ID

29667

Description

A Phase II Study to Determine the Safety and Efficacy of Interferon-gamma in Patients With Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT00753467

Link

https://clinicaltrials.gov/show/NCT00753467

Keywords

Versions (1)
  1. 4/10/18 4/10/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 10, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00753467

English

Eligibility Hepatitis B NCT00753467

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must fulfill all of the following criteria to be eligible for enrollment into the study:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. men or women age 18 to 75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. chronic hepatitis b infection based on a history of positive anti-hbsag and positive for hbv dna and with or without elevations in liver tests (test to be repeated on screening)
Description

Hepatitis B, Chronic | Hepatitis B antibody positive | Hbv DNA Test Positive | Increased liver function tests | Liver function tests normal

Data type

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0860013
UMLS CUI [3,1]
C1256114
UMLS CUI [3,2]
C1514241
UMLS CUI [4]
C0877359
UMLS CUI [5]
C0438235
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with any of the following will be excluded from randomization:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. presence of clinically evident cirrhosis including: ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of gi variceal bleeding
Description

Liver Cirrhosis | Ascites Requirement Diuretic therapy | Hepatic Encephalopathy | Therapeutic procedure Hepatic Encephalopathy | Bleeding varices gastrointestinal

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0948575
UMLS CUI [3]
C0019151
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0019151
UMLS CUI [5,1]
C0333106
UMLS CUI [5,2]
C0521362
2. platelet count < 50,000/mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
3. serum alt level > 10 times upper limit of normal
Description

Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
4. alpha-fetoprotein level ≥ 200 ng/ml or alpha-fetoprotein level between 50-200 ng/ml in association with liver ultrasound or other radiographic abnormality suspicious for hepatic neoplasm
Description

Alpha one fetoprotein measurement Ultrasonography of liver | Radiography Abnormality Suspicious Liver neoplasm

Data type

boolean

Alias
UMLS CUI [1,1]
C0201539
UMLS CUI [1,2]
C0412534
UMLS CUI [2,1]
C0034571
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0750493
UMLS CUI [2,4]
C0023903
5. serum creatinine level > 1.6 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
6. hematology outside of specified limits: neutrophil count <1000/mm3, hemoglobin <10 g/dl in males and <9 g/dl in females
Description

Hematology | Neutrophil count | Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0200627
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0079399
7. unstable or uncontrolled thyroid disease
Description

Thyroid Disease Unstable | Thyroid Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0040128
UMLS CUI [2,2]
C0205318
8. treatment with any interferon-α or nucleoside/tide analog within the previous 4 weeks
Description

Interferon Analog | Nucleoside Analogs | Nucleotide analog

Data type

boolean

Alias
UMLS CUI [1,1]
C3652465
UMLS CUI [1,2]
C0243071
UMLS CUI [2]
C1579410
UMLS CUI [3]
C0597107
9. presence of clinically significant cryoglobulinemia (e.g., skin rash, arthritis, or renal insufficiency due to cryoglobuliemia)
Description

Cryoglobulinemia | Exanthema Due to Cryoglobulinemia | Arthritis Due to Cryoglobulinemia | Renal Insufficiency Due to Cryoglobulinemia

Data type

boolean

Alias
UMLS CUI [1]
C0010403
UMLS CUI [2,1]
C0015230
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0010403
UMLS CUI [3,1]
C0003864
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0010403
UMLS CUI [4,1]
C1565489
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0010403
10. presence or history of autoimmune hepatitis, alpha-1 anti-trypsin deficiency, hemochromatosis, wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, or sclerosing cholangitis (mild-to-moderate steatosis is acceptable)
Description

Hepatitis, Autoimmune | alpha 1-Antitrypsin Deficiency | Hemochromatosis | Hepatolenticular Degeneration | Drug-Induced Liver Injury | Liver disease Toxin Induced | Alcoholic Liver Diseases | Primary biliary cirrhosis | Cholangitis, Sclerosing | Fatty Liver Mild Acceptable | Fatty Liver Moderate Acceptable

Data type

boolean

Alias
UMLS CUI [1]
C0241910
UMLS CUI [2]
C0221757
UMLS CUI [3]
C0018995
UMLS CUI [4]
C0019202
UMLS CUI [5]
C0860207
UMLS CUI [6,1]
C0023895
UMLS CUI [6,2]
C0040549
UMLS CUI [6,3]
C0205263
UMLS CUI [7]
C0023896
UMLS CUI [8]
C0008312
UMLS CUI [9]
C0008313
UMLS CUI [10,1]
C0015695
UMLS CUI [10,2]
C2945599
UMLS CUI [10,3]
C1879533
UMLS CUI [11,1]
C0015695
UMLS CUI [11,2]
C0205081
UMLS CUI [11,3]
C1879533
11. chronic hepatitis c infection
Description

Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524910
12. hepatits delta infection (hdv)
Description

Hepatitis D Infection

Data type

boolean

Alias
UMLS CUI [1]
C0011226
13. known history of hiv infection or positive hiv antibody test by western blot (test performed within 60 days of screening can be used to determine eligibility)
Description

HIV Infection | HIV Seropositivity Western Blot

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0019699
UMLS CUI [2,2]
C0949466
14. a disease known to cause significant alteration in immunologic function including hematological malignancy or autoimmune disorder (e.g. rheumatoid arthritis, systemic lupus erythematosis, autoimmune thyroid disease, leukemia, lymphoma, etc)
Description

Disease Causing Alteration Immune function | Hematologic Neoplasms | Autoimmune Disease | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Autoimmune thyroid disease | Leukemia | Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C1515926
UMLS CUI [1,4]
C1817756
UMLS CUI [2]
C0376545
UMLS CUI [3]
C0004364
UMLS CUI [4]
C0003873
UMLS CUI [5]
C0024141
UMLS CUI [6]
C0178468
UMLS CUI [7]
C0023418
UMLS CUI [8]
C0024299
15. concurrent therapy with immunosuppressive drugs or cytotoxic agents such as oral prednisone, cyclosporine, azathioprine, or chemotherapeutic agent(s) (e.g., cyclophosphamide, methotrexate, or cancer chemotherapy) or radiation therapy
Description

Immunosuppressive Agents | Cytotoxic agent | Prednisone Oral Product | Cyclosporine | Azathioprine | Chemotherapeutic agent | Cyclophosphamide | Methotrexate | Chemotherapy Regimen | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0304497
UMLS CUI [3]
C3216040
UMLS CUI [4]
C0010592
UMLS CUI [5]
C0004482
UMLS CUI [6]
C0729502
UMLS CUI [7]
C0010583
UMLS CUI [8]
C0025677
UMLS CUI [9]
C0392920
UMLS CUI [10]
C1522449
16. behavior that suggests a significant risk of poor compliance including, but not limited to:
Description

Behavior At risk Poor compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0037397
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0032646
1. illicit drug abuse within the past 3 years
Description

DRUG ABUSE ILLICIT

Data type

boolean

Alias
UMLS CUI [1]
C0743253
2. current or history of alcohol abuse within the past 2 years
Description

Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0085762
17. prior treatment with ifn-γ 1b
Description

Interferon gamma-1b

Data type

boolean

Alias
UMLS CUI [1]
C0021741
18. history of unstable or deteriorating cardiac disease, including but not limited to:
Description

Heart Disease Unstable | Heart Disease deteriorating

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0332271
1. myocardial infarction, coronary artery bypass surgery, or angioplasty within the past 6 months
Description

Myocardial Infarction | Coronary Artery Bypass Surgery | Angioplasty

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3]
C0162577
2. congestive heart failure requiring hospitalization within the past 6 months
Description

Congestive heart failure Requirement Hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0019993
3. uncontrolled arrhythmias
Description

Cardiac Arrhythmia Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205318
4. transient ischemic attacks (tias)
Description

Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0007787
5. any cardiac condition that, in the opinion of the site pi, might be significantly exacerbated by flu-like symptoms associated with the administration of ifn γ 1b
Description

Heart condition Exacerbated | Influenza-like symptoms Associated with Interferon gamma-1b

Data type

boolean

Alias
UMLS CUI [1,1]
C3842523
UMLS CUI [1,2]
C1444749
UMLS CUI [2,1]
C0392171
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0021741
19. preexisting (within last two years) or active psychiatric condition including severe depression, major psychoses, suicidal ideation or suicidal attempts
Description

Mental disorders Pre-existing | Mental disorders | Severe depression | Psychotic Disorders Major | Feeling suicidal | Suicide attempt

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0588008
UMLS CUI [4,1]
C0033975
UMLS CUI [4,2]
C0205164
UMLS CUI [5]
C0424000
UMLS CUI [6]
C0038663
20. history of (within last two years) or current neurologic or psychiatric disorder that, in the opinion of the site pi, might be exacerbated by flu-like symptoms associated with the administration of ifn γ 1b. in addition, patients with the following conditions should be excluded:
Description

Nervous system disorder Exacerbated | Mental disorders Exacerbated | Influenza-like symptoms Associated with Interferon gamma-1b

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C1444749
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1444749
UMLS CUI [3,1]
C0392171
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0021741
1. history of multiple sclerosis
Description

Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0026769
2. seizures within the past 2 years
Description

Seizures

Data type

boolean

Alias
UMLS CUI [1]
C0036572
21. severe or poorly controlled diabetes
Description

Diabetes Mellitus Severe | Poorly controlled diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0554876
22. pregnancy or lactation. females of childbearing potential are required to have a negative urine pregnancy test prior to treatment and must agree to practice abstinence or prevent pregnancy by at least a barrier method of birth control for the duration of the study
Description

Pregnancy | Breast Feeding | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Sexual Abstinence | Childbearing Potential Barrier Contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430057
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0036899
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0004764
23. hemoglobinopthies (e.g. thalassemia, sickle cell disease)
Description

Hemoglobinopathies | Thalassemia | Anemia, Sickle Cell

Data type

boolean

Alias
UMLS CUI [1]
C0019045
UMLS CUI [2]
C0039730
UMLS CUI [3]
C0002895
24. any serious or chronic disease that, in the opinion of the principal investigator (pi), may affect the assessment of safety or efficacy parameters. this includes, but is not limited to, patients with malignancy who are receiving chemotherapy, chronic obstructive pulmonary disease or asthma requiring maintenance oral steroids, or active kidney disease
Description

Disease Serious Affecting Safety Assessment | Disease Serious Affecting Effectiveness Assessment | Chronic disease Affecting Safety Assessment | Chronic disease Affecting Effectiveness Assessment | Chemotherapy Malignant Neoplasms | Chronic Obstructive Airway Disease | Asthma Requirement Steroids Oral | Kidney Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0036043
UMLS CUI [1,5]
C1516048
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C1280519
UMLS CUI [2,5]
C1516048
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0036043
UMLS CUI [3,4]
C1516048
UMLS CUI [4,1]
C0008679
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C1280519
UMLS CUI [4,4]
C1516048
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0006826
UMLS CUI [6]
C0024117
UMLS CUI [7,1]
C0004096
UMLS CUI [7,2]
C1514873
UMLS CUI [7,3]
C0038317
UMLS CUI [7,4]
C1527415
UMLS CUI [8]
C0022658
25. any condition which, in the opinion of the site pi, is likely to result in the death of the patient within the next year
Description

Condition Resulting in Patient Death

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0030705
UMLS CUI [1,4]
C0011065
26. patients who, in the opinion of the site pi, are not suitable candidates for enrollment or would not comply with the requirements of the study
Description

Study Subject Participation Status Inappropriate | Protocol Compliance Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0332268
27. patients who have had a liver transplant
Description

Transplantation of liver

Data type

boolean

Alias
UMLS CUI [1]
C0023911
28. patients who have adefovir mutations on baseline tests
Description

Adefovir Relationship Mutation

Data type

boolean

Alias
UMLS CUI [1,1]
C0050175
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0026882
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Similar models

Eligibility Hepatitis B NCT00753467

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
patients must fulfill all of the following criteria to be eligible for enrollment into the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age
Item
1. men or women age 18 to 75 years
boolean
C0001779 (UMLS CUI [1])
Hepatitis B, Chronic | Hepatitis B antibody positive | Hbv DNA Test Positive | Increased liver function tests | Liver function tests normal
Item
2. chronic hepatitis b infection based on a history of positive anti-hbsag and positive for hbv dna and with or without elevations in liver tests (test to be repeated on screening)
boolean
C0524909 (UMLS CUI [1])
C0860013 (UMLS CUI [2])
C1256114 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0877359 (UMLS CUI [4])
C0438235 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients with any of the following will be excluded from randomization:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Liver Cirrhosis | Ascites Requirement Diuretic therapy | Hepatic Encephalopathy | Therapeutic procedure Hepatic Encephalopathy | Bleeding varices gastrointestinal
Item
1. presence of clinically evident cirrhosis including: ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of gi variceal bleeding
boolean
C0023890 (UMLS CUI [1])
C0003962 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0948575 (UMLS CUI [2,3])
C0019151 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0019151 (UMLS CUI [4,2])
C0333106 (UMLS CUI [5,1])
C0521362 (UMLS CUI [5,2])
Platelet Count measurement
Item
2. platelet count < 50,000/mm3
boolean
C0032181 (UMLS CUI [1])
Alanine aminotransferase increased
Item
3. serum alt level > 10 times upper limit of normal
boolean
C0151905 (UMLS CUI [1])
Alpha one fetoprotein measurement Ultrasonography of liver | Radiography Abnormality Suspicious Liver neoplasm
Item
4. alpha-fetoprotein level ≥ 200 ng/ml or alpha-fetoprotein level between 50-200 ng/ml in association with liver ultrasound or other radiographic abnormality suspicious for hepatic neoplasm
boolean
C0201539 (UMLS CUI [1,1])
C0412534 (UMLS CUI [1,2])
C0034571 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0750493 (UMLS CUI [2,3])
C0023903 (UMLS CUI [2,4])
Creatinine measurement, serum
Item
5. serum creatinine level > 1.6 mg/dl
boolean
C0201976 (UMLS CUI [1])
Hematology | Neutrophil count | Hemoglobin measurement | Gender
Item
6. hematology outside of specified limits: neutrophil count <1000/mm3, hemoglobin <10 g/dl in males and <9 g/dl in females
boolean
C0200627 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
Thyroid Disease Unstable | Thyroid Disease Uncontrolled
Item
7. unstable or uncontrolled thyroid disease
boolean
C0040128 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0040128 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Interferon Analog | Nucleoside Analogs | Nucleotide analog
Item
8. treatment with any interferon-α or nucleoside/tide analog within the previous 4 weeks
boolean
C3652465 (UMLS CUI [1,1])
C0243071 (UMLS CUI [1,2])
C1579410 (UMLS CUI [2])
C0597107 (UMLS CUI [3])
Cryoglobulinemia | Exanthema Due to Cryoglobulinemia | Arthritis Due to Cryoglobulinemia | Renal Insufficiency Due to Cryoglobulinemia
Item
9. presence of clinically significant cryoglobulinemia (e.g., skin rash, arthritis, or renal insufficiency due to cryoglobuliemia)
boolean
C0010403 (UMLS CUI [1])
C0015230 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0010403 (UMLS CUI [2,3])
C0003864 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0010403 (UMLS CUI [3,3])
C1565489 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0010403 (UMLS CUI [4,3])
Hepatitis, Autoimmune | alpha 1-Antitrypsin Deficiency | Hemochromatosis | Hepatolenticular Degeneration | Drug-Induced Liver Injury | Liver disease Toxin Induced | Alcoholic Liver Diseases | Primary biliary cirrhosis | Cholangitis, Sclerosing | Fatty Liver Mild Acceptable | Fatty Liver Moderate Acceptable
Item
10. presence or history of autoimmune hepatitis, alpha-1 anti-trypsin deficiency, hemochromatosis, wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, or sclerosing cholangitis (mild-to-moderate steatosis is acceptable)
boolean
C0241910 (UMLS CUI [1])
C0221757 (UMLS CUI [2])
C0018995 (UMLS CUI [3])
C0019202 (UMLS CUI [4])
C0860207 (UMLS CUI [5])
C0023895 (UMLS CUI [6,1])
C0040549 (UMLS CUI [6,2])
C0205263 (UMLS CUI [6,3])
C0023896 (UMLS CUI [7])
C0008312 (UMLS CUI [8])
C0008313 (UMLS CUI [9])
C0015695 (UMLS CUI [10,1])
C2945599 (UMLS CUI [10,2])
C1879533 (UMLS CUI [10,3])
C0015695 (UMLS CUI [11,1])
C0205081 (UMLS CUI [11,2])
C1879533 (UMLS CUI [11,3])
Hepatitis C, Chronic
Item
11. chronic hepatitis c infection
boolean
C0524910 (UMLS CUI [1])
Hepatitis D Infection
Item
12. hepatits delta infection (hdv)
boolean
C0011226 (UMLS CUI [1])
HIV Infection | HIV Seropositivity Western Blot
Item
13. known history of hiv infection or positive hiv antibody test by western blot (test performed within 60 days of screening can be used to determine eligibility)
boolean
C0019693 (UMLS CUI [1])
C0019699 (UMLS CUI [2,1])
C0949466 (UMLS CUI [2,2])
Disease Causing Alteration Immune function | Hematologic Neoplasms | Autoimmune Disease | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Autoimmune thyroid disease | Leukemia | Lymphoma
Item
14. a disease known to cause significant alteration in immunologic function including hematological malignancy or autoimmune disorder (e.g. rheumatoid arthritis, systemic lupus erythematosis, autoimmune thyroid disease, leukemia, lymphoma, etc)
boolean
C0012634 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C1515926 (UMLS CUI [1,3])
C1817756 (UMLS CUI [1,4])
C0376545 (UMLS CUI [2])
C0004364 (UMLS CUI [3])
C0003873 (UMLS CUI [4])
C0024141 (UMLS CUI [5])
C0178468 (UMLS CUI [6])
C0023418 (UMLS CUI [7])
C0024299 (UMLS CUI [8])
Immunosuppressive Agents | Cytotoxic agent | Prednisone Oral Product | Cyclosporine | Azathioprine | Chemotherapeutic agent | Cyclophosphamide | Methotrexate | Chemotherapy Regimen | Therapeutic radiology procedure
Item
15. concurrent therapy with immunosuppressive drugs or cytotoxic agents such as oral prednisone, cyclosporine, azathioprine, or chemotherapeutic agent(s) (e.g., cyclophosphamide, methotrexate, or cancer chemotherapy) or radiation therapy
boolean
C0021081 (UMLS CUI [1])
C0304497 (UMLS CUI [2])
C3216040 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0004482 (UMLS CUI [5])
C0729502 (UMLS CUI [6])
C0010583 (UMLS CUI [7])
C0025677 (UMLS CUI [8])
C0392920 (UMLS CUI [9])
C1522449 (UMLS CUI [10])
Behavior At risk Poor compliance
Item
16. behavior that suggests a significant risk of poor compliance including, but not limited to:
boolean
C0037397 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0032646 (UMLS CUI [1,3])
DRUG ABUSE ILLICIT
Item
1. illicit drug abuse within the past 3 years
boolean
C0743253 (UMLS CUI [1])
Alcohol abuse
Item
2. current or history of alcohol abuse within the past 2 years
boolean
C0085762 (UMLS CUI [1])
Interferon gamma-1b
Item
17. prior treatment with ifn-γ 1b
boolean
C0021741 (UMLS CUI [1])
Heart Disease Unstable | Heart Disease deteriorating
Item
18. history of unstable or deteriorating cardiac disease, including but not limited to:
boolean
C0018799 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0332271 (UMLS CUI [2,2])
Myocardial Infarction | Coronary Artery Bypass Surgery | Angioplasty
Item
1. myocardial infarction, coronary artery bypass surgery, or angioplasty within the past 6 months
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C0162577 (UMLS CUI [3])
Congestive heart failure Requirement Hospitalization
Item
2. congestive heart failure requiring hospitalization within the past 6 months
boolean
C0018802 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
Cardiac Arrhythmia Uncontrolled
Item
3. uncontrolled arrhythmias
boolean
C0003811 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Transient Ischemic Attack
Item
4. transient ischemic attacks (tias)
boolean
C0007787 (UMLS CUI [1])
Heart condition Exacerbated | Influenza-like symptoms Associated with Interferon gamma-1b
Item
5. any cardiac condition that, in the opinion of the site pi, might be significantly exacerbated by flu-like symptoms associated with the administration of ifn γ 1b
boolean
C3842523 (UMLS CUI [1,1])
C1444749 (UMLS CUI [1,2])
C0392171 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0021741 (UMLS CUI [2,3])
Mental disorders Pre-existing | Mental disorders | Severe depression | Psychotic Disorders Major | Feeling suicidal | Suicide attempt
Item
19. preexisting (within last two years) or active psychiatric condition including severe depression, major psychoses, suicidal ideation or suicidal attempts
boolean
C0004936 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2])
C0588008 (UMLS CUI [3])
C0033975 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0424000 (UMLS CUI [5])
C0038663 (UMLS CUI [6])
Nervous system disorder Exacerbated | Mental disorders Exacerbated | Influenza-like symptoms Associated with Interferon gamma-1b
Item
20. history of (within last two years) or current neurologic or psychiatric disorder that, in the opinion of the site pi, might be exacerbated by flu-like symptoms associated with the administration of ifn γ 1b. in addition, patients with the following conditions should be excluded:
boolean
C0027765 (UMLS CUI [1,1])
C1444749 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C1444749 (UMLS CUI [2,2])
C0392171 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0021741 (UMLS CUI [3,3])
Multiple Sclerosis
Item
1. history of multiple sclerosis
boolean
C0026769 (UMLS CUI [1])
Seizures
Item
2. seizures within the past 2 years
boolean
C0036572 (UMLS CUI [1])
Diabetes Mellitus Severe | Poorly controlled diabetes mellitus
Item
21. severe or poorly controlled diabetes
boolean
C0011849 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0554876 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Sexual Abstinence | Childbearing Potential Barrier Contraception
Item
22. pregnancy or lactation. females of childbearing potential are required to have a negative urine pregnancy test prior to treatment and must agree to practice abstinence or prevent pregnancy by at least a barrier method of birth control for the duration of the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430057 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0004764 (UMLS CUI [5,2])
Hemoglobinopathies | Thalassemia | Anemia, Sickle Cell
Item
23. hemoglobinopthies (e.g. thalassemia, sickle cell disease)
boolean
C0019045 (UMLS CUI [1])
C0039730 (UMLS CUI [2])
C0002895 (UMLS CUI [3])
Disease Serious Affecting Safety Assessment | Disease Serious Affecting Effectiveness Assessment | Chronic disease Affecting Safety Assessment | Chronic disease Affecting Effectiveness Assessment | Chemotherapy Malignant Neoplasms | Chronic Obstructive Airway Disease | Asthma Requirement Steroids Oral | Kidney Diseases
Item
24. any serious or chronic disease that, in the opinion of the principal investigator (pi), may affect the assessment of safety or efficacy parameters. this includes, but is not limited to, patients with malignancy who are receiving chemotherapy, chronic obstructive pulmonary disease or asthma requiring maintenance oral steroids, or active kidney disease
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0036043 (UMLS CUI [1,4])
C1516048 (UMLS CUI [1,5])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C1280519 (UMLS CUI [2,4])
C1516048 (UMLS CUI [2,5])
C0008679 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0036043 (UMLS CUI [3,3])
C1516048 (UMLS CUI [3,4])
C0008679 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C1280519 (UMLS CUI [4,3])
C1516048 (UMLS CUI [4,4])
C0392920 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C0024117 (UMLS CUI [6])
C0004096 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0038317 (UMLS CUI [7,3])
C1527415 (UMLS CUI [7,4])
C0022658 (UMLS CUI [8])
Condition Resulting in Patient Death
Item
25. any condition which, in the opinion of the site pi, is likely to result in the death of the patient within the next year
boolean
C0348080 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0011065 (UMLS CUI [1,4])
Study Subject Participation Status Inappropriate | Protocol Compliance Lacking
Item
26. patients who, in the opinion of the site pi, are not suitable candidates for enrollment or would not comply with the requirements of the study
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Transplantation of liver
Item
27. patients who have had a liver transplant
boolean
C0023911 (UMLS CUI [1])
Adefovir Relationship Mutation
Item
28. patients who have adefovir mutations on baseline tests
boolean
C0050175 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0026882 (UMLS CUI [1,3])
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