Hepatitis C Genotype Subtype All | Other Coding | Combined Modality Therapy | sofosbuvir | Ribavirin | simeprevir
Item
1. hcv genotype 1 infection (all subtypes and q80k a type of mutation are allowed), and have been approved by a third party payer for the fda-approved combination of sofosbuvir (sof) plus ribavirin. the study drug, simeprevir (smv)
boolean
C0019196 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
C0449560 (UMLS CUI [1,3])
C0444868 (UMLS CUI [1,4])
C3846158 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C2976303 (UMLS CUI [4])
C0035525 (UMLS CUI [5])
C2605855 (UMLS CUI [6])
Liver Cirrhosis | Biopsy of liver | AST to platelet ratio index | FibroTest Score Measurement | Fibroscan | Result Liver Stiffness
Item
2. biopsy proven cirrhosis, or clinical cirrhosis with apri (ast to platelet ratio index to determine clinical cirrhosis)> 2, fibrotest > 0.75, or fibroscan > 12.5 results stiffness (kpa).
boolean
C0023890 (UMLS CUI [1])
C0193388 (UMLS CUI [2])
C4483916 (UMLS CUI [3])
C3642160 (UMLS CUI [4])
C4522043 (UMLS CUI [5])
C1274040 (UMLS CUI [6,1])
C4034374 (UMLS CUI [6,2])
MELD score
Item
3. meld 10 or less
boolean
C4048785 (UMLS CUI [1])
Life Expectancy | Transplantation of liver Absent
Item
4. expected survival without liver transplantation of >1 year
boolean
C0023671 (UMLS CUI [1])
C0023911 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Liver carcinoma | MELD score | Serial imaging | Tumor Diameter | Transplantation Anticipated
Item
5. patients with hepatocellular carcinoma (hcc) are included as long as disease meld is 10 or less, and anticipated time to transplant is >1 year. an example, might be a patient with a subcentimeter hcc who is undergoing serial imaging to document tumor growth to tumor diameter >2 cm prior to listing for transplantation (in order to secure meld exception). in this case, there could be a time lapse of 3 months or more while monitoring tumor growth, and a further time lapse of 9 months or more until the time of transplantation.
boolean
C2239176 (UMLS CUI [1])
C4048785 (UMLS CUI [2])
C0203640 (UMLS CUI [3])
C0027651 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C0040732 (UMLS CUI [5,1])
C3840775 (UMLS CUI [5,2])
TIPS | Portal vein thrombosis
Item
6. patients with tips or portal vein thrombosis may be included. -
boolean
C0339897 (UMLS CUI [1])
C0155773 (UMLS CUI [2])
Informed Consent Unable
Item
1. inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs | Adverse reactions Serious Investigational New Drugs
Item
2. known hypersensitivity or serious adverse reaction to any of the study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Age
Item
3. age <18 or >80 years
boolean
C0001779 (UMLS CUI [1])
Pregnancy Patient Self-Report | Pregnancy Urine dipstick test
Item
4. pregnancy as determined by subject reporting and urine dipstick testing at screening.
boolean
C0032961 (UMLS CUI [1,1])
C0681906 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C0430370 (UMLS CUI [2,2])
Chronic liver disease | Chronic nonalcoholic liver disease | Alcoholic Liver Diseases | Hepatitis B | Hemochromatosis | Autoimmune liver disease
Item
5. other underlying chronic liver disease - examples that would exclude a patient from participating include but are not limited to nonalcoholic liver disease, alcoholic liver disease, hepatitis b, hemochromatosis, and autoimmune liver disease.
boolean
C0341439 (UMLS CUI [1])
C0221388 (UMLS CUI [2])
C0023896 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C0018995 (UMLS CUI [5])
C0400936 (UMLS CUI [6])
Medical condition Serious | Cardiovascular Disease Unstable | Coronary Artery Disease Unstable | Lung disease Unstable | Heart Failure, Right-Sided | Left-Sided Heart Failure | Malignant Neoplasms | Exception Liver carcinoma | Communicable Disease Serious
Item
6. serious other underlying medical condition - examples include but are not limited to unstable cardiovascular, coronary, or pulmonary disease including right and left sided heart failure, active malignancy other than hcc, or serious infection.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C1956346 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0024115 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0235527 (UMLS CUI [5])
C0023212 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C2239176 (UMLS CUI [8,2])
C0009450 (UMLS CUI [9,1])
C0205404 (UMLS CUI [9,2])
Estimation of creatinine clearance by Cockcroft-Gault formula | Body Surface Area
Item
7. estimated creatinine clearance < 30 ml min-1 1.73 m2 surface area (bsa)
boolean
C2711451 (UMLS CUI [1])
C0005902 (UMLS CUI [2])
Hemoglobin measurement
Item
8. hemoglobin <10 g/dl
boolean
C0518015 (UMLS CUI [1])
Neutrophil count
Item
9. neutrophils <500 /μl
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
10. platelets <50,000 /μl
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
11. bilirubin >4 mg/dl
boolean
C1278039 (UMLS CUI [1])
Albumin measurement
Item
12. albumin < 2.8 g/dl
boolean
C0201838 (UMLS CUI [1])
Blood coagulation | International Normalized Ratio
Item
13. blood clotting: international normalised ratio (inr) > 2
boolean
C0005778 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
MELD score
Item
14. meld >10
boolean
C4048785 (UMLS CUI [1])
Child-Pugh-Turcotte score
Item
15. child-turcotte-pugh class b or c; or, ctp score >7
boolean
C3854424 (UMLS CUI [1])
Condition Affecting Absorption Cholate | Liver Function Tests | Intestinal resection Extensive | Gastroparesis due to diabetes mellitus | Ileal Diseases | Ileectomy
Item
16. conditions that would affect the absorption of orally administered cholate used in the hepquant® test - such as, extensive intestinal resection, diabetic gastroparesis, and ileal disease or resection.
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0109497 (UMLS CUI [1,4])
C0023901 (UMLS CUI [2])
C1096244 (UMLS CUI [3,1])
C0205231 (UMLS CUI [3,2])
C0267176 (UMLS CUI [4])
C0020875 (UMLS CUI [5])
C0399935 (UMLS CUI [6])
Adrenergic beta-Antagonists | Angiotensin-Converting Enzyme Inhibitors
Item
17. concomitant use of both beta-blocker and ace inhibitor
boolean
C0001645 (UMLS CUI [1])
C0003015 (UMLS CUI [2])
Pharmaceutical Preparations Drug Interactions Investigational New Drugs | sofosbuvir | simeprevir | Ribavirin | Pharmaceutical Preparations Discontinue Unsuccessful
Item
18. subjects taking any other medications with significant drug drug interactions related to the study medications (sofosbuvir, simeprevir, or ribavirin) who cannot discontinue or substitute that medication, will be excluded.
boolean
C0013227 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C2976303 (UMLS CUI [2])
C2605855 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C1272705 (UMLS CUI [5,3])