ID

35981

Descripción

Compare Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With LAM-resistant Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT02482272

Link

https://clinicaltrials.gov/show/NCT02482272

Palabras clave

Versiones (1)
  1. 8/4/19 8/4/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

8 de abril de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT02482272

Inglés

Eligibility Hepatitis B, Chronic NCT02482272

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis b
Descripción

Hepatitis B, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0524909
age ≥ 20 year old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
currently taking lamivudine and adefovir combination therapy or adefovir monotherapy for chronic hbv infection for 24 weeks
Descripción

Lamivudine | adefovir | Combined Modality Therapy | Hepatitis B, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0209738
UMLS CUI [2]
C0050175
UMLS CUI [3]
C0009429
UMLS CUI [4]
C0524909
proven lamivudine resistant mutation
Descripción

Mutation Resistant to Lamivudine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026882
UMLS CUI [1,2]
C0332325
UMLS CUI [1,3]
C0209738
hbv dna levels at screening ≥ 15 iu/ml
Descripción

Hepatitis B DNA Measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3641250
females must be post-menopausal, unable to conceive, or test negative for pregnancy via urine test
Descripción

Postmenopausal state | Female infertility | Gender Urine pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0021361
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0430057
patient is able to give written informed consent prior to study start and to comply with the study requirements
Descripción

Informed Consent | Protocol Compliance

Tipo de datos

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
a history or current of decompensated cirrhosis or hepatocellular carcinoma
Descripción

Decompensated cirrhosis of liver | Liver carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1619727
UMLS CUI [2]
C2239176
currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy
Descripción

Antiviral Therapy | Immunomodulation | Cytotoxic therapy | Steroid therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0280274
UMLS CUI [2]
C1963758
UMLS CUI [3]
C0677881
UMLS CUI [4]
C0149783
co-infected with hcv or hiv
Descripción

HCV coinfection | HIV coinfection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2]
C4062778
a history of organ transplantation
Descripción

Organ Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029216
pregnant or breast-feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
current clinically relevant of abuse of alcohol or drugs.
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
significant immunocompromised, gastrointestinal, renal(serum creatinine ≥ 1.5 mg/dl), hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic, allergic disease or medical illness that in the investigator's opinion might interfere with therapy
Descripción

Immune System Diseases | Gastrointestinal Disease | Kidney Disease | Creatinine measurement, serum | Hematological Disease | Mental disorders | Bronchopulmonary disease | Biliary System Disorder | Exception CHOLELITHIASIS ASYMPTOMATIC | Nervous system disorder | Heart Disease | Malignant disease | Hypersensitivity | Illness Interferes with Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021053
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0018939
UMLS CUI [6]
C0004936
UMLS CUI [7]
C1096000
UMLS CUI [8]
C3275124
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0742393
UMLS CUI [10]
C0027765
UMLS CUI [11]
C0018799
UMLS CUI [12]
C0442867
UMLS CUI [13]
C0020517
UMLS CUI [14,1]
C0221423
UMLS CUI [14,2]
C0521102
UMLS CUI [14,3]
C0087111
malignancy in previous 5 years
Descripción

Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Hepatitis B, Chronic NCT02482272

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B, Chronic
Item
chronic hepatitis b
boolean
C0524909 (UMLS CUI [1])
Age
Item
age ≥ 20 year old
boolean
C0001779 (UMLS CUI [1])
Lamivudine | adefovir | Combined Modality Therapy | Hepatitis B, Chronic
Item
currently taking lamivudine and adefovir combination therapy or adefovir monotherapy for chronic hbv infection for 24 weeks
boolean
C0209738 (UMLS CUI [1])
C0050175 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0524909 (UMLS CUI [4])
Mutation Resistant to Lamivudine
Item
proven lamivudine resistant mutation
boolean
C0026882 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0209738 (UMLS CUI [1,3])
Hepatitis B DNA Measurement
Item
hbv dna levels at screening ≥ 15 iu/ml
boolean
C3641250 (UMLS CUI [1])
Postmenopausal state | Female infertility | Gender Urine pregnancy test negative
Item
females must be post-menopausal, unable to conceive, or test negative for pregnancy via urine test
boolean
C0232970 (UMLS CUI [1])
C0021361 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0430057 (UMLS CUI [3,2])
Informed Consent | Protocol Compliance
Item
patient is able to give written informed consent prior to study start and to comply with the study requirements
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Decompensated cirrhosis of liver | Liver carcinoma
Item
a history or current of decompensated cirrhosis or hepatocellular carcinoma
boolean
C1619727 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
Antiviral Therapy | Immunomodulation | Cytotoxic therapy | Steroid therapy
Item
currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy
boolean
C0280274 (UMLS CUI [1])
C1963758 (UMLS CUI [2])
C0677881 (UMLS CUI [3])
C0149783 (UMLS CUI [4])
HCV coinfection | HIV coinfection
Item
co-infected with hcv or hiv
boolean
C1698259 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Organ Transplantation
Item
a history of organ transplantation
boolean
C0029216 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Substance Use Disorders
Item
current clinically relevant of abuse of alcohol or drugs.
boolean
C0038586 (UMLS CUI [1])
Immune System Diseases | Gastrointestinal Disease | Kidney Disease | Creatinine measurement, serum | Hematological Disease | Mental disorders | Bronchopulmonary disease | Biliary System Disorder | Exception CHOLELITHIASIS ASYMPTOMATIC | Nervous system disorder | Heart Disease | Malignant disease | Hypersensitivity | Illness Interferes with Therapy
Item
significant immunocompromised, gastrointestinal, renal(serum creatinine ≥ 1.5 mg/dl), hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic, allergic disease or medical illness that in the investigator's opinion might interfere with therapy
boolean
C0021053 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
C1096000 (UMLS CUI [7])
C3275124 (UMLS CUI [8])
C1705847 (UMLS CUI [9,1])
C0742393 (UMLS CUI [9,2])
C0027765 (UMLS CUI [10])
C0018799 (UMLS CUI [11])
C0442867 (UMLS CUI [12])
C0020517 (UMLS CUI [13])
C0221423 (UMLS CUI [14,1])
C0521102 (UMLS CUI [14,2])
C0087111 (UMLS CUI [14,3])
Malignant Neoplasms
Item
malignancy in previous 5 years
boolean
C0006826 (UMLS CUI [1])
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