ID

17509

Description

KRN7000 in Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT00363155

Link

https://clinicaltrials.gov/show/NCT00363155

Keywords

Versions (2)
  1. 9/20/16 9/20/16 -
  2. 9/20/16 9/20/16 -
Uploaded on

September 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT00363155

English

Eligibility Hepatitis B, Chronic NCT00363155

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis b (confirmed by a liver biopsy performed within 3 years prior to the screenings visit and hbv dna in serum >10e5 copies/ml at the screenings visit).
Description

Hepatitis B, Chronic | Biopsy of liver | Hepatitis B DNA Measurement

Data type

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0193388
UMLS CUI [3]
C3641250
alt > 1.2 x uln on two occasions documented within 8 weeks before initiation of treatment.
Description

Alanine aminotransferase measurement Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1265611
able and likely to attend regularly for treatment and follow-up.
Description

Therapeutic procedure Willing | Clinical Study Follow-up Adherence

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C1510802
written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
adequate contraception for males and females during treatment and follow-up (written confirmation).
Description

Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with evidence of cirrhosis.
Description

Liver Cirrhosis Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332120
decompensated liver disease, as marked by: bilirubin greater than 20 micromol/l or serum albumin <35 g/l or prothrombin time greater than 3 seconds prolonged or quick test below 70% or history of bleeding esophageal varices, ascites or hepatic encephalopathy.
Description

Decompensated liver disease | Serum total bilirubin measurement | Serum albumin measurement | Prothrombin time increased | Quick Test for Liver Function | Bleeding esophageal varices | Ascites | Hepatic Encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0523465
UMLS CUI [4]
C0151872
UMLS CUI [5]
C0086890
UMLS CUI [6]
C0155789
UMLS CUI [7]
C0003962
UMLS CUI [8]
C0019151
systemic ifn treatment, systemic antiviral agents, systemic corticosteroids, immune suppressive treatment or any investigational drug within 3 months of entry to this protocol.
Description

Interferon therapy Systemic | Antiviral Agents Systemic | systemic steroids | Therapeutic immunosuppression | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0279030
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0003451
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C2825233
UMLS CUI [4]
C0021079
UMLS CUI [5]
C0013230
patients with alt levels greater than 10 times uln will not be enrolled but may be followed until three consecutive determinations within 2 months are below this level.
Description

Alanine aminotransferase measurement Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1265611
pregnancy, or in women of child-bearing potential or in spouses of such women, inability to practice adequate contraception.
Description

Pregnancy | Childbearing Potential Contraceptive methods Inadequate | spouse Contraceptive methods Inadequate

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0205412
UMLS CUI [3,1]
C0162409
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0205412
significant systemic or major illnesses other than liver disease, including congestive heart failure, ischemic heart disease, angina pectoris, cerebrovascular disease, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease or depression, anaphylactic disorder.
Description

Systemic disease Significant | Illness Major | Liver diseases | Congestive heart failure | Myocardial Ischemia | Angina Pectoris | Cerebrovascular Disorders | Kidney Failure | Creatinine clearance measurement | Organ Transplantation | Mental disorders Serious | Depressive disorder | anaphylaxis

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205164
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0151744
UMLS CUI [6]
C0002962
UMLS CUI [7]
C0007820
UMLS CUI [8]
C0035078
UMLS CUI [9]
C0373595
UMLS CUI [10]
C0029216
UMLS CUI [11,1]
C0004936
UMLS CUI [11,2]
C0205404
UMLS CUI [12]
C0011581
UMLS CUI [13]
C0002792
pre-existing severe cytopenia; hb<7 mmol/l, wbc <3x10e9/l, plt <100x10e9/l, lymphocyte <0.5x10e9/l.
Description

Severe cytopenia Pre-existing | Hemoglobin | White Blood Cell Count procedure | Platelet Count measurement | Lymphocyte

Data type

boolean

Alias
UMLS CUI [1,1]
C1263979
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C0019046
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0024264
any history or presence of autoimmune disease.
Description

Autoimmune Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0004364
evidence of hepatocellular carcinoma; alpha-fetoprotein (afp) levels greater than 50 ng/ml and ultrasound (or other imaging study) within 6 months prior to the entry demonstrating a mass suggestive of liver cancer.
Description

Liver carcinoma Evidence of | Alpha fetoprotein measurement | Ultrasonography | imaging study | Mass Suggestive of Malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0201539
UMLS CUI [3]
C0041618
UMLS CUI [4]
C1881134
UMLS CUI [5,1]
C0577559
UMLS CUI [5,2]
C0332299
UMLS CUI [5,3]
C0345904
human immunodeficiency virus infection, as shown by presence of anti-hiv antibody.
Description

HIV Infections | HIV Antibody Measurement

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C3714540
patients with cerebroside metabolite abnormalities (e.g. gaucher's disease).
Description

Gaucher Disease

Data type

boolean

Alias
UMLS CUI [1]
C0017205
other acquired or inherited causes of liver disease: hepatitis c, hepatitis d, alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune liver disease, wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency.
Description

Liver disease Causations | Hepatitis C | Hepatitis D Infection | Alcoholic Liver Diseases | Liver diseases Obesity Induced | Drug-Induced Liver Injury | Autoimmune liver disease | Hepatolenticular Degeneration | Hemochromatosis | alpha 1-Antitrypsin Deficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0085978
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0011226
UMLS CUI [4]
C0023896
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0028754
UMLS CUI [5,3]
C0205263
UMLS CUI [6]
C0860207
UMLS CUI [7]
C0400936
UMLS CUI [8]
C0019202
UMLS CUI [9]
C0018995
UMLS CUI [10]
C0221757
any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study.
Description

Condition Patient Inappropriate | Condition Interferes with Study Subject Participation Status | Condition Interferes with Clinical Trial Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0008976
UMLS CUI [3,4]
C0205197
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Similar models

Eligibility Hepatitis B, Chronic NCT00363155

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B, Chronic | Biopsy of liver | Hepatitis B DNA Measurement
Item
chronic hepatitis b (confirmed by a liver biopsy performed within 3 years prior to the screenings visit and hbv dna in serum >10e5 copies/ml at the screenings visit).
boolean
C0524909 (UMLS CUI [1])
C0193388 (UMLS CUI [2])
C3641250 (UMLS CUI [3])
Alanine aminotransferase measurement Quantity
Item
alt > 1.2 x uln on two occasions documented within 8 weeks before initiation of treatment.
boolean
C0201836 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Therapeutic procedure Willing | Clinical Study Follow-up Adherence
Item
able and likely to attend regularly for treatment and follow-up.
boolean
C0087111 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C1510802 (UMLS CUI [2,2])
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Gender Contraceptive methods
Item
adequate contraception for males and females during treatment and follow-up (written confirmation).
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Liver Cirrhosis Evidence of
Item
patients with evidence of cirrhosis.
boolean
C0023890 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Decompensated liver disease | Serum total bilirubin measurement | Serum albumin measurement | Prothrombin time increased | Quick Test for Liver Function | Bleeding esophageal varices | Ascites | Hepatic Encephalopathy
Item
decompensated liver disease, as marked by: bilirubin greater than 20 micromol/l or serum albumin <35 g/l or prothrombin time greater than 3 seconds prolonged or quick test below 70% or history of bleeding esophageal varices, ascites or hepatic encephalopathy.
boolean
C4075847 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0523465 (UMLS CUI [3])
C0151872 (UMLS CUI [4])
C0086890 (UMLS CUI [5])
C0155789 (UMLS CUI [6])
C0003962 (UMLS CUI [7])
C0019151 (UMLS CUI [8])
Interferon therapy Systemic | Antiviral Agents Systemic | systemic steroids | Therapeutic immunosuppression | Investigational New Drugs
Item
systemic ifn treatment, systemic antiviral agents, systemic corticosteroids, immune suppressive treatment or any investigational drug within 3 months of entry to this protocol.
boolean
C0279030 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0003451 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C2825233 (UMLS CUI [3])
C0021079 (UMLS CUI [4])
C0013230 (UMLS CUI [5])
Alanine aminotransferase measurement Quantity
Item
patients with alt levels greater than 10 times uln will not be enrolled but may be followed until three consecutive determinations within 2 months are below this level.
boolean
C0201836 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Pregnancy | Childbearing Potential Contraceptive methods Inadequate | spouse Contraceptive methods Inadequate
Item
pregnancy, or in women of child-bearing potential or in spouses of such women, inability to practice adequate contraception.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
C0162409 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
Systemic disease Significant | Illness Major | Liver diseases | Congestive heart failure | Myocardial Ischemia | Angina Pectoris | Cerebrovascular Disorders | Kidney Failure | Creatinine clearance measurement | Organ Transplantation | Mental disorders Serious | Depressive disorder | anaphylaxis
Item
significant systemic or major illnesses other than liver disease, including congestive heart failure, ischemic heart disease, angina pectoris, cerebrovascular disease, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease or depression, anaphylactic disorder.
boolean
C0442893 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0151744 (UMLS CUI [5])
C0002962 (UMLS CUI [6])
C0007820 (UMLS CUI [7])
C0035078 (UMLS CUI [8])
C0373595 (UMLS CUI [9])
C0029216 (UMLS CUI [10])
C0004936 (UMLS CUI [11,1])
C0205404 (UMLS CUI [11,2])
C0011581 (UMLS CUI [12])
C0002792 (UMLS CUI [13])
Severe cytopenia Pre-existing | Hemoglobin | White Blood Cell Count procedure | Platelet Count measurement | Lymphocyte
Item
pre-existing severe cytopenia; hb<7 mmol/l, wbc <3x10e9/l, plt <100x10e9/l, lymphocyte <0.5x10e9/l.
boolean
C1263979 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0019046 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0024264 (UMLS CUI [5])
Autoimmune Diseases
Item
any history or presence of autoimmune disease.
boolean
C0004364 (UMLS CUI [1])
Liver carcinoma Evidence of | Alpha fetoprotein measurement | Ultrasonography | imaging study | Mass Suggestive of Malignant neoplasm of liver
Item
evidence of hepatocellular carcinoma; alpha-fetoprotein (afp) levels greater than 50 ng/ml and ultrasound (or other imaging study) within 6 months prior to the entry demonstrating a mass suggestive of liver cancer.
boolean
C2239176 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0201539 (UMLS CUI [2])
C0041618 (UMLS CUI [3])
C1881134 (UMLS CUI [4])
C0577559 (UMLS CUI [5,1])
C0332299 (UMLS CUI [5,2])
C0345904 (UMLS CUI [5,3])
HIV Infections | HIV Antibody Measurement
Item
human immunodeficiency virus infection, as shown by presence of anti-hiv antibody.
boolean
C0019693 (UMLS CUI [1])
C3714540 (UMLS CUI [2])
Gaucher Disease
Item
patients with cerebroside metabolite abnormalities (e.g. gaucher's disease).
boolean
C0017205 (UMLS CUI [1])
Liver disease Causations | Hepatitis C | Hepatitis D Infection | Alcoholic Liver Diseases | Liver diseases Obesity Induced | Drug-Induced Liver Injury | Autoimmune liver disease | Hepatolenticular Degeneration | Hemochromatosis | alpha 1-Antitrypsin Deficiency
Item
other acquired or inherited causes of liver disease: hepatitis c, hepatitis d, alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune liver disease, wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency.
boolean
C0023895 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2])
C0011226 (UMLS CUI [3])
C0023896 (UMLS CUI [4])
C0023895 (UMLS CUI [5,1])
C0028754 (UMLS CUI [5,2])
C0205263 (UMLS CUI [5,3])
C0860207 (UMLS CUI [6])
C0400936 (UMLS CUI [7])
C0019202 (UMLS CUI [8])
C0018995 (UMLS CUI [9])
C0221757 (UMLS CUI [10])
Condition Patient Inappropriate | Condition Interferes with Study Subject Participation Status | Condition Interferes with Clinical Trial Completion
Item
any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study.
boolean
C0348080 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
C0205197 (UMLS CUI [3,4])
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