Age
Item
1. male or female between the ages of 18 and 65 years
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C Genotype
Item
2. chronic hepatitis c virus (hcv) genotype 1 infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
3. hcv rna level >10,000 iu/ml
boolean
C1272251 (UMLS CUI [1])
Hepatitis C, Chronic
Item
4. chronic hcv infection, defined as:
boolean
C0524910 (UMLS CUI [1])
Serology positive Hepatitis C virus | Serology positive Hepatitis C Antibodies | Serology positive Hepatitis C virus RNA
Item
previous documentation of positive hcv serology (hcv antibody or rna) at least 6 months (24 weeks) previously, or
boolean
C0242089 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0166049 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0369335 (UMLS CUI [3,2])
Serology positive Hepatitis C virus | Serology positive Hepatitis C Antibodies | Serology positive Hepatitis C virus RNA | Risk factor Previous Hepatitis C virus
Item
positive hcv serology (hcv antibody or rna) with a prior remote (more than 6 months previously) risk factor for acquisition of hcv or
boolean
C0242089 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0166049 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0369335 (UMLS CUI [3,2])
C0035648 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C0220847 (UMLS CUI [4,3])
Biopsy Consistent with Chronic Hepatitis C
Item
historical biopsy consistent with chronic hcv infection
boolean
C0005558 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
Abnormality Absent Hematology | Abnormality Absent Blood coagulation | Abnormality Absent Chemical procedure
Item
5. no clinically significant abnormalities in hematology, coagulation, or chemistry variables:
boolean
C1704258 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0200627 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0005778 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0201682 (UMLS CUI [3,3])
Hemoglobin measurement | Gender
Item
hemoglobin >12 g/dl for women; >13 g/dl for men
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
White Blood Cell Count procedure | Absolute neutrophil count
Item
total white cell count >3000/mm3 and absolute neutrophil count >1500/mm3
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
Platelet Count measurement
Item
platelets >100,000/mm3
boolean
C0032181 (UMLS CUI [1])
Prothrombin time assay | International Normalized Ratio
Item
prothrombin time (pt) and/or international normalized ratio (inr) less than or equal to 1.2 times the local upper limit of normal (uln)
boolean
C0033707 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Serum conjugated bilirubin measurement
Item
conjugated (direct) bilirubin less than or equal to 1.5 times the uln
boolean
C1278038 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine within normal limits
boolean
C0201976 (UMLS CUI [1])
Thyroid stimulating hormone measurement | T4 free measurement
Item
thyroid-stimulating hormone (tsh) and free thyroxine (t4) within normal limits
boolean
C0202230 (UMLS CUI [1])
C0202225 (UMLS CUI [2])
Gender Urine pregnancy test negative
Item
6. female patients: negative urine pregnancy test
boolean
C0079399 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Informed Consent
Item
7. ability to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Prior interferon therapy Chronic Hepatitis C
Item
1. previous interferon-based antiviral therapy for chronic hcv infection
boolean
C0278953 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
Pharmaceutical Preparations immunogenic
Item
2. previous treatment with known immunogenic drugs
boolean
C0013227 (UMLS CUI [1,1])
C0872192 (UMLS CUI [1,2])
Human immunodeficiency virus (HIV) coinfection | HBV coinfection
Item
3. concomitant human immunodeficiency (hiv) or hepatitis b virus (hbv) infection
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Liver disease Independent of Chronic Hepatitis C | Autoimmune liver disease | Alcoholic Liver Diseases
Item
4. cause of liver disease other than chronic hcv infection, such as autoimmune or alcoholic liver disease
boolean
C0023895 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C0400936 (UMLS CUI [2])
C0023896 (UMLS CUI [3])
End Stage Liver Disease | Encephalopathy | Bleeding esophageal varices | Bleeding gastric varices
Item
5. decompensated clinical liver disease, including a history of encephalopathy, bleeding esophageal or gastric varices, or ascites
boolean
C0745744 (UMLS CUI [1])
C0085584 (UMLS CUI [2])
C0155789 (UMLS CUI [3])
C0267209 (UMLS CUI [4])
Liver transplant recipient | Solid Organ Transplantation Recipient
Item
6. recipient of liver or other solid-organ transplantation
boolean
C3811922 (UMLS CUI [1])
C4331301 (UMLS CUI [2])
Hemorrhage Clinical Significance | Gross hematuria | Hemoptysis | Gastrointestinal Hemorrhage
Item
7. evidence of clinically significant bleeding, defined as gross hematuria, hemoptysis, or gastrointestinal bleeding
boolean
C0019080 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0473237 (UMLS CUI [2])
C0019079 (UMLS CUI [3])
C0017181 (UMLS CUI [4])
Bleeding tendency | Blood Coagulation Disorder | von Willebrand Disease | Hemophilia
Item
8. history of bleeding diathesis or coagulopathy (eg, von willebrand disease or hemophilia)
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0042974 (UMLS CUI [3])
C0684275 (UMLS CUI [4])
Thromboembolism | Deep Vein Thrombosis | Pulmonary Embolism
Item
9. history of thromboembolic events (eg, deep-vein thrombosis [dvt] or pulmonary embolism). previous central venous catheter-related thrombosis is acceptable if there is resolution recorded at least 12 months before enrollment.
boolean
C0040038 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
Oral anticoagulants | Anticoagulants Parenteral | Hormones Oral | Hormones Parenteral | Contraceptive Agents Containing Estrogens | Hormone replacement therapy | Estrogen Antagonists | Progestins
Item
10. requirement for concurrent treatment with oral or parenteral anticoagulants or hormones (estrogen-containing contraceptives, hormone replacement, antiestrogen agents, progestins)
boolean
C0354604 (UMLS CUI [1])
C0003280 (UMLS CUI [2,1])
C1518896 (UMLS CUI [2,2])
C0019932 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0019932 (UMLS CUI [4,1])
C1518896 (UMLS CUI [4,2])
C0009871 (UMLS CUI [5,1])
C0332256 (UMLS CUI [5,2])
C0014939 (UMLS CUI [5,3])
C0282402 (UMLS CUI [6])
C0014930 (UMLS CUI [7])
C0033306 (UMLS CUI [8])
Condition Treatment required Daily | Antiplatelet Agents | Thienopyridines | Dipyridamole | cilostazol | Adrenal Cortex Hormones
Item
11. condition requiring daily therapy with antiplatelet agents (eg, thienopyridines, dipyridamole, cilostazol; cardiovascular prophylaxis with aspirin is allowed) or corticosteroids
boolean
C0348080 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0085826 (UMLS CUI [2])
C2936588 (UMLS CUI [3])
C0012582 (UMLS CUI [4])
C0055729 (UMLS CUI [5])
C0001617 (UMLS CUI [6])
Therapy, Investigational
Item
12. investigational therapy within 28 days before the first planned dose of study drug
boolean
C0949266 (UMLS CUI [1])
Major surgery
Item
13. major surgery within 28 days before the first planned dose of study drug
boolean
C0679637 (UMLS CUI [1])
Comorbidity Uncontrolled | Diabetic - poor control | Uncontrolled hypertension | Thyroid Disease Uncontrolled
Item
14. uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease)
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0421258 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
C0040128 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Angina Pectoris | Symptoms Coronary Artery Disease | Cerebrovascular accident | Transient Ischemic Attack
Item
15. ongoing angina pectoris or other symptoms of coronary artery disease (cad); history of stroke, or transient ischemic attack (tia)
boolean
C0002962 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C1956346 (UMLS CUI [2,2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
Feeling suicidal | Suicide attempt
Item
16. history of suicidal ideation or attempt
boolean
C0424000 (UMLS CUI [1])
C0038663 (UMLS CUI [2])
Condition Requirement Coumarins
Item
17. condition requiring treatment (past or current) with coumarin-type agents
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0010207 (UMLS CUI [1,3])
Cardiac Arrhythmia Treatment required for
Item
18. cardiac arrhythmia requiring medical therapy
boolean
C0003811 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Non healing wound Serious | Wound healing status: secondary intention | Ulcer | Fracture
Item
19. serious nonhealing wound (including wound healing by secondary intention, ulcer, or bone fracture)
boolean
C0750433 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0518863 (UMLS CUI [2])
C0041582 (UMLS CUI [3])
C0016658 (UMLS CUI [4])
Malignant Neoplasms | Autoimmune Disease | Disease Causing Alteration in immune functioning | Therapy Causing Alteration in immune functioning
Item
20. cancer, autoimmune disease, or any disease or concurrent therapy known to cause significant alteration in immune function (corticosteroids are allowed before study enrollment and during the study to treat an ae)
boolean
C0006826 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C4061464 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C4061464 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Gender Contraceptive methods Unable | Gender Contraceptive methods Unwilling | Partner Contraceptive methods Unable | Partner Contraceptive methods Unwilling
Item
21. female patients and female partners of male patients: pregnancy, lactation, or inability/unwillingness to practice effective contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
C0682323 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
C0682323 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])