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])
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])