | Creatinine clearance measurement
Item
chronic renal insufficiency, defined as a creatinine clearance <50 ml/min
boolean
C0403447 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
DRUG ABUSE ILLICIT Preventing Protocol Compliance | Alcohol abuse Preventing Protocol Compliance | DRUG ABUSE ILLICIT At risk Hepatotoxicity | Alcohol abuse At risk Hepatotoxicity | DRUG ABUSE ILLICIT At risk Pancreatitis | Alcohol abuse At risk Pancreatitis
Item
current abuse of illegal drugs or alcohol, sufficient in the investigator's opinion to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis
boolean
C0743253 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0085762 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0743253 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0235378 (UMLS CUI [3,3])
C0085762 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0235378 (UMLS CUI [4,3])
C0743253 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C0030305 (UMLS CUI [5,3])
C0085762 (UMLS CUI [6,1])
C1444641 (UMLS CUI [6,2])
C0030305 (UMLS CUI [6,3])
Medical condition Excludes Completion of clinical trial | Medical condition Requirement Illicit medication use chronic
Item
other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0281875 (UMLS CUI [2,3])
C0205191 (UMLS CUI [2,4])
Creatinine measurement, serum | Hemoglobin measurement | Platelet Count measurement | Absolute neutrophil count | Alpha-1-fetoprotein measurement, serum
Item
serum creatinine level >1.5 mg/dl; hemoglobin level <10.0 g/dl; platelet count <70,000/mm^3; absolute neutrophil count <1500 cells/mm^3; serum alpha fetoprotein level >100 ng/ml
boolean
C0201976 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0373538 (UMLS CUI [5])
Exception Adefovir | Nucleoside Analogs Previous Against Hepatitis B | Nucleotide analog Previous Against Hepatitis B | Lamivudine | Entecavir | Anti-HBV Antivirals | TCM Preparations
Item
except adefovir, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis b (eg, lamivudine, entecavir), or any other experimental anti-hbv antiviral, or any china traditional medicine
boolean
C1705847 (UMLS CUI [1,1])
C0050175 (UMLS CUI [1,2])
C1579410 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0521124 (UMLS CUI [2,3])
C0019163 (UMLS CUI [2,4])
C0597107 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0521124 (UMLS CUI [3,3])
C0019163 (UMLS CUI [3,4])
C0209738 (UMLS CUI [4])
C0971023 (UMLS CUI [5])
C4020577 (UMLS CUI [6,1])
C0003451 (UMLS CUI [6,2])
C0025124 (UMLS CUI [7,1])
C0013227 (UMLS CUI [7,2])
Interferon | alpha-Thymosin | Immunostimulants
Item
therapy with interferon, thymosin alpha, or other immunostimulators within 24 weeks of randomization
boolean
C3652465 (UMLS CUI [1])
C0368651 (UMLS CUI [2])
C0001551 (UMLS CUI [3])
Requirement Immunosuppressive Agents chronic | High risk of Nephrotoxicity | High risk of Hepatotoxicity | Immunosuppressive Agents chronic Affecting Renal Elimination
Item
required chronic administration of medications that cause immunosuppression, that are associated with a high risk of nephrotoxicity or hepatotoxicity, or that affect renal excretion.
boolean
C1514873 (UMLS CUI [1,1])
C0021081 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0332167 (UMLS CUI [2,1])
C0599918 (UMLS CUI [2,2])
C0332167 (UMLS CUI [3,1])
C0235378 (UMLS CUI [3,2])
C0021081 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C1373187 (UMLS CUI [4,4])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial