ID

16658

Description

Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT00095121

Link

https://clinicaltrials.gov/show/NCT00095121

Keywords

Versions (1)
  1. 7/30/16 7/30/16 -
Uploaded on

July 30, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT00095121

English

Eligibility Chronic Hepatitis B NCT00095121

1 forms  
Criteria
Description

Criteria

positive hbsag >= 6 months prior to randomization and positive hbeag at screening.
Description

Hepatitis B surface antigen positive | Hepatitis B e antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0392390
serum hbv dna greater than or equal to 1 x 100,000 copies/ml (pcr assay) at initial or confirmatory screening visit.
Description

Hepatitis B DNA Measurement | Polymerase Chain Reaction

Data type

boolean

Alias
UMLS CUI [1]
C3641250
UMLS CUI [2]
C0032520
serum alt levels greater than or equal to 1.5 x uln at both initial and confirmatory screening visits.
Description

Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
compensated liver disease with anticipated survival greater than 12 months and with the following laboratory and clinical parameters within 4 weeks of baseline:
Description

Compensated liver disease | Continuance of life Anticipated

Data type

boolean

Alias
UMLS CUI [1]
C3839044
UMLS CUI [2,1]
C0038952
UMLS CUI [2,2]
C3840775
*prothrombin time less than or equal to 1 second above normal range. *total bilirubin less than 1.3 mg/dl or normal direct bilirubin. *serum albumin greater than 3 g/dl (greater than 30 g/l). *no clinical history of ascites, variceal bleeding, encephalopathy or splenomegaly. *adequate renal function defined as creatinine clearance greater than or equal to 80 ml/min (calculated using schwartz formula).
Description

Prothrombin time assay | Bilirubin, total measurement | Bilirubin, direct measurement Normal | Serum albumin measurement | Ascites | Bleeding varices | Encephalopathies | Splenomegaly | Renal function | Creatinine clearance measurement Creatinine-based formula (Schwartz)

Data type

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0201913
UMLS CUI [3,1]
C0201916
UMLS CUI [3,2]
C0205307
UMLS CUI [4]
C0523465
UMLS CUI [5]
C0003962
UMLS CUI [6]
C0333106
UMLS CUI [7]
C0085584
UMLS CUI [8]
C0038002
UMLS CUI [9]
C0232804
UMLS CUI [10,1]
C0373595
UMLS CUI [10,2]
C1980037
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
received immunoglobulin, interferon or lamivudine therapy within 6 months prior to initial screening visit.
Description

Immunoglobulins | Interferons | Lamivudine

Data type

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0021747
UMLS CUI [3]
C0209738
participated in any investigational trial with any investigational compound within 2 months prior to initial screening.
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
organ or bone marrow transplant recipients.
Description

Transplanted organ Recipient | Autologous bone marrow transplant Recipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0524930
UMLS CUI [1,2]
C1709854
UMLS CUI [2,1]
C0194037
UMLS CUI [2,2]
C1709854
clinical evidence of decompensated liver disease.
Description

Decompensated liver disease Evidence Clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C0205210
a child-pugh-turcotte score greater than 6.
Description

Child-Pugh-Turcotte score

Data type

boolean

Alias
UMLS CUI [1]
C3854424
inability to comply with study requirements.
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Chronic Hepatitis B NCT00095121

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Hepatitis B surface antigen positive | Hepatitis B e antigen positive
Item
positive hbsag >= 6 months prior to randomization and positive hbeag at screening.
boolean
C0149709 (UMLS CUI [1])
C0392390 (UMLS CUI [2])
Hepatitis B DNA Measurement | Polymerase Chain Reaction
Item
serum hbv dna greater than or equal to 1 x 100,000 copies/ml (pcr assay) at initial or confirmatory screening visit.
boolean
C3641250 (UMLS CUI [1])
C0032520 (UMLS CUI [2])
Alanine aminotransferase measurement
Item
serum alt levels greater than or equal to 1.5 x uln at both initial and confirmatory screening visits.
boolean
C0201836 (UMLS CUI [1])
Compensated liver disease | Continuance of life Anticipated
Item
compensated liver disease with anticipated survival greater than 12 months and with the following laboratory and clinical parameters within 4 weeks of baseline:
boolean
C3839044 (UMLS CUI [1])
C0038952 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
Prothrombin time assay | Bilirubin, total measurement | Bilirubin, direct measurement Normal | Serum albumin measurement | Ascites | Bleeding varices | Encephalopathies | Splenomegaly | Renal function | Creatinine clearance measurement Creatinine-based formula (Schwartz)
Item
*prothrombin time less than or equal to 1 second above normal range. *total bilirubin less than 1.3 mg/dl or normal direct bilirubin. *serum albumin greater than 3 g/dl (greater than 30 g/l). *no clinical history of ascites, variceal bleeding, encephalopathy or splenomegaly. *adequate renal function defined as creatinine clearance greater than or equal to 80 ml/min (calculated using schwartz formula).
boolean
C0033707 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0201916 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
C0523465 (UMLS CUI [4])
C0003962 (UMLS CUI [5])
C0333106 (UMLS CUI [6])
C0085584 (UMLS CUI [7])
C0038002 (UMLS CUI [8])
C0232804 (UMLS CUI [9])
C0373595 (UMLS CUI [10,1])
C1980037 (UMLS CUI [10,2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Immunoglobulins | Interferons | Lamivudine
Item
received immunoglobulin, interferon or lamivudine therapy within 6 months prior to initial screening visit.
boolean
C0021027 (UMLS CUI [1])
C0021747 (UMLS CUI [2])
C0209738 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs
Item
participated in any investigational trial with any investigational compound within 2 months prior to initial screening.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Transplanted organ Recipient | Autologous bone marrow transplant Recipient
Item
organ or bone marrow transplant recipients.
boolean
C0524930 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C0194037 (UMLS CUI [2,1])
C1709854 (UMLS CUI [2,2])
Decompensated liver disease Evidence Clinical
Item
clinical evidence of decompensated liver disease.
boolean
C4075847 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Child-Pugh-Turcotte score
Item
a child-pugh-turcotte score greater than 6.
boolean
C3854424 (UMLS CUI [1])
Protocol Compliance Unable
Item
inability to comply with study requirements.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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