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])