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ID

17507

Descrizione

Safety and Efficacy Study of Retreated Clevudine in Chronic HBV Patients Who Received Clevudine in L-FMAU-201; ODM derived from: https://clinicaltrials.gov/show/NCT00362700

collegamento

https://clinicaltrials.gov/show/NCT00362700

Keywords

versioni (1)
  1. 19/09/16 19/09/16 -
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19 settembre 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Hepatitis B NCT00362700

    Inglese

    Eligibility Hepatitis B NCT00362700

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients who received clevudine in l-fmau-201 clinical trial (phase iib)
    Descrizione

    Clevudine | l-fmau Clinical Trial

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0045212
    UMLS CUI [2,1]
    C0045212
    UMLS CUI [2,2]
    C0008976
    2. female of childbearing potential must have a negative serum ( b-hcg) pregnancy test within 14 days of starting therapy.
    Descrizione

    Childbearing Potential Serum pregnancy test negative | Childbearing Potential Serum Beta-HCG Test Negative

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0430061
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C1255526
    UMLS CUI [2,3]
    C1513916
    3. patient is able to give written informed consent prior to study start and to comply with the study requirements.
    Descrizione

    Informed Consent | Protocol Compliance

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2]
    C0525058
    4. patients who met the following criteria after completion of the week 48 visit were to have additional follow-up visits at weeks 54 and 60: 1) had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a > 1 log10 decrease from baseline in hbv dna at week 48
    Descrizione

    Patient Visit | Follow-up visit Additional | Additional Therapy | Clevudine | HBV DNA decreased

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1512346
    UMLS CUI [2,1]
    C0589121
    UMLS CUI [2,2]
    C1524062
    UMLS CUI [3]
    C1706712
    UMLS CUI [4]
    C0045212
    UMLS CUI [5]
    C1262160
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. hbv dna negative (< 4,700 copies/ml) consistently at the last 2 visit (at least 2 consecutive visits, at one month interval)
    Descrizione

    Hbv DNA Test Negative

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1256114
    UMLS CUI [1,2]
    C1513916
    2. patient is currently receiving antiviral immunomodulatory or corticosteroid therapy.
    Descrizione

    Antiviral Therapy | Biological Response Modifier Therapy | Steroid therapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0280274
    UMLS CUI [2]
    C0005527
    UMLS CUI [3]
    C0149783
    3. patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for hbv infection after cessation of treatment in l-fmau-201 study.
    Descrizione

    Lamivudine | lobucavir | adefovir | Nucleoside Investigational | Therapeutic procedure Hepatitis B | Clevudine Clinical Trial Therapeutic procedure Ended

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0209738
    UMLS CUI [2]
    C0286536
    UMLS CUI [3]
    C0050175
    UMLS CUI [4,1]
    C0028621
    UMLS CUI [4,2]
    C1517586
    UMLS CUI [5,1]
    C0087111
    UMLS CUI [5,2]
    C0019163
    UMLS CUI [6,1]
    C0045212
    UMLS CUI [6,2]
    C0008976
    UMLS CUI [6,3]
    C0087111
    UMLS CUI [6,4]
    C1272693
    4. patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
    Descrizione

    Ascites | Bleeding varices | Hepatic Encephalopathy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0003962
    UMLS CUI [2]
    C0333106
    UMLS CUI [3]
    C0019151
    5. patient is coinfected with hcv, hdv or hiv.
    Descrizione

    HCV coinfection | Coinfection HDV | HIV coinfection

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1698259
    UMLS CUI [2,1]
    C0275524
    UMLS CUI [2,2]
    C0011220
    UMLS CUI [3]
    C4062778
    6. patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-fetoprotein) evaluation will be based on alpha-fetoprotein primarily. if alpha-fetoprotein level is suggestive of cirrhosis or hepatocellular carcinoma, confirmation will be made with sonography etc.
    Descrizione

    Liver Cirrhosis Evidence Clinical | Liver carcinoma Evidence Clinical | Alpha fetoprotein measurement | Sonography

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0023890
    UMLS CUI [1,2]
    C3887511
    UMLS CUI [1,3]
    C0205210
    UMLS CUI [2,1]
    C2239176
    UMLS CUI [2,2]
    C3887511
    UMLS CUI [2,3]
    C0205210
    UMLS CUI [3]
    C0201539
    UMLS CUI [4]
    C0041618
    7. patient is pregnant or breast-feeding.
    Descrizione

    Pregnancy | Breast Feeding

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    8. patient is unwilling to use an “effective” method of contraception during the study and for up to 3 months after the use of study drug ceases. for males, condoms should be used. females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal or using at least a medically acceptable barrier method of contraception (i.e., iud, barrier methods with spermicide or abstinence)
    Descrizione

    Contraceptive methods Unwilling | Condoms, Male | Female Sterilization | Hysterectomy | Bilateral tubal ligation | Postmenopausal state | Contraception, Barrier | Intrauterine Devices | Vaginal Spermicides | Sexual Abstinence

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0700589
    UMLS CUI [1,2]
    C0558080
    UMLS CUI [2]
    C0009653
    UMLS CUI [3]
    C0015787
    UMLS CUI [4]
    C0020699
    UMLS CUI [5]
    C0589114
    UMLS CUI [6]
    C0232970
    UMLS CUI [7]
    C0004764
    UMLS CUI [8]
    C0021900
    UMLS CUI [9]
    C0087145
    UMLS CUI [10]
    C0036899
    9. patient has a clinically relevant history of abuse of alcohol or drugs.
    Descrizione

    Substance Use Disorders Relevant Clinical

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0038586
    UMLS CUI [1,2]
    C2347946
    UMLS CUI [1,3]
    C0205210
    10. patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
    Descrizione

    Gastrointestinal Diseases Significant | Kidney Diseases | Decompensated liver disease | Bronchopulmonary disease | nervous system disorder | Cardiovascular Diseases | Malignant Neoplasms | Hypersensitivity

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0017178
    UMLS CUI [1,2]
    C0750502
    UMLS CUI [2]
    C0022658
    UMLS CUI [3]
    C4075847
    UMLS CUI [4]
    C1096000
    UMLS CUI [5]
    C0027765
    UMLS CUI [6]
    C0007222
    UMLS CUI [7]
    C0006826
    UMLS CUI [8]
    C0020517
    11. patient has creatinine clearance less than 60ml/min as estimated by the following formula:
    Descrizione

    Estimation of creatinine clearance by Cockcroft-Gault formula

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2711451
    (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dl]) [note: multiply estimates by 0.85 for women]
    Descrizione

    Age | Body Weight | Creatinine measurement, serum | Gender

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0005910
    UMLS CUI [3]
    C0201976
    UMLS CUI [4]
    C0079399
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    Similar models

    Eligibility Hepatitis B NCT00362700

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Clevudine | l-fmau Clinical Trial
    Item
    1. patients who received clevudine in l-fmau-201 clinical trial (phase iib)
    boolean
    C0045212 (UMLS CUI [1])
    C0045212 (UMLS CUI [2,1])
    C0008976 (UMLS CUI [2,2])
    Childbearing Potential Serum pregnancy test negative | Childbearing Potential Serum Beta-HCG Test Negative
    Item
    2. female of childbearing potential must have a negative serum ( b-hcg) pregnancy test within 14 days of starting therapy.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0430061 (UMLS CUI [1,2])
    C3831118 (UMLS CUI [2,1])
    C1255526 (UMLS CUI [2,2])
    C1513916 (UMLS CUI [2,3])
    Informed Consent | Protocol Compliance
    Item
    3. 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])
    Patient Visit | Follow-up visit Additional | Additional Therapy | Clevudine | HBV DNA decreased
    Item
    4. patients who met the following criteria after completion of the week 48 visit were to have additional follow-up visits at weeks 54 and 60: 1) had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a > 1 log10 decrease from baseline in hbv dna at week 48
    boolean
    C1512346 (UMLS CUI [1])
    C0589121 (UMLS CUI [2,1])
    C1524062 (UMLS CUI [2,2])
    C1706712 (UMLS CUI [3])
    C0045212 (UMLS CUI [4])
    C1262160 (UMLS CUI [5])
    Item Group
    C0680251 (UMLS CUI)
    Hbv DNA Test Negative
    Item
    1. hbv dna negative (< 4,700 copies/ml) consistently at the last 2 visit (at least 2 consecutive visits, at one month interval)
    boolean
    C1256114 (UMLS CUI [1,1])
    C1513916 (UMLS CUI [1,2])
    Antiviral Therapy | Biological Response Modifier Therapy | Steroid therapy
    Item
    2. patient is currently receiving antiviral immunomodulatory or corticosteroid therapy.
    boolean
    C0280274 (UMLS CUI [1])
    C0005527 (UMLS CUI [2])
    C0149783 (UMLS CUI [3])
    Lamivudine | lobucavir | adefovir | Nucleoside Investigational | Therapeutic procedure Hepatitis B | Clevudine Clinical Trial Therapeutic procedure Ended
    Item
    3. patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for hbv infection after cessation of treatment in l-fmau-201 study.
    boolean
    C0209738 (UMLS CUI [1])
    C0286536 (UMLS CUI [2])
    C0050175 (UMLS CUI [3])
    C0028621 (UMLS CUI [4,1])
    C1517586 (UMLS CUI [4,2])
    C0087111 (UMLS CUI [5,1])
    C0019163 (UMLS CUI [5,2])
    C0045212 (UMLS CUI [6,1])
    C0008976 (UMLS CUI [6,2])
    C0087111 (UMLS CUI [6,3])
    C1272693 (UMLS CUI [6,4])
    Ascites | Bleeding varices | Hepatic Encephalopathy
    Item
    4. patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
    boolean
    C0003962 (UMLS CUI [1])
    C0333106 (UMLS CUI [2])
    C0019151 (UMLS CUI [3])
    HCV coinfection | Coinfection HDV | HIV coinfection
    Item
    5. patient is coinfected with hcv, hdv or hiv.
    boolean
    C1698259 (UMLS CUI [1])
    C0275524 (UMLS CUI [2,1])
    C0011220 (UMLS CUI [2,2])
    C4062778 (UMLS CUI [3])
    Liver Cirrhosis Evidence Clinical | Liver carcinoma Evidence Clinical | Alpha fetoprotein measurement | Sonography
    Item
    6. patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-fetoprotein) evaluation will be based on alpha-fetoprotein primarily. if alpha-fetoprotein level is suggestive of cirrhosis or hepatocellular carcinoma, confirmation will be made with sonography etc.
    boolean
    C0023890 (UMLS CUI [1,1])
    C3887511 (UMLS CUI [1,2])
    C0205210 (UMLS CUI [1,3])
    C2239176 (UMLS CUI [2,1])
    C3887511 (UMLS CUI [2,2])
    C0205210 (UMLS CUI [2,3])
    C0201539 (UMLS CUI [3])
    C0041618 (UMLS CUI [4])
    Pregnancy | Breast Feeding
    Item
    7. patient is pregnant or breast-feeding.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Contraceptive methods Unwilling | Condoms, Male | Female Sterilization | Hysterectomy | Bilateral tubal ligation | Postmenopausal state | Contraception, Barrier | Intrauterine Devices | Vaginal Spermicides | Sexual Abstinence
    Item
    8. patient is unwilling to use an “effective” method of contraception during the study and for up to 3 months after the use of study drug ceases. for males, condoms should be used. females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal or using at least a medically acceptable barrier method of contraception (i.e., iud, barrier methods with spermicide or abstinence)
    boolean
    C0700589 (UMLS CUI [1,1])
    C0558080 (UMLS CUI [1,2])
    C0009653 (UMLS CUI [2])
    C0015787 (UMLS CUI [3])
    C0020699 (UMLS CUI [4])
    C0589114 (UMLS CUI [5])
    C0232970 (UMLS CUI [6])
    C0004764 (UMLS CUI [7])
    C0021900 (UMLS CUI [8])
    C0087145 (UMLS CUI [9])
    C0036899 (UMLS CUI [10])
    Substance Use Disorders Relevant Clinical
    Item
    9. patient has a clinically relevant history of abuse of alcohol or drugs.
    boolean
    C0038586 (UMLS CUI [1,1])
    C2347946 (UMLS CUI [1,2])
    C0205210 (UMLS CUI [1,3])
    Gastrointestinal Diseases Significant | Kidney Diseases | Decompensated liver disease | Bronchopulmonary disease | nervous system disorder | Cardiovascular Diseases | Malignant Neoplasms | Hypersensitivity
    Item
    10. patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
    boolean
    C0017178 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    C0022658 (UMLS CUI [2])
    C4075847 (UMLS CUI [3])
    C1096000 (UMLS CUI [4])
    C0027765 (UMLS CUI [5])
    C0007222 (UMLS CUI [6])
    C0006826 (UMLS CUI [7])
    C0020517 (UMLS CUI [8])
    Estimation of creatinine clearance by Cockcroft-Gault formula
    Item
    11. patient has creatinine clearance less than 60ml/min as estimated by the following formula:
    boolean
    C2711451 (UMLS CUI [1])
    Age | Body Weight | Creatinine measurement, serum | Gender
    Item
    (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dl]) [note: multiply estimates by 0.85 for women]
    boolean
    C0001779 (UMLS CUI [1])
    C0005910 (UMLS CUI [2])
    C0201976 (UMLS CUI [3])
    C0079399 (UMLS CUI [4])
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