ID

36269

Description

Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02058108

Link

https://clinicaltrials.gov/show/NCT02058108

Keywords

Versions (1)
  1. 4/27/19 4/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT02058108

English

Eligibility Chronic Hepatitis B NCT02058108

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical history compatible with compensated chronic hepatitis b
Description

Medical History Consistent with Chronic Hepatitis B Compensated

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524909
UMLS CUI [1,4]
C0205432
documented compensated chronic hepatitis b defined by the following:
Description

Chronic Hepatitis B Compensated

Data type

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0205432
opositive serum hbsag at screening and at least one other documentation of hbsag positive at least 6 months prior to screening ofor hbeag positive patients at screening, significant biologic and/or histologic signs of disease activity following easl guidelines recommendations for chb pediatric patients (serum hbv dna level ≥ 5 log10 copies/ml (or 20 000 iu/ml) (cobas taqman®) at screening ; serum alt ≥ 1.5×uln and < 10×uln (pediatric uln) for two times during the screening period or within 6 months prior to screening ofor hbeag negative patients at screening, significant biologic and/or histologic signs of disease activity following easl guidelines recommendations for chb pediatric patients (serum hbv dna level ≥ 4 log10 copies/ml (or 2 000 iu/ml) (cobas taqman®) at screening) ; serum alt ≥ 1.0 ×uln and < 10×uln (pediatric uln) for two times during the screening period or within 12 months prior to screening)
Description

Serum Hepatitis B Surface Antigen Test Positive | Hepatitis B surface antigen positive Quantity | Hepatitis B e antigen positive | Signs Disease | Hepatitis B DNA Measurement | Alanine aminotransferase increased Quantity | Hepatitis B e antigen negative

Data type

boolean

Alias
UMLS CUI [1,1]
C1254699
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0149709
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0392390
UMLS CUI [4,1]
C0311392
UMLS CUI [4,2]
C0012634
UMLS CUI [5]
C3641250
UMLS CUI [6,1]
C0151905
UMLS CUI [6,2]
C1265611
UMLS CUI [7]
C0948827
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with acute or chronic infection of hcv, hdv, hiv, or with acute infection of hav, hev, cmv, ebv, or hsv.
Description

Hepatitis C | Hepatitis C, Chronic | Hepatitis D Infection | Hepatitis D, Chronic | HIV Infection | Chronic infection with HIV | Hepatitis A | Hepatitis E | Cytomegalovirus Infections | Epstein-Barr Virus Infections | Herpes Simplex Virus Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C0524910
UMLS CUI [3]
C0011226
UMLS CUI [4]
C0524911
UMLS CUI [5]
C0019693
UMLS CUI [6]
C0853112
UMLS CUI [7]
C0019159
UMLS CUI [8]
C0085293
UMLS CUI [9]
C0010823
UMLS CUI [10]
C0149678
UMLS CUI [11]
C0019348
patient has received treatment of interferon or any other immunomodulatory agents within the last 12 months prior to screening or any nucleoside or nucleotide drugs or other anti-chb treatment (approved or investigational) at any time before screening
Description

Interferon | Biological Response Modifiers | Nucleosides | Nucleotides | Therapeutic procedure Against Chronic Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C3652465
UMLS CUI [2]
C0005525
UMLS CUI [3]
C0028621
UMLS CUI [4]
C0028630
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0521124
UMLS CUI [5,3]
C0524909
patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir, systemic corticosteroids, potentially hepatotoxic drugs or nephrotoxic drugs or chemotherapy
Description

Patient need for Acyclovir Systemic | Patient need for Famciclovir | Patient need for CORTICOSTEROIDS SYSTEMIC | Patient need for Pharmaceutical Preparations Hepatotoxic effect | Patient need for Pharmaceutical Preparations Nephrotoxic | Patient need for Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0001367
UMLS CUI [1,3]
C0205373
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0209227
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C3653708
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C0235378
UMLS CUI [5,1]
C0686904
UMLS CUI [5,2]
C0013227
UMLS CUI [5,3]
C1514118
UMLS CUI [6,1]
C0686904
UMLS CUI [6,2]
C0392920
patient has one or more additional known primary or secondary causes of liver disease, other than chb; has a decompensated liver disease ; is a liver transplant recipient or organ or bone marrow transplant recipient.
Description

Cause Primary Quantity Liver disease | Cause Secondary Quantity Liver disease | Exception Chronic Hepatitis B | Decompensated Liver Disease | Liver transplant recipient | Organ transplant Recipient | Bone marrow transplant recipient

Data type

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]
C0524909
UMLS CUI [4]
C0745744
UMLS CUI [5]
C3811922
UMLS CUI [6,1]
C0524930
UMLS CUI [6,2]
C1709854
UMLS CUI [7]
C4545296
history of any other acute or chronic medical condition (that in the opinion of the investigator would make the patient unsuitable for inclusion into the study.
Description

Other medical condition Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1548788
patient has a history of myopathy, myositis, persistent muscle weakness or persistent high serum ck levels (≥7×uln), any muscular disease
Description

Myopathy | Myositis | Muscle Weakness Persistent | High serum creatine kinase Persistent | Muscular disease Any

Data type

boolean

Alias
UMLS CUI [1]
C0026848
UMLS CUI [2]
C0027121
UMLS CUI [3,1]
C0151786
UMLS CUI [3,2]
C0205322
UMLS CUI [4,1]
C0241005
UMLS CUI [4,2]
C0205322
UMLS CUI [5,1]
C0026848
UMLS CUI [5,2]
C1552551
patient receiving any drugs potentially associated with myopathy within 3 months prior to screening
Description

Pharmaceutical Preparations Associated with Myopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0026848
any other clinical significant disease, condition or abnormality, unrelated to their hbv infection at screening, as assessed by the investigator
Description

Disease Clinical Significance | Condition Clinical Significance | Abnormality Clinical Significance | Independent of Hepatitis B

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2826293
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C2826293
UMLS CUI [4,1]
C0332291
UMLS CUI [4,2]
C0019163
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Similar models

Eligibility Chronic Hepatitis B NCT02058108

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Medical History Consistent with Chronic Hepatitis B Compensated
Item
clinical history compatible with compensated chronic hepatitis b
boolean
C0262926 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524909 (UMLS CUI [1,3])
C0205432 (UMLS CUI [1,4])
Chronic Hepatitis B Compensated
Item
documented compensated chronic hepatitis b defined by the following:
boolean
C0524909 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
Serum Hepatitis B Surface Antigen Test Positive | Hepatitis B surface antigen positive Quantity | Hepatitis B e antigen positive | Signs Disease | Hepatitis B DNA Measurement | Alanine aminotransferase increased Quantity | Hepatitis B e antigen negative
Item
opositive serum hbsag at screening and at least one other documentation of hbsag positive at least 6 months prior to screening ofor hbeag positive patients at screening, significant biologic and/or histologic signs of disease activity following easl guidelines recommendations for chb pediatric patients (serum hbv dna level ≥ 5 log10 copies/ml (or 20 000 iu/ml) (cobas taqman®) at screening ; serum alt ≥ 1.5×uln and < 10×uln (pediatric uln) for two times during the screening period or within 6 months prior to screening ofor hbeag negative patients at screening, significant biologic and/or histologic signs of disease activity following easl guidelines recommendations for chb pediatric patients (serum hbv dna level ≥ 4 log10 copies/ml (or 2 000 iu/ml) (cobas taqman®) at screening) ; serum alt ≥ 1.0 ×uln and < 10×uln (pediatric uln) for two times during the screening period or within 12 months prior to screening)
boolean
C1254699 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0149709 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0392390 (UMLS CUI [3])
C0311392 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C3641250 (UMLS CUI [5])
C0151905 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0948827 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Hepatitis C | Hepatitis C, Chronic | Hepatitis D Infection | Hepatitis D, Chronic | HIV Infection | Chronic infection with HIV | Hepatitis A | Hepatitis E | Cytomegalovirus Infections | Epstein-Barr Virus Infections | Herpes Simplex Virus Infection
Item
patients with acute or chronic infection of hcv, hdv, hiv, or with acute infection of hav, hev, cmv, ebv, or hsv.
boolean
C0019196 (UMLS CUI [1])
C0524910 (UMLS CUI [2])
C0011226 (UMLS CUI [3])
C0524911 (UMLS CUI [4])
C0019693 (UMLS CUI [5])
C0853112 (UMLS CUI [6])
C0019159 (UMLS CUI [7])
C0085293 (UMLS CUI [8])
C0010823 (UMLS CUI [9])
C0149678 (UMLS CUI [10])
C0019348 (UMLS CUI [11])
Interferon | Biological Response Modifiers | Nucleosides | Nucleotides | Therapeutic procedure Against Chronic Hepatitis B
Item
patient has received treatment of interferon or any other immunomodulatory agents within the last 12 months prior to screening or any nucleoside or nucleotide drugs or other anti-chb treatment (approved or investigational) at any time before screening
boolean
C3652465 (UMLS CUI [1])
C0005525 (UMLS CUI [2])
C0028621 (UMLS CUI [3])
C0028630 (UMLS CUI [4])
C0087111 (UMLS CUI [5,1])
C0521124 (UMLS CUI [5,2])
C0524909 (UMLS CUI [5,3])
Patient need for Acyclovir Systemic | Patient need for Famciclovir | Patient need for CORTICOSTEROIDS SYSTEMIC | Patient need for Pharmaceutical Preparations Hepatotoxic effect | Patient need for Pharmaceutical Preparations Nephrotoxic | Patient need for Chemotherapy
Item
patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir, systemic corticosteroids, potentially hepatotoxic drugs or nephrotoxic drugs or chemotherapy
boolean
C0686904 (UMLS CUI [1,1])
C0001367 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0209227 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C3653708 (UMLS CUI [3,2])
C0686904 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0235378 (UMLS CUI [4,3])
C0686904 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C1514118 (UMLS CUI [5,3])
C0686904 (UMLS CUI [6,1])
C0392920 (UMLS CUI [6,2])
Cause Primary Quantity Liver disease | Cause Secondary Quantity Liver disease | Exception Chronic Hepatitis B | Decompensated Liver Disease | Liver transplant recipient | Organ transplant Recipient | Bone marrow transplant recipient
Item
patient has one or more additional known primary or secondary causes of liver disease, other than chb; has a decompensated liver disease ; is a liver transplant recipient or organ or bone marrow transplant recipient.
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])
C0524909 (UMLS CUI [3,2])
C0745744 (UMLS CUI [4])
C3811922 (UMLS CUI [5])
C0524930 (UMLS CUI [6,1])
C1709854 (UMLS CUI [6,2])
C4545296 (UMLS CUI [7])
Other medical condition Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status Inappropriate
Item
history of any other acute or chronic medical condition (that in the opinion of the investigator would make the patient unsuitable for inclusion into the study.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0008679 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
Myopathy | Myositis | Muscle Weakness Persistent | High serum creatine kinase Persistent | Muscular disease Any
Item
patient has a history of myopathy, myositis, persistent muscle weakness or persistent high serum ck levels (≥7×uln), any muscular disease
boolean
C0026848 (UMLS CUI [1])
C0027121 (UMLS CUI [2])
C0151786 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
C0241005 (UMLS CUI [4,1])
C0205322 (UMLS CUI [4,2])
C0026848 (UMLS CUI [5,1])
C1552551 (UMLS CUI [5,2])
Pharmaceutical Preparations Associated with Myopathy
Item
patient receiving any drugs potentially associated with myopathy within 3 months prior to screening
boolean
C0013227 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0026848 (UMLS CUI [1,3])
Disease Clinical Significance | Condition Clinical Significance | Abnormality Clinical Significance | Independent of Hepatitis B
Item
any other clinical significant disease, condition or abnormality, unrelated to their hbv infection at screening, as assessed by the investigator
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C1704258 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0332291 (UMLS CUI [4,1])
C0019163 (UMLS CUI [4,2])
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