Information:
Fel:
ID
39557
Beskrivning
A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01590654
Länk
https://clinicaltrials.gov/show/NCT01590654
Nyckelord
Versioner (1)
- 2020-01-28 2020-01-28 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
28 januari 2020
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01590654
Eligibility Hepatitis B NCT01590654
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B NCT01590654
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Chronic Hepatitis B Disease length
Item
chronic hbv infection for ≥ 6 months
boolean
C0524909 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,2])
Oral medication Quantity | Pharmaceutical Preparations Hepatitis B Virus Approved | Lamivudine | telbivudine | entecavir | adefovir | Tenofovir
Item
currently on treatment with at least 1 hbv approved oral drug (i.e. lamivudine, telbivudine, entecavir, adefovir, tenofovir) ≥ 3 months prior to screening
boolean
C0175795 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0019169 (UMLS CUI [2,2])
C0205540 (UMLS CUI [2,3])
C0209738 (UMLS CUI [3])
C1453933 (UMLS CUI [4])
C0971023 (UMLS CUI [5])
C0050175 (UMLS CUI [6])
C0384228 (UMLS CUI [7])
C1265611 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0019169 (UMLS CUI [2,2])
C0205540 (UMLS CUI [2,3])
C0209738 (UMLS CUI [3])
C1453933 (UMLS CUI [4])
C0971023 (UMLS CUI [5])
C0050175 (UMLS CUI [6])
C0384228 (UMLS CUI [7])
Hepatitis B surface antigen measurement
Item
hbsag ≥ 250 iu/ml
boolean
C0201477 (UMLS CUI [1])
HBV DNA decreased
Item
hbv dna at below the level of quantitation (blq; to be confirmed at screening)
boolean
C1262160 (UMLS CUI [1])
Absence Bridging fibrosis Extensive | Metavir score | Liver Cirrhosis
Item
absence of extensive bridging fibrosis (metavir 3 or greater)or cirrhosis
boolean
C0332197 (UMLS CUI [1,1])
C0334160 (UMLS CUI [1,2])
C0205231 (UMLS CUI [1,3])
C3888527 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C0334160 (UMLS CUI [1,2])
C0205231 (UMLS CUI [1,3])
C3888527 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
Creatinine clearance measurement
Item
creatinine clearance ≥ 70 ml/min
boolean
C0373595 (UMLS CUI [1])
HCV coinfection | Coinfection Hepatitis Delta Virus | HIV coinfection
Item
co-infection with hepatitis c virus (hcv), hepatitis d virus (hdv), or hiv
boolean
C1698259 (UMLS CUI [1])
C0275524 (UMLS CUI [2,1])
C0011220 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
C0275524 (UMLS CUI [2,1])
C0011220 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Gilbert Disease
Item
history of gilberts disease
boolean
C0017551 (UMLS CUI [1])
Laboratory test result abnormal | Leukopenia | Neutropenia | Anemia | Thrombocytopenia | Thyroid-stimulating hormone | Hepatic decompensation
Item
laboratory parameters not within defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid-stimulating hormone (tsh), or other evidence of hepatic decompensation
boolean
C0438215 (UMLS CUI [1])
C0023530 (UMLS CUI [2])
C0027947 (UMLS CUI [3])
C0002871 (UMLS CUI [4])
C0040034 (UMLS CUI [5])
C0040160 (UMLS CUI [6])
C1394798 (UMLS CUI [7])
C0023530 (UMLS CUI [2])
C0027947 (UMLS CUI [3])
C0002871 (UMLS CUI [4])
C0040034 (UMLS CUI [5])
C0040160 (UMLS CUI [6])
C1394798 (UMLS CUI [7])
Autoimmune Disease | Poorly controlled diabetes mellitus | Mental disorders | Severe chronic obstructive pulmonary disease | Malignant Neoplasms | Hemoglobinopathy | Retinal Disease | Immunosuppressed patient
Item
diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (copd), malignancy, hemoglobinopathy, retinal disease, or patients who are immunosuppressed
boolean
C0004364 (UMLS CUI [1])
C0554876 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0730607 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
C0019045 (UMLS CUI [6])
C0035309 (UMLS CUI [7])
C0085393 (UMLS CUI [8])
C0554876 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0730607 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
C0019045 (UMLS CUI [6])
C0035309 (UMLS CUI [7])
C0085393 (UMLS CUI [8])
Liver carcinoma
Item
evidence of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])