Age | Hepatitis C, Chronic
Item
age ≥18 years with chronic hcv infection
boolean
C0001779 (UMLS CUI [1])
C0524910 (UMLS CUI [2])
Liver Cirrhosis Absent Biopsy of liver | Noninvasive procedure allowed
Item
liver biopsy results ≤ 3 years prior to screening indicating the absence of cirrhosis. alternatively, a non-invasive procedure conducted within 6 months of screening is permitted in countries where allowed
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0814177 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Hepatitis C Genotype
Item
monoinfection with hcv genotype (gt) 1a or 1b
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
hcv rna ≥ 104 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Course Peginterferon alfa-2a | Course Peginterferon alfa-2b | Course Ribavirin
Item
prior treatment and adherence with one course of pegylated interferon alfa and rbv
boolean
C0750729 (UMLS CUI [1,1])
C0391001 (UMLS CUI [1,2])
C0750729 (UMLS CUI [2,1])
C0796545 (UMLS CUI [2,2])
C0750729 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
Medical Records | peginterferon alfa-2a | peginterferon alfa-2b | Ribavirin | Antiviral Response | Therapy non-responder | Partial responder to therapy | Viral Breakthrough | Relapse
Item
the subject's medical records must include sufficient detail of prior treatment with pegylated interferon alfa and rbv (start/stop dates and viral response) to allow for categorization of prior response as either null, partial, breakthrough or relapse.
boolean
C0025102 (UMLS CUI [1])
C0391001 (UMLS CUI [2])
C0796545 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
C1155328 (UMLS CUI [5])
C0919875 (UMLS CUI [6])
C1740822 (UMLS CUI [7])
C4053869 (UMLS CUI [8])
C0035020 (UMLS CUI [9])
Body mass index
Item
body mass index (bmi) 18-40 kg/m2 inclusive
boolean
C1305855 (UMLS CUI [1])
ECG normal | QTc interval QTcF - Fridericia's Correction Formula | Gender
Item
screening ecg without clinically significant abnormalities and with qtcf interval (qt corrected using fridericia's formula)
boolean
C0522054 (UMLS CUI [1])
C0489625 (UMLS CUI [2,1])
C1882513 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3])
ID.9
Item
≤ 450 msec for males and ≤ 470 msec for females.
boolean
Contraceptive methods Quantity | Childbearing Potential Pregnancy test negative
Item
agree to use two forms of highly effective contraception for the duration of the study and for 7 months after the last dose of study medication. females of childbearing potential must have a negative pregnancy test at screening and baseline.
boolean
C0700589 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
Peginterferon alfa-2a Discontinued | Peginterferon alfa-2b Discontinued | Ribavirin Discontinued | Cause Adverse event | Cause Toxicity | Patient unavailable Follow-up
Item
discontinuation of prior treatment with pegylated interferon alfa and rbv due to an adverse event, toxicity reasons or were lost to follow-up
boolean
C0391001 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0796545 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0035525 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0877248 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C0600688 (UMLS CUI [5,2])
C1301818 (UMLS CUI [6,1])
C3274571 (UMLS CUI [6,2])
Heart Disease
Item
history of significant cardiac disease
boolean
C0018799 (UMLS CUI [1])
Laboratory Results Above threshold | Leukopenia Above threshold | Neutropenia Above threshold | Anemia Above threshold | Thrombocytopenia Above threshold | Thyroid stimulating hormone Above threshold
Item
exceed criteria delineated in section 4.2 for laboratory measure thresholds related to leukopenia, neutropenia, anemia, thrombocytopenia, and thyroid stimulating hormone (tsh).
boolean
C1254595 (UMLS CUI [1,1])
C0443129 (UMLS CUI [1,2])
C0023530 (UMLS CUI [2,1])
C0443129 (UMLS CUI [2,2])
C0027947 (UMLS CUI [3,1])
C0443129 (UMLS CUI [3,2])
C0002871 (UMLS CUI [4,1])
C0443129 (UMLS CUI [4,2])
C0040034 (UMLS CUI [5,1])
C0443129 (UMLS CUI [5,2])
C0040160 (UMLS CUI [6,1])
C0443129 (UMLS CUI [6,2])
Autoimmune Disease | Decompensated liver disease | Poorly controlled diabetes mellitus | Mental disorders | Severe chronic obstructive pulmonary disease | HIV | Hepatitis B Virus | Liver carcinoma | Cancer Other | Exception Skin carcinoma resolved | Hemoglobinopathy | Retinal Disease | Immunosuppression
Item
diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (copd), hiv, hepatitis b virus (hbv), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.
boolean
C0004364 (UMLS CUI [1])
C4075847 (UMLS CUI [2])
C0554876 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0730607 (UMLS CUI [5])
C0019682 (UMLS CUI [6])
C0019169 (UMLS CUI [7])
C2239176 (UMLS CUI [8])
C1707251 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0699893 (UMLS CUI [10,2])
C1514893 (UMLS CUI [10,3])
C0019045 (UMLS CUI [11])
C0035309 (UMLS CUI [12])
C4048329 (UMLS CUI [13])
Amphetamines | Cocaine | Opiates | Alcohol abuse | Methadone | Buprenorphine Stable allowed
Item
current abuse of amphetamines, cocaine, opiates, or alcohol. methadone use is not allowed, however stable buprenorphine maintenance treatment for ≥ 6 months is permitted.
boolean
C0002667 (UMLS CUI [1])
C0009170 (UMLS CUI [2])
C0376196 (UMLS CUI [3])
C0085762 (UMLS CUI [4])
C0025605 (UMLS CUI [5])
C0006405 (UMLS CUI [6,1])
C0205360 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])