ID

20898

Beschreibung

Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30mg Versus Lamivudine 100mg for CHB Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00362635

Link

https://clinicaltrials.gov/show/NCT00362635

Stichworte

Versionen (1)
  1. 26.03.17 26.03.17 -
Hochgeladen am

26. März 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00362635

Englisch

Eligibility Hepatitis B NCT00362635

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patient is hbv dna positive with dna levels at screening >= 3 x 1,000,000 copies/ml.
Beschreibung

Hbv DNA Positive | Hepatitis B DNA Measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1256114
UMLS CUI [1,2]
C1514241
UMLS CUI [2]
C3641250
3. patient is documented to be hbsag positive for > 6 months and hbeag positive.
Beschreibung

Hepatitis B surface antigen positive | Hepatitis B e antigen positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0392390
4. patient has ast and alt levels which are >= 1 times and <= 10 times the upper limit of normal (x uln).
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
5. patient has bilirubin levels <= 1.5 x uln or bilirubin levels > 1.5 x uln with diagnosis of gilbert's disease and conjugated bilirubin within normal limits.
Beschreibung

Serum total bilirubin measurement | Gilbert Disease | Bilirubin conjugated normal

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0017551
UMLS CUI [3]
C0855626
6. women of childbearing age must have a negative urine (b-hcg) pregnancy test before start of trial treatment.
Beschreibung

Childbearing Potential Urine pregnancy test Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430056
UMLS CUI [1,3]
C1513916
7. patient is able to give written informed consent prior to study start and to comply with the study requirements.
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
Beschreibung

Antiviral Therapy | Biological Response Modifiers | Adrenal Cortex Hormones

Datentyp

boolean

Alias
UMLS CUI [1]
C0280274
UMLS CUI [2]
C0005525
UMLS CUI [3]
C0001617
2. patients previously treated with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for hbv infection.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0209738
UMLS CUI [2]
C0286536
UMLS CUI [3]
C0050175
UMLS CUI [4]
C0209227
UMLS CUI [5,1]
C0028621
UMLS CUI [5,2]
C1517586
UMLS CUI [6]
C0019163
3. previous treatment with interferon must have ended at least 6 months prior to the screening visit.
Beschreibung

Interferon To be stopped

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021747
UMLS CUI [1,2]
C1272691
4. patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
Beschreibung

Ascites | Bleeding varices | Hepatic Encephalopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2]
C0333106
UMLS CUI [3]
C0019151
5. patient is co-infected with hcv or hiv.
Beschreibung

HCV coinfection | HIV coinfection

Datentyp

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2]
C4062778
6. patient has evidence of decompensated cirrhosis or hepatocellular carcinoma (alpha fetoprotein).
Beschreibung

Decompensated cirrhosis Evidence of | Liver carcinoma | Alpha one fetoprotein measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1619727
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C2239176
UMLS CUI [3]
C0201539
7. patient is pregnant or breast-feeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

Substance Use Disorders

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0017178
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. subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening visit.
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
12. subjects who are taking any traditional chinese medication, or has been taking any traditional chinese medication within the last 2 weeks prior to screening visit.
Beschreibung

Pharmaceutical Preparation Traditional Chinese Medicine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0025124
13. any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
Beschreibung

Criteria Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C1299582
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Ähnliche Modelle

Eligibility Hepatitis B NCT00362635

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patient is between 18 and 60, inclusive.
boolean
C0001779 (UMLS CUI [1])
Hbv DNA Positive | Hepatitis B DNA Measurement
Item
2. patient is hbv dna positive with dna levels at screening >= 3 x 1,000,000 copies/ml.
boolean
C1256114 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C3641250 (UMLS CUI [2])
Hepatitis B surface antigen positive | Hepatitis B e antigen positive
Item
3. patient is documented to be hbsag positive for > 6 months and hbeag positive.
boolean
C0149709 (UMLS CUI [1])
C0392390 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
4. patient has ast and alt levels which are >= 1 times and <= 10 times the upper limit of normal (x uln).
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Serum total bilirubin measurement | Gilbert Disease | Bilirubin conjugated normal
Item
5. patient has bilirubin levels <= 1.5 x uln or bilirubin levels > 1.5 x uln with diagnosis of gilbert's disease and conjugated bilirubin within normal limits.
boolean
C1278039 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
C0855626 (UMLS CUI [3])
Childbearing Potential Urine pregnancy test Negative
Item
6. women of childbearing age must have a negative urine (b-hcg) pregnancy test before start of trial treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Informed Consent | Protocol Compliance
Item
7. 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)
Antiviral Therapy | Biological Response Modifiers | Adrenal Cortex Hormones
Item
1. patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
boolean
C0280274 (UMLS CUI [1])
C0005525 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
Lamivudine | lobucavir | adefovir | famciclovir | Nucleoside Investigational | Hepatitis B
Item
2. patients previously treated with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for hbv infection.
boolean
C0209738 (UMLS CUI [1])
C0286536 (UMLS CUI [2])
C0050175 (UMLS CUI [3])
C0209227 (UMLS CUI [4])
C0028621 (UMLS CUI [5,1])
C1517586 (UMLS CUI [5,2])
C0019163 (UMLS CUI [6])
Interferon To be stopped
Item
3. previous treatment with interferon must have ended at least 6 months prior to the screening visit.
boolean
C0021747 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
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 | HIV coinfection
Item
5. patient is co-infected with hcv or hiv.
boolean
C1698259 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Decompensated cirrhosis Evidence of | Liver carcinoma | Alpha one fetoprotein measurement
Item
6. patient has evidence of decompensated cirrhosis or hepatocellular carcinoma (alpha fetoprotein).
boolean
C1619727 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2])
C0201539 (UMLS CUI [3])
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
Item
9. patient has a clinically relevant history of abuse of alcohol or drugs.
boolean
C0038586 (UMLS CUI [1])
Gastrointestinal Diseases | 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])
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])
Study Subject Participation Status | Investigational New Drugs
Item
11. subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening visit.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pharmaceutical Preparation Traditional Chinese Medicine
Item
12. subjects who are taking any traditional chinese medication, or has been taking any traditional chinese medication within the last 2 weeks prior to screening visit.
boolean
C0013227 (UMLS CUI [1,1])
C0025124 (UMLS CUI [1,2])
Criteria Protocol Compliance Unable
Item
13. any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
boolean
C0243161 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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