ID

17501

Beskrivning

Safety and Antiviral Activity Study of Clevudine 30 Mg QD in Patients With HBeAg(-) Chronic HBV; ODM derived from: https://clinicaltrials.gov/show/NCT00313274

Länk

https://clinicaltrials.gov/show/NCT00313274

Nyckelord

  1. 2016-09-19 2016-09-19 -
Uppladdad den

19 september 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Hepatitis B NCT00313274

Eligibility Hepatitis B NCT00313274

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with hbv dna levels 1 x 105 copies/ml within 30 days of baseline.
Beskrivning

Hepatitis B DNA Measurement

Datatyp

boolean

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

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0200370
UMLS CUI [3]
C4049511
UMLS CUI [4]
C1096145
4. patients who were hbeag negative and hbeab positive.
Beskrivning

hbeag Negative | hbeab Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019167
UMLS CUI [1,2]
C1513916
UMLS CUI [2,1]
C0312634
UMLS CUI [2,2]
C1514241
5. patients with alt levels which were in the range of ≥1.2 and < 15 times the upper limit of normal (uln) and 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.
Beskrivning

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

Datatyp

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 childbearing potential with a negative serum (β-hcg) pregnancy test taken within 14 days of starting therapy.
Beskrivning

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

Datatyp

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.
Beskrivning

Informed Consent | Protocol Compliance

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
Beskrivning

Antiviral Therapy | Biological Response Modifier Therapy | Steroid therapy

Datatyp

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. previous treatment with interferon that had ended less than 6 months prior to the screening visit.
Beskrivning

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

Datatyp

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
UMLS CUI [7,1]
C0733470
UMLS CUI [7,2]
C1272693
3. patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
Beskrivning

Ascites | Bleeding varices | Hepatic Encephalopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2]
C0333106
UMLS CUI [3]
C0019151
4. patients coinfected with hcv, hdv or hiv.
Beskrivning

HCV coinfection | Coinfection HDV | HIV coinfection

Datatyp

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0011220
UMLS CUI [3]
C4062778
5. patients with clinical evidence of liver mass or with -fetoprotein > 50 ng/ml
Beskrivning

Liver mass Evidence Clinical | Alpha fetoprotein measurement

Datatyp

boolean

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

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. patients who were unwilling to use an “effective” method of contraception during the treatment period 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)
Beskrivning

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

Datatyp

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
8. patients with a clinically relevant history of abuse of alcohol or drugs.
Beskrivning

Substance Use Disorders Relevant Clinical

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
9. patients with a significant gastrointestinal, renal, hepatic (decompensated), broncho-pulmonary, biliary diseases except asymptomatic gb stone, neurological, cardiovascular, oncologic or allergic disease. the patient with a benign tumor was excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
Beskrivning

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

Datatyp

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
10. patients with creatinine clearance less than 60ml/min as estimated by the following formula:
Beskrivning

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

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]
Beskrivning

Age | Body Weight | Creatinine measurement, serum | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0005910
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0079399

Similar models

Eligibility Hepatitis B NCT00313274

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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 levels 1 x 105 copies/ml within 30 days of baseline.
boolean
C3641250 (UMLS CUI [1])
Hepatitis B surface antigen positive | Laboratory reporting | Anti-HBc IgM antibody negative | Anti-HBc IgG antibody positive
Item
3. patients who were documented to be hbsag positive for > 6 months (documentation of positive hbsag for the previous 6 months included previous laboratory reports showing hbsag positive at least 6 month ago or lab results showing igm anti-hbc negative and igg anti-hbc positive at screening).
boolean
C0149709 (UMLS CUI [1])
C0200370 (UMLS CUI [2])
C4049511 (UMLS CUI [3])
C1096145 (UMLS CUI [4])
hbeag Negative | hbeab Positive
Item
4. patients who were hbeag negative and hbeab positive.
boolean
C0019167 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0312634 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
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 the upper limit of normal (uln) and 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.
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 childbearing 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 | interferon Ended
Item
2. patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for hbv infection. previous treatment with interferon that had ended less than 6 months prior to the screening visit.
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])
C0733470 (UMLS CUI [7,1])
C1272693 (UMLS CUI [7,2])
Ascites | Bleeding varices | Hepatic Encephalopathy
Item
3. 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
4. patients 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 | Alpha fetoprotein measurement
Item
5. patients with clinical evidence of liver mass or with -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
6. 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
7. patients who were unwilling to use an “effective” method of contraception during the treatment period 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
8. 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 | Benign Neoplasm Interferes with Continuation Clinical Trial
Item
9. patients with a significant gastrointestinal, renal, hepatic (decompensated), broncho-pulmonary, biliary diseases except asymptomatic gb stone, neurological, cardiovascular, oncologic or allergic disease. the patient with a benign tumor was excluded if judged by an investigator that the continuation of study would be interfered by benign 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])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
10. 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])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial