ID

17502

Descrizione

Safety and Antiviral Activity Study of Clevudine 30 Mg QD in Patient With Chronic HBV; ODM derived from: https://clinicaltrials.gov/show/NCT00313287

collegamento

https://clinicaltrials.gov/show/NCT00313287

Keywords

versioni (1)
  1. 19/09/16 19/09/16 -
Caricato su

19 settembre 2016

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00313287

Inglese

Eligibility Hepatitis B NCT00313287

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients who were between 18 and 60, inclusive.
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with hbv dna ³1 x 106 copies/ml within 30 days of baseline.
Descrizione

Hepatitis B DNA Measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3641250
3. patients who were documented to be hbsag positive for > 6 months. (the documentation of positive hbsag for the previous 6 months included previous laboratory reports of hbsag positive or hbeag positive at least 6 month ago or igm anti-hbc negative and igg anti-hbc positive at screening).
Descrizione

Hepatitis B surface antigen positive | Laboratory reporting | Hepatitis B e antigen positive | Anti-HBc IgM antibody negative | Anti-HBc IgG antibody positive

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0200370
UMLS CUI [3]
C0392390
UMLS CUI [4]
C4049511
UMLS CUI [5]
C1096145
4. patients who were hbeag positive.
Descrizione

Hepatitis B e antigen positive

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0392390
5. patients with alt levels which were in the range of ≥1.2 and < 15 times of the upper limit of normal (x uln) and 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.
Descrizione

Alanine aminotransferase measurement | Serum total bilirubin measurement | Prothrombin time | INR | Serum albumin measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0033707
UMLS CUI [4]
C0525032
UMLS CUI [5]
C0523465
6. women of child bearing potential with a negative serum (β-hcg) pregnancy test taken 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
7. patients who were 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
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who were 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
2. patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for hbv infection.
Descrizione

Lamivudine | lobucavir | famciclovir | adefovir | Nucleoside Investigational | Therapeutic procedure Hepatitis B

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0209738
UMLS CUI [2]
C0286536
UMLS CUI [3]
C0209227
UMLS CUI [4]
C0050175
UMLS CUI [5,1]
C0028621
UMLS CUI [5,2]
C1517586
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C0019163
3. previous treatment with interferon that had ended less than 6 months prior to the screening visit.
Descrizione

interferon Ended

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0733470
UMLS CUI [1,2]
C1272693
4. patients with 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. patients co-infected 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. patients with clinical evidence of liver mass or with alpha-fetoprotein > 50 ng/ml
Descrizione

Liver mass Evidence Clinical | Alpha fetoprotein measurement

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0240225
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205210
UMLS CUI [2]
C0201539
7. patients who were pregnant or breast-feeding.
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. patients who were unwilling to use an “effective” method of contraception during the treatment and for up to 3 months after cessation of therapy. for males, condoms should be used. females had to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least 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. patients with 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. patients with a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases except asymptomatic gb stone, neurological, cardiovascular, oncologic or allergic disease.
Descrizione

Gastrointestinal Diseases Significant | Kidney Diseases | Decompensated liver disease | Bronchopulmonary disease | Gall Bladder Diseases | Cholelithiasis Asymptomatic | 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]
C0016977
UMLS CUI [6,1]
C0008350
UMLS CUI [6,2]
C0231221
UMLS CUI [7]
C0027765
UMLS CUI [8]
C0007222
UMLS CUI [9]
C0006826
UMLS CUI [10]
C0020517
the patients with a benign tumor were excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
Descrizione

Benign Neoplasm Interferes with Continuation Clinical Trial

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0086692
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0805733
UMLS CUI [1,4]
C0008976
11. patients with 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
patients who were found to have ymdd hbv dna polymerase mutation at baseline were to be excluded from the overall efficacy evaluation and analyzed separately. they were to be included in the overall safety evaluation.
Descrizione

Hepatitis B virus YMDD mutation DNA Polymerase

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1717884
UMLS CUI [1,2]
C0012892
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Similar models

Eligibility Hepatitis B NCT00313287

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients who were between 18 and 60, inclusive.
boolean
C0001779 (UMLS CUI [1])
Hepatitis B DNA Measurement
Item
2. patients with hbv dna ³1 x 106 copies/ml within 30 days of baseline.
boolean
C3641250 (UMLS CUI [1])
Hepatitis B surface antigen positive | Laboratory reporting | Hepatitis B e antigen positive | Anti-HBc IgM antibody negative | Anti-HBc IgG antibody positive
Item
3. patients who were documented to be hbsag positive for > 6 months. (the documentation of positive hbsag for the previous 6 months included previous laboratory reports of hbsag positive or hbeag positive at least 6 month ago or igm anti-hbc negative and igg anti-hbc positive at screening).
boolean
C0149709 (UMLS CUI [1])
C0200370 (UMLS CUI [2])
C0392390 (UMLS CUI [3])
C4049511 (UMLS CUI [4])
C1096145 (UMLS CUI [5])
Hepatitis B e antigen positive
Item
4. patients who were hbeag positive.
boolean
C0392390 (UMLS CUI [1])
Alanine aminotransferase measurement | Serum total bilirubin measurement | Prothrombin time | INR | Serum albumin measurement
Item
5. patients with alt levels which were in the range of ≥1.2 and < 15 times of the upper limit of normal (x uln) and 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.
boolean
C0201836 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0033707 (UMLS CUI [3])
C0525032 (UMLS CUI [4])
C0523465 (UMLS CUI [5])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Serum Beta-HCG Test Negative
Item
6. women of child bearing potential with a negative serum (β-hcg) pregnancy test taken 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
7. 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])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Antiviral Therapy | Biological Response Modifier Therapy | Steroid therapy
Item
1. patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
boolean
C0280274 (UMLS CUI [1])
C0005527 (UMLS CUI [2])
C0149783 (UMLS CUI [3])
Lamivudine | lobucavir | famciclovir | adefovir | Nucleoside Investigational | Therapeutic procedure Hepatitis B
Item
2. patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for hbv infection.
boolean
C0209738 (UMLS CUI [1])
C0286536 (UMLS CUI [2])
C0209227 (UMLS CUI [3])
C0050175 (UMLS CUI [4])
C0028621 (UMLS CUI [5,1])
C1517586 (UMLS CUI [5,2])
C0087111 (UMLS CUI [6,1])
C0019163 (UMLS CUI [6,2])
interferon Ended
Item
3. previous treatment with interferon that had ended less than 6 months prior to the screening visit.
boolean
C0733470 (UMLS CUI [1,1])
C1272693 (UMLS CUI [1,2])
Ascites | Bleeding varices | 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 coinfection | Coinfection HDV | HIV coinfection
Item
5. patients co-infected 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 mass Evidence Clinical | Alpha fetoprotein measurement
Item
6. patients with clinical evidence of liver mass or with alpha-fetoprotein > 50 ng/ml
boolean
C0240225 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0201539 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
7. patients who were 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. patients who were unwilling to use an “effective” method of contraception during the treatment and for up to 3 months after cessation of therapy. for males, condoms should be used. females had to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least 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. patients with 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 | Gall Bladder Diseases | Cholelithiasis Asymptomatic | nervous system disorder | Cardiovascular Diseases | Malignant Neoplasms | Hypersensitivity
Item
10. patients with a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases except asymptomatic gb stone, 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])
C0016977 (UMLS CUI [5])
C0008350 (UMLS CUI [6,1])
C0231221 (UMLS CUI [6,2])
C0027765 (UMLS CUI [7])
C0007222 (UMLS CUI [8])
C0006826 (UMLS CUI [9])
C0020517 (UMLS CUI [10])
Benign Neoplasm Interferes with Continuation Clinical Trial
Item
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
C0086692 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0805733 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
11. patients with 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])
Hepatitis B virus YMDD mutation DNA Polymerase
Item
patients who were found to have ymdd hbv dna polymerase mutation at baseline were to be excluded from the overall efficacy evaluation and analyzed separately. they were to be included in the overall safety evaluation.
boolean
C1717884 (UMLS CUI [1,1])
C0012892 (UMLS CUI [1,2])
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