ID

17506

Description

Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials; ODM derived from: https://clinicaltrials.gov/show/NCT00362505

Link

https://clinicaltrials.gov/show/NCT00362505

Keywords

Versions (1)
  1. 9/19/16 9/19/16 -
Uploaded on

September 19, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00362505

English

Eligibility Hepatitis B NCT00362505

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient is between 18 and 60, inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. patients who have completed l-fmau-301 or l-fmau-302 clinical trial.
Description

Clevudine Clinical Trial Complete

Data type

boolean

Alias
UMLS CUI [1,1]
C0045212
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205197
3. patient is hbsag positive at week 48 in l-fmau-301 or l-fmau-302.
Description

Hepatitis B surface antigen positive | Clevudine Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2,1]
C0045212
UMLS CUI [2,2]
C0008976
4. patient has bilirubin levels less than 2.0 mg/dl, prothrombin time of less than 1.7 (inr), a serum albumin level of at least 3.5 g/dl at week 48 in l-fmau-301 or l-fmau-302.
Description

Serum total bilirubin measurement | Prothrombin time | INR | Serum albumin measurement | Clevudine Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0033707
UMLS CUI [3]
C0525032
UMLS CUI [4]
C0523465
UMLS CUI [5,1]
C0045212
UMLS CUI [5,2]
C0008976
5. women of childbearing potential must have a negative serum (β-hcg) pregnancy test at screening.
Description

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

Data type

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
6. patient is able to give written informed consent prior to study start and to comply with the study requirements.
Description

Informed Consent | Protocol Compliance

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with hbv dna < 4,700 copies/ml, alt normalization and consecutive e seroconversion at week 40 and 48 in l-fmau-301
Description

Hepatitis B DNA Measurement | Alanine aminotransferase normal | Hepatitis B e Antigens Seroconversion | Clevudine Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C3641250
UMLS CUI [2]
C0855620
UMLS CUI [3,1]
C0019167
UMLS CUI [3,2]
C4042908
UMLS CUI [4,1]
C0045212
UMLS CUI [4,2]
C0008976
2. patients with hbv dna < 4,700 copies/ml and alt normalization in l-fmau-302
Description

Hepatitis B DNA Measurement | Alanine aminotransferase normal | Clevudine Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C3641250
UMLS CUI [2]
C0855620
UMLS CUI [3,1]
C0045212
UMLS CUI [3,2]
C0008976
3. patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
Description

Antiviral Therapy | Biological Response Modifier Therapy | Steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0280274
UMLS CUI [2]
C0005527
UMLS CUI [3]
C0149783
4. patients previously treated with α-interferon, lamivudine, lobucavir, adefovir or any other investigational nucleoside for hbv infection.
Description

Interferon-alpha | Lamivudine | lobucavir | adefovir | Nucleoside Investigational | Therapeutic procedure Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0002199
UMLS CUI [2]
C0209738
UMLS CUI [3]
C0286536
UMLS CUI [4]
C0050175
UMLS CUI [5,1]
C0028621
UMLS CUI [5,2]
C1517586
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C0019163
5. patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
Description

Ascites | Bleeding varices | Hepatic Encephalopathy

Data type

boolean

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

HCV coinfection | Coinfection HDV | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0011220
UMLS CUI [3]
C4062778
7. patient with clinical evidence of liver mass or hepatocellular carcinoma and
Description

Liver mass Evidence Clinical | Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0240225
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205210
UMLS CUI [2]
C2239176
α-fetoprotein > 50 ng/ml
Description

Alpha fetoprotein measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201539
8. patient is pregnant or breast-feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. 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) or post-menopausal or using at least medically acceptable barrier method of contraception (i.e. iud, barrier methods with spermicide or abstinence)
Description

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

Data type

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
10. patient has a clinically relevant history of abuse of alcohol or drugs.
Description

Substance Use Disorders Relevant Clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
11. patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases excluding asymptomic gb stone, neurological, cardiovascular, oncologic or allergic disease. the patient with a benign tumor except for liver mass, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
Description

Gastrointestinal Diseases Significant | Kidney Diseases | Decompensated liver disease | Bronchopulmonary disease | Gall Bladder Diseases | Cholelithiasis Asymptomatic | nervous system disorder | Cardiovascular Diseases | Malignant Neoplasms | Hypersensitivity | Benign Neoplasm Interferes with Continuation Clinical Trial | Liver mass

Data type

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
UMLS CUI [11,1]
C0086692
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0805733
UMLS CUI [11,4]
C0008976
UMLS CUI [12]
C0240225
12. patient has creatinine clearance less than 60ml/min as estimated by the following formula:
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

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]
Description

Age | Body Weight | Creatinine measurement, serum | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0005910
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0079399
13.patient whom investigator consider is not suitable in this study
Description

Patient Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Hepatitis B NCT00362505

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patient is between 18 and 60, inclusive
boolean
C0001779 (UMLS CUI [1])
Clevudine Clinical Trial Complete
Item
2. patients who have completed l-fmau-301 or l-fmau-302 clinical trial.
boolean
C0045212 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Hepatitis B surface antigen positive | Clevudine Clinical Trial
Item
3. patient is hbsag positive at week 48 in l-fmau-301 or l-fmau-302.
boolean
C0149709 (UMLS CUI [1])
C0045212 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Serum total bilirubin measurement | Prothrombin time | INR | Serum albumin measurement | Clevudine Clinical Trial
Item
4. patient has bilirubin levels less than 2.0 mg/dl, prothrombin time of less than 1.7 (inr), a serum albumin level of at least 3.5 g/dl at week 48 in l-fmau-301 or l-fmau-302.
boolean
C1278039 (UMLS CUI [1])
C0033707 (UMLS CUI [2])
C0525032 (UMLS CUI [3])
C0523465 (UMLS CUI [4])
C0045212 (UMLS CUI [5,1])
C0008976 (UMLS CUI [5,2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Serum Beta-HCG Test Negative
Item
5. women of childbearing potential must have a negative serum (β-hcg) pregnancy test at screening.
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
6. 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)
Hepatitis B DNA Measurement | Alanine aminotransferase normal | Hepatitis B e Antigens Seroconversion | Clevudine Clinical Trial
Item
1. patients with hbv dna < 4,700 copies/ml, alt normalization and consecutive e seroconversion at week 40 and 48 in l-fmau-301
boolean
C3641250 (UMLS CUI [1])
C0855620 (UMLS CUI [2])
C0019167 (UMLS CUI [3,1])
C4042908 (UMLS CUI [3,2])
C0045212 (UMLS CUI [4,1])
C0008976 (UMLS CUI [4,2])
Hepatitis B DNA Measurement | Alanine aminotransferase normal | Clevudine Clinical Trial
Item
2. patients with hbv dna < 4,700 copies/ml and alt normalization in l-fmau-302
boolean
C3641250 (UMLS CUI [1])
C0855620 (UMLS CUI [2])
C0045212 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
Antiviral Therapy | Biological Response Modifier Therapy | Steroid therapy
Item
3. patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
boolean
C0280274 (UMLS CUI [1])
C0005527 (UMLS CUI [2])
C0149783 (UMLS CUI [3])
Interferon-alpha | Lamivudine | lobucavir | adefovir | Nucleoside Investigational | Therapeutic procedure Hepatitis B
Item
4. patients previously treated with α-interferon, lamivudine, lobucavir, adefovir or any other investigational nucleoside for hbv infection.
boolean
C0002199 (UMLS CUI [1])
C0209738 (UMLS CUI [2])
C0286536 (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])
Ascites | Bleeding varices | Hepatic Encephalopathy
Item
5. 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
6. 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 mass Evidence Clinical | Liver carcinoma
Item
7. patient with clinical evidence of liver mass or hepatocellular carcinoma and
boolean
C0240225 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2])
Alpha fetoprotein measurement
Item
α-fetoprotein > 50 ng/ml
boolean
C0201539 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
8. 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
9. 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) 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
10. 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 | Gall Bladder Diseases | Cholelithiasis Asymptomatic | nervous system disorder | Cardiovascular Diseases | Malignant Neoplasms | Hypersensitivity | Benign Neoplasm Interferes with Continuation Clinical Trial | Liver mass
Item
11. patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases excluding asymptomic gb stone, neurological, cardiovascular, oncologic or allergic disease. the patient with a benign tumor except for liver mass, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
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])
C0086692 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0805733 (UMLS CUI [11,3])
C0008976 (UMLS CUI [11,4])
C0240225 (UMLS CUI [12])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
12. 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])
Patient Inappropriate
Item
13.patient whom investigator consider is not suitable in this study
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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