Adult | Informed Consent | Protocol Compliance
Item
1. male or female patients of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
boolean
C0001675 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0525058 (UMLS CUI [3])
Hepatitis C Genotype | Therapy non-responder PEGINTERFERON/RIBAVIRIN
Item
2. hcv genotype 1 infected null responders to prior therapy comprised of pegylated interferon and ribavirin (standard of care, soc) defined as:
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0919875 (UMLS CUI [2,1])
C1875630 (UMLS CUI [2,2])
Virologic Response Early failed | Decrease;Hepatitis C virus RNA Week Number
Item
failure to achieve an early virologic response (< 2 log decline in hcv-rna by week 12), or
boolean
C4053862 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0547047 (UMLS CUI [2,1])
C0369335 (UMLS CUI [2,2])
C0439230 (UMLS CUI [2,3])
C0237753 (UMLS CUI [2,4])
Week Number Hepatitis C virus RNA failed | Hepatitis C virus RNA Response | Status post Week Number
Item
if week 12 hcv-rna was not obtained, post week 12 hcv-rna response was < 2 log decline
boolean
C0439230 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0369335 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0369335 (UMLS CUI [2,1])
C4053862 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0439230 (UMLS CUI [3,2])
C0237753 (UMLS CUI [3,3])
Hepatitis C virus RNA assay
Item
3. screening hcv-rna viral load of > 5.0 log (i.e., >100,000 iu/ml)
boolean
C1272251 (UMLS CUI [1])
Alpha-fetoprotein measurement
Item
4. alpha-fetoprotein (afp) less than or equal to 100 ng/ml
boolean
C0201539 (UMLS CUI [1])
Hemoglobin measurement | Gender | Hemoglobin A1c measurement | Platelet Count measurement | White Blood Cell Count procedure
Item
5. hemoglobin greater than or equal to 12 g/dl for women and greater than or equal to 13 g/dl for men, hemoglobin a1c less than or equal to 7.5 %, platelet count greater than or equal to 90 x 10^9/l, and white blood cell count greater than or equal to 1.5 x 10^9/l
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0023508 (UMLS CUI [5])
Serum TSH level normal
Item
6. thyroid stimulating hormone (tsh) within normal limits
boolean
C0580433 (UMLS CUI [1])
PEGINTERFERON/RIBAVIRIN Dose Percentage | Dose Size Percentage | Duration of treatment Percentage
Item
7. in the opinion of the principal investigator, the patient met the 80%/80%/80% rule during the previous pegylated interferon and ribavirin therapy (i.e., received at least 80% of the pegylated interferon and ribavirin doses, at least 80% of the dose size, for at least 80% of the treatment duration)
boolean
C1875630 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0178602 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0444921 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Females & males of reproductive potential Contraceptive methods Quantity
Item
8. willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to at least six months after the completion of the study.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Decrease Hepatitis C virus RNA Week Number | Decrease Hepatitis C virus RNA Timepoint
Item
1. < 2 log decline in hcv-rna at week 12 but > 2 log decline at any time from week 12 to week 24 during prior therapy with pegylated interferon and ribavirin (prior standard of care therapy)
boolean
C0547047 (UMLS CUI [1,1])
C0369335 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
C0547047 (UMLS CUI [2,1])
C0369335 (UMLS CUI [2,2])
C2348792 (UMLS CUI [2,3])
End Stage Liver Disease | Liver disease Severe
Item
2. decompensated or severe liver disease defined by one or more of the following criteria:
boolean
C0745744 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Prothrombin time assay | INR
Item
prothrombin time 4 seconds > control or inr (international normalized ratio) > 1.2
boolean
C0033707 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Serum total bilirubin measurement | Bilirubin, direct measurement
Item
total bilirubin ≥ 1.5 mg/dl or direct bilirubin ≥ 1 mg/dl
boolean
C1278039 (UMLS CUI [1])
C0201916 (UMLS CUI [2])
Serum albumin level decreased below normal
Item
serum albumin below normal limits
boolean
C3665623 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
aspartate aminotransferase (ast) or alanine aminotransferase (alt)> 5 x upper limit of normal (uln) at screening
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Ascites
Item
presence of ascites
boolean
C0003962 (UMLS CUI [1])
Hepatic Encephalopathy
Item
3. hepatic encephalopathy
boolean
C0019151 (UMLS CUI [1])
Liver carcinoma Clinical examination | Suspicion Liver carcinoma Clinical examination | Liver carcinoma Ultrasonography | Suspicion Liver carcinoma Ultrasonography | Liver carcinoma Imaging Technique | Suspicion Liver carcinoma Imaging Technique
Item
4. hepatocellular carcinoma (hcc) or suspicion of hcc clinically or on ultrasound (or other imaging techniques)
boolean
C2239176 (UMLS CUI [1,1])
C1456356 (UMLS CUI [1,2])
C0242114 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C1456356 (UMLS CUI [2,3])
C2239176 (UMLS CUI [3,1])
C0041618 (UMLS CUI [3,2])
C0242114 (UMLS CUI [4,1])
C2239176 (UMLS CUI [4,2])
C0041618 (UMLS CUI [4,3])
C2239176 (UMLS CUI [5,1])
C0079595 (UMLS CUI [5,2])
C0242114 (UMLS CUI [6,1])
C2239176 (UMLS CUI [6,2])
C0079595 (UMLS CUI [6,3])
Signs and Symptoms Eye Clinical Significance | Retinal Disease | Cotton wool spots | Disorder of the optic nerve | Retinal Hemorrhage | Abnormality of the eye
Item
5. clinically significant ocular findings such as retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or other abnormality
boolean
C0037088 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0035309 (UMLS CUI [2])
C0271053 (UMLS CUI [3])
C0029132 (UMLS CUI [4])
C0035317 (UMLS CUI [5])
C4316870 (UMLS CUI [6])
HIV Infection
Item
6. known history or presence of human immunodeficiency virus (hiv) infection
boolean
C0019693 (UMLS CUI [1])
HBV coinfection
Item
7. co-infection with hepatitis b virus (hbv)
boolean
C2242656 (UMLS CUI [1])
Pregnancy | Breast Feeding | Serum pregnancy test positive | Urine pregnancy test positive
Item
8. if female: pregnant, lactating, or positive serum or urine pregnancy test
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430063 (UMLS CUI [3])
C0430059 (UMLS CUI [4])
Partner Gender Pregnancy
Item
9. male partners of women who are currently pregnant
boolean
C0682323 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Renal Insufficiency | Serum creatinine raised | Creatinine clearance measurement | Hepatorenal Syndrome with Ascites
Item
10. renal impairment (creatinine > 1.2 x uln), serum creatinine clearance < 50 ml/min, or hepatorenal syndrome with ascites
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C0019212 (UMLS CUI [4,1])
C0332287 (UMLS CUI [4,2])
C0003962 (UMLS CUI [4,3])
Hospitalization Due to Liver disease
Item
11. hospitalization for liver disease within 60 days of screening
boolean
C0019993 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
Alcohol abuse | Alcohol consumption U/day
Item
12. history of alcohol abuse (> 50 g per day) within the past year
boolean
C0085762 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Mental Disorders, Severe | Depressive disorder
Item
13. history of severe psychiatric disease, especially depression, characterized by:
boolean
C4046029 (UMLS CUI [1])
C0011581 (UMLS CUI [2])
Suicide attempt
Item
suicide attempt
boolean
C0038663 (UMLS CUI [1])
Hospitalization Due to Mental disorders
Item
hospitalization for psychiatric disease
boolean
C0019993 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
Disability Due to Mental disorder
Item
period of disability as a result of psychiatric disease
boolean
C0231170 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
Exposure to CTS-1027
Item
14. prior exposure to cts-1027
boolean
C0332157 (UMLS CUI [1,1])
C4534678 (UMLS CUI [1,2])
Therapy non-responder | Therapy Except PEGINTERFERON/RIBAVIRIN
Item
15. patients who qualify as a null-responder based on treatment(s) other than pegylated interferon and ribavirin
boolean
C0919875 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C1875630 (UMLS CUI [2,3])
Cardiac Arrhythmia | Prolonged QTc interval
Item
16. history or presence of clinically concerning cardiac arrhythmias or prolongation of pre-dose corrected q-t interval (qtc) of > 450 milliseconds
boolean
C0003811 (UMLS CUI [1])
C1560305 (UMLS CUI [2])
Autoimmune Disease
Item
17. history of or current autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Fibromyalgia | Symptoms Suggestive of Fibromyalgia
Item
18. diagnosis of or symptoms suggestive of fibromyalgia
boolean
C0016053 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C0016053 (UMLS CUI [2,3])
Patient on waiting list Transplantation of liver | Recipient Organ transplant
Item
19. currently on liver transplantation waiting list or recipient of any organ transplant
boolean
C0422768 (UMLS CUI [1,1])
C0023911 (UMLS CUI [1,2])
C1709854 (UMLS CUI [2,1])
C0524930 (UMLS CUI [2,2])
Comorbidity Limiting Life Expectancy | Condition Limiting Life Expectancy | Congestive heart failure Moderate | Congestive heart failure Severe | Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Malignant Neoplasm Treated | Exception Malignant Neoplasm In complete remission
Item
20. other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure) or any malignancy other than curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years
boolean
C0009488 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0023671 (UMLS CUI [2,3])
C0018802 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0006826 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C1273390 (UMLS CUI [6,2])
C0007117 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C1273390 (UMLS CUI [7,2])
C0553723 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0006826 (UMLS CUI [8,2])
C1522326 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C0006826 (UMLS CUI [9,2])
C0677874 (UMLS CUI [9,3])
Exposure to Investigational Therapy | Disease Associated with Hepatitis C virus
Item
21. exposure to any other investigational treatment for any aspect of disease associated with hcv during the past 6 months
boolean
C0332157 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
Exposure to Investigational New Drugs | Exposure to Investigational Medical Device | Investigational New Drugs Scheduled | Investigational Medical Device Scheduled
Item
22. exposure to any investigational drug or device within 30 days of dosing, or scheduled receipt of another investigational drug or device during the course of this study.
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C2346570 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C2346570 (UMLS CUI [4,1])
C0205539 (UMLS CUI [4,2])