ID

17507

Description

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

Link

https://clinicaltrials.gov/show/NCT00362700

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 NCT00362700

English

Eligibility Hepatitis B NCT00362700

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Clevudine | l-fmau Clinical Trial

Data type

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.
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
3. 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
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
Description

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

Data type

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
Description

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)
Description

Hbv DNA Test Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C1256114
UMLS CUI [1,2]
C1513916
2. 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
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.
Description

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

Data type

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.
Description

Ascites | Bleeding varices | Hepatic Encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2]
C0333106
UMLS CUI [3]
C0019151
5. 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
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.
Description

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

Data type

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.
Description

Pregnancy | Breast Feeding

Data type

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)
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
9. 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
10. patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
Description

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

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]
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:
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
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Similar models

Eligibility Hepatitis B NCT00362700

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