0 Evaluaciones
ID

16949

Descripción

Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00362674

Link

https://clinicaltrials.gov/show/NCT00362674

Palabras clave

Versiones (1)
  1. 15/8/16 15/8/16 -
Subido en

15 de agosto de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

    Sin comentarios

    Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

    Eligibility Hepatitis B NCT00362674

    Inglés

    Eligibility Hepatitis B NCT00362674

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. the patients who have completed l-fmau-301, l-fmau-302 or l-fmau-303.
    Descripción

    Patients who have completed l-fmau-301, l-fmau-302 or l-fmau-303

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    2. patients who have showed complete response (alt normalization and hbv dna <4,700 copies/ml in l-fmau-301 or l-fmau-302, in addition, hbeag seroconverted to anti-hbe at the last two visits in l-fmau-301) after completion of l-fmau-301 or l-fmau-302 and treated with the clevudine.
    Descripción

    patients who have showed complete response after completion of l-fmau-301 or l-fmau-302 and treated with the clevudine

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0201836
    UMLS CUI [2]
    C3641250
    UMLS CUI [3,1]
    C1167869
    UMLS CUI [3,2]
    C0019167
    3. patients who have showed complete response (alt normalization and hbv dna <4,700 copies/ml, in addition hbeag seroconverted to anti-hbe at the last two visits who showed hbeag positiv at baseline) after completion of l-fmau-303
    Descripción

    Patients who have showed complete response after completion of l-fmau-303

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0201836
    UMLS CUI [2]
    C3641250
    UMLS CUI [3,1]
    C1167869
    UMLS CUI [3,2]
    C0019167
    4. patients who were able to give written informed consent prior to study start and to comply with the study requirements.
    Descripción

    Informed Consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    5. patients with bilirubin levels less than 2.0 mg/dl, prothrombin time of less than 1.7 (inr), and a serum albumin level of at least 3.5 g/dl at the last visit in l-fmau-301, l-fmau-302 or l-fmau-303.
    Descripción

    Bilirubin levels, prothrombin time, serum albumin

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0344395
    UMLS CUI [2]
    C0033707
    UMLS CUI [3]
    C0523465
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. patients who have showed complete response but previously treated with placebo in the l-fmau-301, l-fmau-302.
    Descripción

    Patients who have showed complete response but previously treated with placebo

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0521982
    UMLS CUI [1,2]
    C0032042
    2. patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
    Descripción

    Antiviral, immunomodulatory or corticosteroid therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0280274
    UMLS CUI [2]
    C1963758
    UMLS CUI [3]
    C0149783
    3. patients previously treated with interferon, lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for hbv infection.
    Descripción

    interferon, lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for hbv infection.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021747
    UMLS CUI [2]
    C0209738
    UMLS CUI [3]
    C0286536
    UMLS CUI [4]
    C0209227
    UMLS CUI [5]
    C0050175
    UMLS CUI [6,1]
    C1579410
    UMLS CUI [6,2]
    C0019163
    4. patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
    Descripción

    Ascites, variceal hemorrhage or hepatic encephalopathy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0003962
    UMLS CUI [2]
    C0333106
    UMLS CUI [3]
    C0019151
    5. patients co-infected with hcv, hdv or hiv.
    Descripción

    hcv, hdv or hiv infection

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0019196
    UMLS CUI [2]
    C0011226
    UMLS CUI [3]
    C0019693
    6. patients with a liver mass (hemangioma, nodule), biliary diseases except asymptomatic gb stone during the l-fmau-301, l-fmau-302 or l-fmau-303.
    Descripción

    liver mass (hemangioma, nodule), biliary disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0238246
    UMLS CUI [2]
    C0745761
    UMLS CUI [3]
    C0016977
    7. patients who were pregnant or breast-feeding.
    Descripción

    Pregnant or breast feeding

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    8. patients with a significant gastrointestinal, renal, hepatic (decompensated), biliary diseases except asymptomatic gb stone, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease. the patients with a benign tumor were excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
    Descripción

    Significant gastrointestinal, renal, hepatic (decompensated), biliary diseases, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0017178
    UMLS CUI [2]
    C0022658
    UMLS CUI [3,1]
    C0023895
    UMLS CUI [3,2]
    C0205434
    UMLS CUI [4]
    C0016977
    UMLS CUI [5]
    C1096000
    UMLS CUI [6]
    C0027765
    UMLS CUI [7]
    C0007222
    UMLS CUI [8]
    C0027651
    UMLS CUI [9]
    C0020517
    9. patients who were not suitable to the study if judged by an investigator.
    Descripción

    Patients not suitable to the study

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    Volver a la parte superior de la página

    Similar models

    Eligibility Hepatitis B NCT00362674

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Patients who have completed l-fmau-301, l-fmau-302 or l-fmau-303
    Item
    1. the patients who have completed l-fmau-301, l-fmau-302 or l-fmau-303.
    boolean
    C2348568 (UMLS CUI [1])
    patients who have showed complete response after completion of l-fmau-301 or l-fmau-302 and treated with the clevudine
    Item
    2. patients who have showed complete response (alt normalization and hbv dna <4,700 copies/ml in l-fmau-301 or l-fmau-302, in addition, hbeag seroconverted to anti-hbe at the last two visits in l-fmau-301) after completion of l-fmau-301 or l-fmau-302 and treated with the clevudine.
    boolean
    C0201836 (UMLS CUI [1])
    C3641250 (UMLS CUI [2])
    C1167869 (UMLS CUI [3,1])
    C0019167 (UMLS CUI [3,2])
    Patients who have showed complete response after completion of l-fmau-303
    Item
    3. patients who have showed complete response (alt normalization and hbv dna <4,700 copies/ml, in addition hbeag seroconverted to anti-hbe at the last two visits who showed hbeag positiv at baseline) after completion of l-fmau-303
    boolean
    C0201836 (UMLS CUI [1])
    C3641250 (UMLS CUI [2])
    C1167869 (UMLS CUI [3,1])
    C0019167 (UMLS CUI [3,2])
    Informed Consent
    Item
    4. patients who were able to give written informed consent prior to study start and to comply with the study requirements.
    boolean
    C0021430 (UMLS CUI [1])
    Bilirubin levels, prothrombin time, serum albumin
    Item
    5. patients with bilirubin levels less than 2.0 mg/dl, prothrombin time of less than 1.7 (inr), and a serum albumin level of at least 3.5 g/dl at the last visit in l-fmau-301, l-fmau-302 or l-fmau-303.
    boolean
    C0344395 (UMLS CUI [1])
    C0033707 (UMLS CUI [2])
    C0523465 (UMLS CUI [3])
    Item Group
    C0680251 (UMLS CUI)
    Patients who have showed complete response but previously treated with placebo
    Item
    1. patients who have showed complete response but previously treated with placebo in the l-fmau-301, l-fmau-302.
    boolean
    C0521982 (UMLS CUI [1,1])
    C0032042 (UMLS CUI [1,2])
    Antiviral, immunomodulatory or corticosteroid therapy
    Item
    2. patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
    boolean
    C0280274 (UMLS CUI [1])
    C1963758 (UMLS CUI [2])
    C0149783 (UMLS CUI [3])
    interferon, lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for hbv infection.
    Item
    3. patients previously treated with interferon, lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for hbv infection.
    boolean
    C0021747 (UMLS CUI [1])
    C0209738 (UMLS CUI [2])
    C0286536 (UMLS CUI [3])
    C0209227 (UMLS CUI [4])
    C0050175 (UMLS CUI [5])
    C1579410 (UMLS CUI [6,1])
    C0019163 (UMLS CUI [6,2])
    Ascites, variceal hemorrhage or hepatic encephalopathy
    Item
    4. patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
    boolean
    C0003962 (UMLS CUI [1])
    C0333106 (UMLS CUI [2])
    C0019151 (UMLS CUI [3])
    hcv, hdv or hiv infection
    Item
    5. patients co-infected with hcv, hdv or hiv.
    boolean
    C0019196 (UMLS CUI [1])
    C0011226 (UMLS CUI [2])
    C0019693 (UMLS CUI [3])
    liver mass (hemangioma, nodule), biliary disease
    Item
    6. patients with a liver mass (hemangioma, nodule), biliary diseases except asymptomatic gb stone during the l-fmau-301, l-fmau-302 or l-fmau-303.
    boolean
    C0238246 (UMLS CUI [1])
    C0745761 (UMLS CUI [2])
    C0016977 (UMLS CUI [3])
    Pregnant or breast feeding
    Item
    7. patients who were pregnant or breast-feeding.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Significant gastrointestinal, renal, hepatic (decompensated), biliary diseases, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease
    Item
    8. patients with a significant gastrointestinal, renal, hepatic (decompensated), biliary diseases except asymptomatic gb stone, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease. the patients with a benign tumor were excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
    boolean
    C0017178 (UMLS CUI [1])
    C0022658 (UMLS CUI [2])
    C0023895 (UMLS CUI [3,1])
    C0205434 (UMLS CUI [3,2])
    C0016977 (UMLS CUI [4])
    C1096000 (UMLS CUI [5])
    C0027765 (UMLS CUI [6])
    C0007222 (UMLS CUI [7])
    C0027651 (UMLS CUI [8])
    C0020517 (UMLS CUI [9])
    Patients not suitable to the study
    Item
    9. patients who were not suitable to the study if judged by an investigator.
    boolean
    C1321605 (UMLS CUI [1])
    Volver a la parte superior de la página 

    Ayuda

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial