ID

43559

Descrição

Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT; ODM derived from: https://clinicaltrials.gov/show/NCT00230477

Link

https://clinicaltrials.gov/show/NCT00230477

Palavras-chave

Versões (2)
  1. 17/09/2016 17/09/2016 -
  2. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00230477

Inglês

Eligibility Hepatitis B NCT00230477

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
older than 18 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
hbsag+ at screening and for at least 6 months prior to study entry
Descrição

Hepatitis B surface antigen positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149709
hbeag+
Descrição

Hepatitis B e antigen positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392390
hbv dna greater than 6 log10 copies/ml
Descrição

Hepatitis B DNA Measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3641250
platelet count greater than 50,000 platelets/mm3
Descrição

Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin greater than 7.5 g/dl
Descrição

Hemoglobin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019046
alt less than uln
Descrição

Alanine aminotransferase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201836
estimated creatine clearance>50 ml/min as estimated by the crockcroft-gault equation ((140-age) x (kg)/(serum creatine x 72) (for women x 0.85))
Descrição

Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2711451
female and male participants must be practicing an effective form of contraception (male or female condom with spermicide, diaphragm or cervical cap with spermicide, intrauterine device, hormonal contraception)
Descrição

Gender Contraceptive methods | Condoms, Male | Female Condoms | Spermicide | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Intrauterine Devices | Hormonal contraception

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0009653
UMLS CUI [3]
C0221829
UMLS CUI [4]
C1144908
UMLS CUI [5]
C0042241
UMLS CUI [6]
C0493327
UMLS CUI [7]
C0021900
UMLS CUI [8]
C2985296
serum alpha-fetoprotein less than 50 ng/ml within 30 days of study entry
Descrição

serum alpha-fetoprotein (AFP) measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0546833
childs-pugh score less than 7 and no ascites, variceal bleeding, or hepatic encephalopathy
Descrição

Child-Pugh Classification | Ascites | Bleeding varices | Hepatic Encephalopathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4050412
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4]
C0019151
able to give written informed consent and to comply with the study protocol
Descrição

Informed Consent | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history or evidence of hiv, hepatitis c or hepatitis d
Descrição

HIV Evidence of | Hepatitis C Evidence of | Hepatitis D Infection Evidence of

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0332120
UMLS CUI [3,1]
C0011226
UMLS CUI [3,2]
C0332120
known or suspected hypersensitivity to adefovir or other nucleoside/nucleotide analogs.
Descrição

Hypersensitivity adefovir | Hypersensitivity Nucleoside Analogs | Hypersensitivity nucleotide analog

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0050175
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1579410
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0597107
history of clinically significant renal dysfunction
Descrição

Renal dysfunction Clinical Significance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C2826293
any active medical or psychiatric illness that, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol
Descrição

Illness Interferes with Therapeutic procedure | Mental disorder Interferes with Therapeutic procedure | Illness Interferes with Protocol Compliance | Mental disorder Interferes with Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
pregnancy or breastfeeding
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
receipt of systemic corticosteroids within 90 days of study entry
Descrição

systemic steroids

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2825233
receipt of nephrotoxic drugs within 8 weeks prior to study screening or expected use of these agents during the course of the study
Descrição

Pharmaceutical Preparations Nephrotoxic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1514118
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Similar models

Eligibility Hepatitis B NCT00230477

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
older than 18 years
boolean
C0001779 (UMLS CUI [1])
Hepatitis B surface antigen positive
Item
hbsag+ at screening and for at least 6 months prior to study entry
boolean
C0149709 (UMLS CUI [1])
Hepatitis B e antigen positive
Item
hbeag+
boolean
C0392390 (UMLS CUI [1])
Hepatitis B DNA Measurement
Item
hbv dna greater than 6 log10 copies/ml
boolean
C3641250 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count greater than 50,000 platelets/mm3
boolean
C0032181 (UMLS CUI [1])
Hemoglobin
Item
hemoglobin greater than 7.5 g/dl
boolean
C0019046 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alt less than uln
boolean
C0201836 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
estimated creatine clearance>50 ml/min as estimated by the crockcroft-gault equation ((140-age) x (kg)/(serum creatine x 72) (for women x 0.85))
boolean
C2711451 (UMLS CUI [1])
Gender Contraceptive methods | Condoms, Male | Female Condoms | Spermicide | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Intrauterine Devices | Hormonal contraception
Item
female and male participants must be practicing an effective form of contraception (male or female condom with spermicide, diaphragm or cervical cap with spermicide, intrauterine device, hormonal contraception)
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009653 (UMLS CUI [2])
C0221829 (UMLS CUI [3])
C1144908 (UMLS CUI [4])
C0042241 (UMLS CUI [5])
C0493327 (UMLS CUI [6])
C0021900 (UMLS CUI [7])
C2985296 (UMLS CUI [8])
serum alpha-fetoprotein (AFP) measurement
Item
serum alpha-fetoprotein less than 50 ng/ml within 30 days of study entry
boolean
C0546833 (UMLS CUI [1])
Child-Pugh Classification | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
childs-pugh score less than 7 and no ascites, variceal bleeding, or hepatic encephalopathy
boolean
C4050412 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
Informed Consent | Protocol Compliance
Item
able to give written informed consent and to comply with the study protocol
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
HIV Evidence of | Hepatitis C Evidence of | Hepatitis D Infection Evidence of
Item
history or evidence of hiv, hepatitis c or hepatitis d
boolean
C0019682 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0011226 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
Hypersensitivity adefovir | Hypersensitivity Nucleoside Analogs | Hypersensitivity nucleotide analog
Item
known or suspected hypersensitivity to adefovir or other nucleoside/nucleotide analogs.
boolean
C0020517 (UMLS CUI [1,1])
C0050175 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1579410 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0597107 (UMLS CUI [3,2])
Renal dysfunction Clinical Significance
Item
history of clinically significant renal dysfunction
boolean
C3279454 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Illness Interferes with Therapeutic procedure | Mental disorder Interferes with Therapeutic procedure | Illness Interferes with Protocol Compliance | Mental disorder Interferes with Protocol Compliance
Item
any active medical or psychiatric illness that, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
systemic steroids
Item
receipt of systemic corticosteroids within 90 days of study entry
boolean
C2825233 (UMLS CUI [1])
Pharmaceutical Preparations Nephrotoxic
Item
receipt of nephrotoxic drugs within 8 weeks prior to study screening or expected use of these agents during the course of the study
boolean
C0013227 (UMLS CUI [1,1])
C1514118 (UMLS CUI [1,2])
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