ID

17490

Description

Safety and Efficacy Study of L-FMAU in Chronic HBV Patients of L-FMAU-201 Placebo Group; ODM derived from: https://clinicaltrials.gov/show/NCT00313261

Link

https://clinicaltrials.gov/show/NCT00313261

Keywords

Versions (1)
  1. 9/18/16 9/18/16 -
Uploaded on

September 18, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hepatitis B NCT00313261

English

Eligibility Hepatitis B NCT00313261

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients who received placebo in l-fmau-201 study
Description

Placebo given Clinical Trial l-fmau

Data type

boolean

Alias
UMLS CUI [1,1]
C0420256
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0045212
2. female of childbearing potential with a negative serum (beta-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. patients who were 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:
Description

Patient Visit Complete | Follow-up visit Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0589121
UMLS CUI [2,2]
C1524062
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

Clevudine | HBV DNA decreased

Data type

boolean

Alias
UMLS CUI [1]
C0045212
UMLS CUI [2]
C1262160
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient with hbeag seroconverted to anti-hbe at the last 2 consecutive visits (one month apart) in l-fmau-201 study.
Description

Hepatitis B e Antigens Seroconversion Antibody to hepatitis Be antigen

Data type

boolean

Alias
UMLS CUI [1,1]
C0019167
UMLS CUI [1,2]
C4042908
UMLS CUI [1,3]
C0312634
2. patient who was 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. patient who was treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for hbv infection after cessation of treatment in l-fmau-201 study.
Description

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

Data type

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
4. patient who had 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 who was co-infected 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 was based on alpha-fetoprotein primarily. if alpha-fetoprotein level was suggestive of cirrhosis or hepatocellular carcinoma, confirmation was made with ultrasonography etc.
Description

Liver Cirrhosis Evidence of | Liver carcinoma Evidence of | Alpha-fetoprotein measurement | Ultrasonography

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0332120
UMLS CUI [3]
C0201539
UMLS CUI [4]
C0041618
7. patient who was pregnant or breast-feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. patient who was unwilling to use an "effective" method of contraception during treatment period and for up to 3 months after cessation of therapy. 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 supermicide 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 who had a clinically relevant history of abuse of alcohol or drugs.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
10. patient who had 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 who had 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
Back to the top of the page

Similar models

Eligibility Hepatitis B NCT00313261

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Placebo given Clinical Trial l-fmau
Item
1. patients who received placebo in l-fmau-201 study
boolean
C0420256 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0045212 (UMLS CUI [1,3])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Serum Beta-HCG Test Negative
Item
2. female of childbearing potential with a negative serum (beta-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. 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])
Patient Visit Complete | Follow-up visit Additional
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:
boolean
C1512346 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0589121 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
Clevudine | HBV DNA decreased
Item
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
C0045212 (UMLS CUI [1])
C1262160 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hepatitis B e Antigens Seroconversion Antibody to hepatitis Be antigen
Item
1. patient with hbeag seroconverted to anti-hbe at the last 2 consecutive visits (one month apart) in l-fmau-201 study.
boolean
C0019167 (UMLS CUI [1,1])
C4042908 (UMLS CUI [1,2])
C0312634 (UMLS CUI [1,3])
Antiviral Therapy | Biological Response Modifier Therapy | Steroid therapy
Item
2. patient who was 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
Item
3. patient who was treated with lamivudine, lobucavir, famciclovir, 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])
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])
Ascites | Bleeding varices | Hepatic Encephalopathy
Item
4. patient who had 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 who was co-infected 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 of | Liver carcinoma Evidence of | Alpha-fetoprotein measurement | Ultrasonography
Item
6. patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-fetoprotein)evaluation was based on alpha-fetoprotein primarily. if alpha-fetoprotein level was suggestive of cirrhosis or hepatocellular carcinoma, confirmation was made with ultrasonography etc.
boolean
C0023890 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0201539 (UMLS CUI [3])
C0041618 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
7. patient who was 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 who was unwilling to use an "effective" method of contraception during treatment period and for up to 3 months after cessation of therapy. 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 supermicide 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 who had a clinically relevant history of abuse of alcohol or drugs.
boolean
C0038586 (UMLS CUI [1])
Gastrointestinal Diseases Significant | Kidney Diseases | Decompensated liver disease | Bronchopulmonary disease | nervous system disorder | Cardiovascular Diseases | Malignant Neoplasms | Hypersensitivity
Item
10. patient who had 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 who had 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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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