ID

27853

Descrição

Study of Telbivudine in Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT00970216

Link

https://clinicaltrials.gov/show/NCT00970216

Palavras-chave

Versões (1)
  1. 01/12/2017 01/12/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

1 de dezembro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT00970216

Inglês

Eligibility Chronic Hepatitis B NCT00970216

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female, at least 18 years of age.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
2. documented chronic hepatitis b defined by all of the following:
Descrição

Hepatitis B, Chronic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0524909
clinical history compatible with chronic hepatitis b.
Descrição

Medical History Consistent with Chronic Hepatitis B

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524909
detectable serum hepatitis b surface antigen >= 6 months at screening visit, with either hbeag positive or negative.
Descrição

Hepatitis B Surface Antigens Detectable | Hepatitis B e antigen positive | Hepatitis B e antigen negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C3830527
UMLS CUI [2]
C0392390
UMLS CUI [3]
C0948827
3. willing and able to comply with the observational drug regimen and all other study requirements.
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
4. willing and able to provide written informed consent to participate in the study.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. females who are pregnant,intending to become pregnant or breast feeding.
Descrição

Pregnancy | Pregnancy, Planned | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
2. patients with co-infection with hepatitis c virus, hepatitis d virus or human immunodeficiency virus.
Descrição

HCV coinfection | HDV Coinfection | HIV coinfection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2,1]
C0011220
UMLS CUI [2,2]
C0275524
UMLS CUI [3]
C4062778
3. patients with hypersensitivity to telbivudine or to any of the excipients.
Descrição

Hypersensitivity telbivudine | Hypersensitivity Telbivudine Excipient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1453933
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1453933
UMLS CUI [2,3]
C0015237
4. one or more known primary or secondary causes of liver disease other than hepatitis b (e.g., alcoholism, steatohepatitis, autoimmune hepatitis, hemochromatosis, alpha-1 anti-trypsin deficiency, wilson's disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease). gilbert's syndrome and dubin-johnson syndrome will not exclude patients from participation in this trial.
Descrição

Cause Primary Quantity Liver disease | Cause Secondary Quantity Liver disease | Exception Hepatitis B | Alcoholic Intoxication, Chronic | Steatohepatitis | Hepatitis, Autoimmune | Hemochromatosis | alpha 1-Antitrypsin Deficiency | Hepatolenticular Degeneration | Condition Congenital Affecting Liver | Condition Metabolic Affecting Liver | Congestive heart failure | Cor pulmonale Severe | Gilbert syndrome allowed | Dubin Johnson syndrome allowed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0023895
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0023895
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019163
UMLS CUI [4]
C0001973
UMLS CUI [5]
C2711227
UMLS CUI [6]
C0241910
UMLS CUI [7]
C0018995
UMLS CUI [8]
C0221757
UMLS CUI [9]
C0019202
UMLS CUI [10,1]
C0348080
UMLS CUI [10,2]
C1744681
UMLS CUI [10,3]
C0392760
UMLS CUI [10,4]
C0023884
UMLS CUI [11,1]
C0348080
UMLS CUI [11,2]
C0311400
UMLS CUI [11,3]
C0392760
UMLS CUI [11,4]
C0023884
UMLS CUI [12]
C0018802
UMLS CUI [13,1]
C0034072
UMLS CUI [13,2]
C0205082
UMLS CUI [14,1]
C0017551
UMLS CUI [14,2]
C0683607
UMLS CUI [15,1]
C0022350
UMLS CUI [15,2]
C0683607
5. enrolled or planning to be enrolled in another clinical trial of an investigational agent while participating in this study.
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
6. unable to receive safety and tolerability assessments.
Descrição

Safety Assessment Receive Unable | Tolerability Study Receive Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0549076
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C3274448
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C1299582
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Similar models

Eligibility Chronic Hepatitis B NCT00970216

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female, at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Hepatitis B, Chronic
Item
2. documented chronic hepatitis b defined by all of the following:
boolean
C0524909 (UMLS CUI [1])
Medical History Consistent with Chronic Hepatitis B
Item
clinical history compatible with chronic hepatitis b.
boolean
C0262926 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524909 (UMLS CUI [1,3])
Hepatitis B Surface Antigens Detectable | Hepatitis B e antigen positive | Hepatitis B e antigen negative
Item
detectable serum hepatitis b surface antigen >= 6 months at screening visit, with either hbeag positive or negative.
boolean
C0019168 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0392390 (UMLS CUI [2])
C0948827 (UMLS CUI [3])
Protocol Compliance
Item
3. willing and able to comply with the observational drug regimen and all other study requirements.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
4. willing and able to provide written informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
1. females who are pregnant,intending to become pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
HCV coinfection | HDV Coinfection | HIV coinfection
Item
2. patients with co-infection with hepatitis c virus, hepatitis d virus or human immunodeficiency virus.
boolean
C1698259 (UMLS CUI [1])
C0011220 (UMLS CUI [2,1])
C0275524 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Hypersensitivity telbivudine | Hypersensitivity Telbivudine Excipient
Item
3. patients with hypersensitivity to telbivudine or to any of the excipients.
boolean
C0020517 (UMLS CUI [1,1])
C1453933 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1453933 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Cause Primary Quantity Liver disease | Cause Secondary Quantity Liver disease | Exception Hepatitis B | Alcoholic Intoxication, Chronic | Steatohepatitis | Hepatitis, Autoimmune | Hemochromatosis | alpha 1-Antitrypsin Deficiency | Hepatolenticular Degeneration | Condition Congenital Affecting Liver | Condition Metabolic Affecting Liver | Congestive heart failure | Cor pulmonale Severe | Gilbert syndrome allowed | Dubin Johnson syndrome allowed
Item
4. one or more known primary or secondary causes of liver disease other than hepatitis b (e.g., alcoholism, steatohepatitis, autoimmune hepatitis, hemochromatosis, alpha-1 anti-trypsin deficiency, wilson's disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease). gilbert's syndrome and dubin-johnson syndrome will not exclude patients from participation in this trial.
boolean
C0015127 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0023895 (UMLS CUI [1,4])
C0015127 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0023895 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0019163 (UMLS CUI [3,2])
C0001973 (UMLS CUI [4])
C2711227 (UMLS CUI [5])
C0241910 (UMLS CUI [6])
C0018995 (UMLS CUI [7])
C0221757 (UMLS CUI [8])
C0019202 (UMLS CUI [9])
C0348080 (UMLS CUI [10,1])
C1744681 (UMLS CUI [10,2])
C0392760 (UMLS CUI [10,3])
C0023884 (UMLS CUI [10,4])
C0348080 (UMLS CUI [11,1])
C0311400 (UMLS CUI [11,2])
C0392760 (UMLS CUI [11,3])
C0023884 (UMLS CUI [11,4])
C0018802 (UMLS CUI [12])
C0034072 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
C0017551 (UMLS CUI [14,1])
C0683607 (UMLS CUI [14,2])
C0022350 (UMLS CUI [15,1])
C0683607 (UMLS CUI [15,2])
Study Subject Participation Status | Investigational New Drugs
Item
5. enrolled or planning to be enrolled in another clinical trial of an investigational agent while participating in this study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Safety Assessment Receive Unable | Tolerability Study Receive Unable
Item
6. unable to receive safety and tolerability assessments.
boolean
C0549076 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3274448 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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