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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