ID

17490

Beschreibung

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

Stichworte

  1. 18.09.16 18.09.16 -
Hochgeladen am

18. September 2016

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Hepatitis B NCT00313261

Eligibility Hepatitis B NCT00313261

Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Placebo given Clinical Trial l-fmau

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

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:
Beschreibung

Patient Visit Complete | Follow-up visit Additional

Datentyp

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
Beschreibung

Clevudine | HBV DNA decreased

Datentyp

boolean

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

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.
Beschreibung

Hepatitis B e Antigens Seroconversion Antibody to hepatitis Be antigen

Datentyp

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.
Beschreibung

Antiviral Therapy | Biological Response Modifier Therapy | Steroid therapy

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Ascites | Bleeding varices | Hepatic Encephalopathy

Datentyp

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.
Beschreibung

HCV coinfection | Coinfection HDV | HIV coinfection

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

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)
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 who had a clinically relevant history of abuse of alcohol or drugs.
Beschreibung

Substance Use Disorders

Datentyp

boolean

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

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

Datentyp

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:
Beschreibung

Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

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]
Beschreibung

Age | Body Weight | Creatinine measurement, serum | Gender

Datentyp

boolean

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

Ähnliche Modelle

Eligibility Hepatitis B NCT00313261

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])

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