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ID

16949

Description

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

Keywords

Versions (1)
  1. 8/15/16 8/15/16 -
Uploaded on

August 15, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Hepatitis B NCT00362674

    English

    Eligibility Hepatitis B NCT00362674

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

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

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

    Data type

    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.
    Description

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

    Data type

    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
    Description

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

    Data type

    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.
    Description

    Informed Consent

    Data type

    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.
    Description

    Bilirubin levels, prothrombin time, serum albumin

    Data type

    boolean

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

    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.
    Description

    Patients who have showed complete response but previously treated with placebo

    Data type

    boolean

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

    Antiviral, immunomodulatory or corticosteroid therapy

    Data type

    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.
    Description

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

    Data type

    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.
    Description

    Ascites, variceal hemorrhage or hepatic encephalopathy

    Data type

    boolean

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

    hcv, hdv or hiv infection

    Data type

    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.
    Description

    liver mass (hemangioma, nodule), biliary disease

    Data type

    boolean

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

    Pregnant or breast feeding

    Data type

    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.
    Description

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

    Data type

    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.
    Description

    Patients not suitable to the study

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1321605
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    Similar models

    Eligibility Hepatitis B NCT00362674

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
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