ID

29683

Beskrivning

Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus; ODM derived from: https://clinicaltrials.gov/show/NCT00410202

Länk

https://clinicaltrials.gov/show/NCT00410202

Nyckelord

Versioner (1)
  1. 2018-04-11 2018-04-11 -
Rättsinnehavare

See clinicaltrials.gov

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11 april 2018

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT00410202

Engelsk

Eligibility Hepatitis B, Chronic NCT00410202

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
evidence of lamivudine (lvd) resistance
Beskrivning

Lamivudine Resistance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0209738
UMLS CUI [1,2]
C1514892
subjects must have a history of previous lvd treatment at screening, and must have evidence of at least 1 lvd resistance substitution (valine, isoleucine, or serine) at reverse transcriptase codon 204 (m204v/i/s)
Beskrivning

Lamivudine | Lamivudine Resistance Substitution Quantity | Valine | Isoleucine | Serine | Reverse transcriptase Codon 204 | M204V | M204I | M204S

Datatyp

boolean

Alias
UMLS CUI [1]
C0209738
UMLS CUI [2,1]
C0209738
UMLS CUI [2,2]
C1514892
UMLS CUI [2,3]
C1706204
UMLS CUI [2,4]
C1265611
UMLS CUI [3]
C0042285
UMLS CUI [4]
C0022192
UMLS CUI [5]
C0036720
UMLS CUI [6,1]
C0035379
UMLS CUI [6,2]
C1977747
UMLS CUI [7]
C2963593
UMLS CUI [8]
C2963591
UMLS CUI [9]
C2963592
nucleoside- and nucleotide-naive, except for lvd, and had chronic hepatitis b (hbv) infection
Beskrivning

Nucleosides naive | Nucleotides naive | Exception Lamivudine | Hepatitis B, Chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0028621
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C0028630
UMLS CUI [2,2]
C0919936
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0209738
UMLS CUI [4]
C0524909
compensated liver function and must have met all of the following criteria:international normalization ratio (inr) ≤ 1.5; serum albumin ≥ 3 g/dl (≥ 30 g/l); serum total bilirubin ≤ 2.5 mg/dl (≤ 42.75 μmol/l)
Beskrivning

Liver function Compensated | International Normalized Ratio | Serum albumin measurement | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205432
UMLS CUI [2]
C0525032
UMLS CUI [3]
C0523465
UMLS CUI [4]
C1278039
hbv dna > 1.72 x 10*4* iu/ml (approximately 10*5* copies/ml)
Beskrivning

Hepatitis B DNA Measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C3641250
documentation of hepatitis b e antigen (hbeag) positive and hepatitis b e antibody (hbeab) negative status at screening
Beskrivning

Hepatitis B e antigen positive | Hepatitis B e antigen negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C0948827
alanine aminotransferase (alt) ≤ 10 * upper limit of normal (uln) at screening
Beskrivning

Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study (and for up to 6 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
wocbp include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal. post menopausal is defined as:
Beskrivning

Menarche | Female Sterilization Absent | Hysterectomy Absent | Bilateral tubal ligation Absent | Bilateral oophorectomy Absent | Postmenopausal state Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0025274
UMLS CUI [2,1]
C0015787
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0020699
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0589114
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0278321
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0232970
UMLS CUI [6,2]
C0332197
women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential
Beskrivning

Contraceptives, Oral | Hormonal contraception | Vaginal contraception | Transdermal contraception | Contraceptive implant | Injectable contraception | Intrauterine Devices | Contraception, Barrier | Vaginal contraceptive diaphragm | Female Condoms | Vaginal Spermicides | Sexual Abstinence | Partner Infertility | Partner had vasectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0009905
UMLS CUI [2]
C2985296
UMLS CUI [3]
C0234007
UMLS CUI [4]
C1168146
UMLS CUI [5]
C1657106
UMLS CUI [6]
C1262153
UMLS CUI [7]
C0021900
UMLS CUI [8]
C0004764
UMLS CUI [9]
C0042241
UMLS CUI [10]
C0221829
UMLS CUI [11]
C0087145
UMLS CUI [12]
C0036899
UMLS CUI [13,1]
C0682323
UMLS CUI [13,2]
C0021359
UMLS CUI [14]
C0420842
wocbp must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of human chorionic gonadotropin) within 72 hours prior to the start of investigational product
Beskrivning

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Human chorionic gonadotropin measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
UMLS CUI [3]
C0428402
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of decompensated cirrhosis
Beskrivning

Decompensated cirrhosis

Datatyp

boolean

Alias
UMLS CUI [1]
C1619727
coinfection with human immunodeficiency virus, hepatitis c virus , or hepatitis d virus
Beskrivning

HIV coinfection | HCV coinfection | HDV Coinfection

Datatyp

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C1698259
UMLS CUI [3,1]
C0011220
UMLS CUI [3,2]
C0275524
women who are pregnant or breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
sexually active fertile men not using effective birth control if their partners were wocbp
Beskrivning

Gender Fertile | Sexually active Contraceptive methods Absent | Partner Childbearing Potential

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0015895
UMLS CUI [2,1]
C0241028
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0682323
UMLS CUI [3,2]
C3831118
laboratory values out of protocol-specified range
Beskrivning

Laboratory test result abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
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Similar models

Eligibility Hepatitis B, Chronic NCT00410202

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Lamivudine Resistance
Item
evidence of lamivudine (lvd) resistance
boolean
C0209738 (UMLS CUI [1,1])
C1514892 (UMLS CUI [1,2])
Lamivudine | Lamivudine Resistance Substitution Quantity | Valine | Isoleucine | Serine | Reverse transcriptase Codon 204 | M204V | M204I | M204S
Item
subjects must have a history of previous lvd treatment at screening, and must have evidence of at least 1 lvd resistance substitution (valine, isoleucine, or serine) at reverse transcriptase codon 204 (m204v/i/s)
boolean
C0209738 (UMLS CUI [1])
C0209738 (UMLS CUI [2,1])
C1514892 (UMLS CUI [2,2])
C1706204 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0042285 (UMLS CUI [3])
C0022192 (UMLS CUI [4])
C0036720 (UMLS CUI [5])
C0035379 (UMLS CUI [6,1])
C1977747 (UMLS CUI [6,2])
C2963593 (UMLS CUI [7])
C2963591 (UMLS CUI [8])
C2963592 (UMLS CUI [9])
Nucleosides naive | Nucleotides naive | Exception Lamivudine | Hepatitis B, Chronic
Item
nucleoside- and nucleotide-naive, except for lvd, and had chronic hepatitis b (hbv) infection
boolean
C0028621 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0028630 (UMLS CUI [2,1])
C0919936 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0209738 (UMLS CUI [3,2])
C0524909 (UMLS CUI [4])
Liver function Compensated | International Normalized Ratio | Serum albumin measurement | Serum total bilirubin measurement
Item
compensated liver function and must have met all of the following criteria:international normalization ratio (inr) ≤ 1.5; serum albumin ≥ 3 g/dl (≥ 30 g/l); serum total bilirubin ≤ 2.5 mg/dl (≤ 42.75 μmol/l)
boolean
C0232741 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
C0525032 (UMLS CUI [2])
C0523465 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
Hepatitis B DNA Measurement
Item
hbv dna > 1.72 x 10*4* iu/ml (approximately 10*5* copies/ml)
boolean
C3641250 (UMLS CUI [1])
Hepatitis B e antigen positive | Hepatitis B e antigen negative
Item
documentation of hepatitis b e antigen (hbeag) positive and hepatitis b e antibody (hbeab) negative status at screening
boolean
C0392390 (UMLS CUI [1])
C0948827 (UMLS CUI [2])
Alanine aminotransferase increased
Item
alanine aminotransferase (alt) ≤ 10 * upper limit of normal (uln) at screening
boolean
C0151905 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study (and for up to 6 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Menarche | Female Sterilization Absent | Hysterectomy Absent | Bilateral tubal ligation Absent | Bilateral oophorectomy Absent | Postmenopausal state Absent
Item
wocbp include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal. post menopausal is defined as:
boolean
C0025274 (UMLS CUI [1])
C0015787 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0020699 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0589114 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0278321 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0232970 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Contraceptives, Oral | Hormonal contraception | Vaginal contraception | Transdermal contraception | Contraceptive implant | Injectable contraception | Intrauterine Devices | Contraception, Barrier | Vaginal contraceptive diaphragm | Female Condoms | Vaginal Spermicides | Sexual Abstinence | Partner Infertility | Partner had vasectomy
Item
women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential
boolean
C0009905 (UMLS CUI [1])
C2985296 (UMLS CUI [2])
C0234007 (UMLS CUI [3])
C1168146 (UMLS CUI [4])
C1657106 (UMLS CUI [5])
C1262153 (UMLS CUI [6])
C0021900 (UMLS CUI [7])
C0004764 (UMLS CUI [8])
C0042241 (UMLS CUI [9])
C0221829 (UMLS CUI [10])
C0087145 (UMLS CUI [11])
C0036899 (UMLS CUI [12])
C0682323 (UMLS CUI [13,1])
C0021359 (UMLS CUI [13,2])
C0420842 (UMLS CUI [14])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Human chorionic gonadotropin measurement
Item
wocbp must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of human chorionic gonadotropin) within 72 hours prior to the start of investigational product
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C0428402 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Decompensated cirrhosis
Item
evidence of decompensated cirrhosis
boolean
C1619727 (UMLS CUI [1])
HIV coinfection | HCV coinfection | HDV Coinfection
Item
coinfection with human immunodeficiency virus, hepatitis c virus , or hepatitis d virus
boolean
C4062778 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
C0011220 (UMLS CUI [3,1])
C0275524 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Fertile | Sexually active Contraceptive methods Absent | Partner Childbearing Potential
Item
sexually active fertile men not using effective birth control if their partners were wocbp
boolean
C0079399 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0241028 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0682323 (UMLS CUI [3,1])
C3831118 (UMLS CUI [3,2])
Laboratory test result abnormal
Item
laboratory values out of protocol-specified range
boolean
C0438215 (UMLS CUI [1])
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