ID

43559

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00230477

Nyckelord

Versioner (2)
  1. 2016-09-17 2016-09-17 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00230477

Engelsk

Eligibility Hepatitis B NCT00230477

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
older than 18 years
Beskrivning

Age

Datatyp

boolean

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

Hepatitis B surface antigen positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
hbeag+
Beskrivning

Hepatitis B e antigen positive

Datatyp

boolean

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

Hepatitis B DNA Measurement

Datatyp

boolean

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

Platelet Count measurement

Datatyp

boolean

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

Hemoglobin

Datatyp

boolean

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

Alanine aminotransferase measurement

Datatyp

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))
Beskrivning

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

serum alpha-fetoprotein (AFP) measurement

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Informed Consent | Protocol Compliance

Datatyp

boolean

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

Exclusion Criteria

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

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

Datatyp

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.
Beskrivning

Hypersensitivity adefovir | Hypersensitivity Nucleoside Analogs | Hypersensitivity nucleotide analog

Datatyp

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
Beskrivning

Renal dysfunction Clinical Significance

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

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

systemic steroids

Datatyp

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
Beskrivning

Pharmaceutical Preparations Nephrotoxic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1514118
Tillbaka till toppen

Similar models

Eligibility Hepatitis B NCT00230477

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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