ID

39557

Descripción

A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01590654

Link

https://clinicaltrials.gov/show/NCT01590654

Palabras clave

Versiones (1)
  1. 28/1/20 28/1/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

28 de enero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01590654

Inglés

Eligibility Hepatitis B NCT01590654

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hbv infection for ≥ 6 months
Descripción

Chronic Hepatitis B Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0872146
currently on treatment with at least 1 hbv approved oral drug (i.e. lamivudine, telbivudine, entecavir, adefovir, tenofovir) ≥ 3 months prior to screening
Descripción

Oral medication Quantity | Pharmaceutical Preparations Hepatitis B Virus Approved | Lamivudine | telbivudine | entecavir | adefovir | Tenofovir

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0019169
UMLS CUI [2,3]
C0205540
UMLS CUI [3]
C0209738
UMLS CUI [4]
C1453933
UMLS CUI [5]
C0971023
UMLS CUI [6]
C0050175
UMLS CUI [7]
C0384228
hbsag ≥ 250 iu/ml
Descripción

Hepatitis B surface antigen measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201477
hbv dna at below the level of quantitation (blq; to be confirmed at screening)
Descripción

HBV DNA decreased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1262160
absence of extensive bridging fibrosis (metavir 3 or greater)or cirrhosis
Descripción

Absence Bridging fibrosis Extensive | Metavir score | Liver Cirrhosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0334160
UMLS CUI [1,3]
C0205231
UMLS CUI [2]
C3888527
UMLS CUI [3]
C0023890
creatinine clearance ≥ 70 ml/min
Descripción

Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0373595
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection with hepatitis c virus (hcv), hepatitis d virus (hdv), or hiv
Descripción

HCV coinfection | Coinfection Hepatitis Delta Virus | HIV coinfection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0011220
UMLS CUI [3]
C4062778
history of gilberts disease
Descripción

Gilbert Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017551
laboratory parameters not within defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid-stimulating hormone (tsh), or other evidence of hepatic decompensation
Descripción

Laboratory test result abnormal | Leukopenia | Neutropenia | Anemia | Thrombocytopenia | Thyroid-stimulating hormone | Hepatic decompensation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0023530
UMLS CUI [3]
C0027947
UMLS CUI [4]
C0002871
UMLS CUI [5]
C0040034
UMLS CUI [6]
C0040160
UMLS CUI [7]
C1394798
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
Descripción

Autoimmune Disease | Poorly controlled diabetes mellitus | Mental disorders | Severe chronic obstructive pulmonary disease | Malignant Neoplasms | Hemoglobinopathy | Retinal Disease | Immunosuppressed patient

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0554876
UMLS CUI [3]
C0004936
UMLS CUI [4]
C0730607
UMLS CUI [5]
C0006826
UMLS CUI [6]
C0019045
UMLS CUI [7]
C0035309
UMLS CUI [8]
C0085393
evidence of hepatocellular carcinoma
Descripción

Liver carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2239176
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Similar models

Eligibility Hepatitis B NCT01590654

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis B Disease length
Item
chronic hbv infection for ≥ 6 months
boolean
C0524909 (UMLS CUI [1,1])
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])
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])
Creatinine clearance measurement
Item
creatinine clearance ≥ 70 ml/min
boolean
C0373595 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
Liver carcinoma
Item
evidence of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
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