Protocol Compliance | Informed Consent
Item
1. willing to adhere to study requirements as evidenced by providing written informed consent before initiation of any study-related procedures
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Age
Item
2. aged between 18-65 years
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C Disease length
Item
3. documented history of chronic hcv infection (for at least 6 months prior to study entry) as diagnosed by either:
boolean
C0524910 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hepatitis C antibody positive
Item
1. anti-hcv positive or
boolean
C0281863 (UMLS CUI [1])
Hepatitis C RNA positive Polymerase Chain Reaction
Item
2. hcv rna viral load positive by pcr
boolean
C0855842 (UMLS CUI [1,1])
C0032520 (UMLS CUI [1,2])
Interferon therapy Unresponsive to Treatment | Patient Inappropriate Interferon therapy
Item
4. be a non-responder to or unsuitable for interferon based therapy.
boolean
C0279030 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0279030 (UMLS CUI [2,3])
Hepatitis | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
5. have liver inflammation, as defined by either ast and/or alt levels 2-10 x uln on at least 1 previous occasion within the past 6 months and at pre-treatment visit
boolean
C0019158 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Alpha-fetoprotein measurement
Item
6. alpha-fetoprotein (afp) less than/equal to 50µg/l
boolean
C0201539 (UMLS CUI [1])
Hemoglobin measurement | Platelet Count measurement | White Blood Cell Count procedure
Item
7. hemoglobin ≥100g/l, platelet count ≥75x109/l, and white blood cell count ≥1.5x109/l
boolean
C0518015 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
Gender | Childbearing Potential Absent | Childbearing Potential Contraceptive methods | Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Hormonal contraception | Barrier Contraception Double | Pregnancy test negative
Item
8. males, or females who are not of child-bearing potential or who are taking adequate contraceptive measures. female patients must be postmenopausal for at least 2 years prior to the study, surgically sterile, or using effective contraception for at least 2 months prior to starting study drug and until 28 days following the last dose of study drug. acceptable methods of birth control include hormonal contraceptives, or double-barrier methods.negative serum pregnancy test must be documented at the pre-treatment visit (i.e. within 14 days of starting study drug)
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4])
C0015787 (UMLS CUI [5])
C0079399 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C2985296 (UMLS CUI [7])
C0004764 (UMLS CUI [8,1])
C0205173 (UMLS CUI [8,2])
C0427780 (UMLS CUI [9])
Fibrosis stage Biopsy of liver | Liver Cirrhosis Excluded | Malignant Neoplasms Excluded | Minimal or absent scarring
Item
9. liver biopsy within past 3 years showing stage 2 fibrosis only (i.e. excludes cirrhosis and cancer); or within past 6 years showing stage 0 or 1 (no or minimal scarring).
boolean
C0016059 (UMLS CUI [1,1])
C0699749 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0023890 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
C1856942 (UMLS CUI [4])
Liver carcinoma | Suspicion Liver carcinoma | Liver carcinoma Ultrasonography | Suspicion Liver carcinoma Ultrasonography | Liver carcinoma Imaging Technique | Suspicion Liver carcinoma Imaging Technique
Item
1. hepatocellular carcinoma (hcc) or suspicion of hcc clinically or on ultrasound (or other imaging techniques)
boolean
C2239176 (UMLS CUI [1])
C0242114 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
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])
HIV Presence
Item
2. presence of human immunodeficiency virus (hiv)
boolean
C0019682 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
HBV coinfection
Item
3. co-infection with hepatitis b virus (hbv)
boolean
C2242656 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
4. last baseline ast and alt level prior to day 1 of <2.0xuln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Renal Insufficiency | Serum creatinine raised | Hepatorenal Syndrome
Item
5. renal impairment (creatinine>1.5 x uln) or hepatorenal syndrome
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
C0019212 (UMLS CUI [3])
Pancreatitis, Chronic
Item
6. chronic pancreatitis
boolean
C0149521 (UMLS CUI [1])
Hospitalization Liver disease
Item
7. hospitalization for liver disease within 60 days of the pre-treatment visit
boolean
C0019993 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
Liver transplant recipient
Item
8. liver transplant recipients
boolean
C3811922 (UMLS CUI [1])
Pharmacotherapy Hepatitis C
Item
9. use of drug therapy for hepatitis c, including the use of:
boolean
C0013216 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Pharmaceutical Preparations Activity Against Hepatitis C
Item
1. drugs with presumed anti-hepatitis c activity in the past 3 months
boolean
C0013227 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0521124 (UMLS CUI [1,3])
C0019196 (UMLS CUI [1,4])
Adrenal Cortex Hormones
Item
2. corticosteroids in the past 30 days
boolean
C0001617 (UMLS CUI [1])
Pharmaceutical Preparations Hepatotoxicity Risk Moderate | Pharmaceutical Preparations Hepatotoxicity High risk | Methyldopa | Valproic Acid | isoniazid | Nitrofurantoin
Item
3. drugs with medium to high risk of hepatotoxicity (including alpha methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin) in the past 30 days
boolean
C0013227 (UMLS CUI [1,1])
C0235378 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C0205081 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C0235378 (UMLS CUI [2,2])
C0332167 (UMLS CUI [2,3])
C0025741 (UMLS CUI [3])
C0042291 (UMLS CUI [4])
C0022209 (UMLS CUI [5])
C0028156 (UMLS CUI [6])
Amphetamines | Barbiturates | Meperidine | Benzodiazepines | Cocaine | Methadone | Opiates | Phencyclidine | Propoxyphene
Item
10. any patient who admits to using or has a positive screening test for: amphetamines, barbiturates, pethidine, benzodiazepine, cocaine, methadone, opiates, phencyclidine or propoxyphene (unless medically prescribed and in stable doses for at least 30 days)
boolean
C0002667 (UMLS CUI [1])
C0004745 (UMLS CUI [2])
C0025376 (UMLS CUI [3])
C0005064 (UMLS CUI [4])
C0009170 (UMLS CUI [5])
C0025605 (UMLS CUI [6])
C0376196 (UMLS CUI [7])
C0031381 (UMLS CUI [8])
C0033493 (UMLS CUI [9])
Alcohol consumption U/week
Item
11. alcohol consumption >5 units per week
boolean
C0001948 (UMLS CUI [1,1])
C0560588 (UMLS CUI [1,2])
Investigational New Drugs | Investigational Medical Device | Investigational New Drugs Scheduled | Investigational Medical Device Scheduled
Item
12. any patient who has received any investigational drug or device within 30 days of dosing, or who is scheduled to receive another investigational drug or device during the course of this trial
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C2346570 (UMLS CUI [4,1])
C0205539 (UMLS CUI [4,2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
13. history of a malignancy other than treated basal cell or squamous cell carcinoma of the skin; those with a history of malignancy that has been treated with no recurrence within the last 2 years are not excluded
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Antioxidants U/day | coenzyme Q10 | idebenone
Item
14. use of antioxidants (coenzyme q10 and idebenone) at doses ≥300mg/day within 120 days prior to enrolment. doses between 25-300mg/day are not an exclusion and require a 7 day washout prior to study enrolment
boolean
C0003402 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0056077 (UMLS CUI [2])
C0123163 (UMLS CUI [3])
Dietary Supplements Dose Constant | Vitamin supplement | Mineral supplements
Item
15. use of dietary supplements (vitamin or mineral) at constant doses throughout the study (unless medically prescribed). patients choosing to stop using supplements are not excluded and require a 7 day washout period prior to study enrolment
boolean
C0242295 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1948059 (UMLS CUI [1,3])
C0681579 (UMLS CUI [2])
C0556112 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs Component | Hypersensitivity Compound Similar | Hypersensitivity coenzyme Q10 | Hypersensitivity idebenone
Item
16. history of a hypersensitivity reaction to any components of the study drug or structurally similar compounds including coenzyme q10 and idebenone
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0056077 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0123163 (UMLS CUI [4,2])
Lacking Able to swallow Tablets
Item
17. unable to swallow tablets whole.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])