Age
Item
male or female, aged from 18 to 70 years old, inclusive
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C Disease length
Item
chronic hcv infection for at least 6 months prior to baseline
boolean
C0524910 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Liver Cirrhosis Absent Biopsy of liver
Item
subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis.
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
Hepatitis C Genotype
Item
monoinfection with hcv genotype 1
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
hcv rna > 10^4 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Course Pegasys | Course Pegintron | Course Ribavirin
Item
prior treatment and adherence (as defined by receiving at least 80% of the prescribed treatment) with one course of a pegylated interferon-alfa (pegasys or peg-intron) and rbv
boolean
C0750729 (UMLS CUI [1,1])
C1176430 (UMLS CUI [1,2])
C0750729 (UMLS CUI [2,1])
C1527737 (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
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
boolean
C0025102 (UMLS CUI [1])
C0391001 (UMLS CUI [2])
C0796545 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
C1155328 (UMLS CUI [5])
Therapy non-responder | Partial responder to therapy | Hepatitis C RNA Reduction
Item
non-responder: subject did not achieve undetectable hcv rna levels during or at the end of a treatment period of at least 12 weeks duration. within nonresponders, subjects will be further defined as null or partial responders if they had < 2 log10 or ≥ 2 log10 reduction, respectively, in hcv rna during the first 12 weeks of treatment
boolean
C0919875 (UMLS CUI [1])
C1740822 (UMLS CUI [2])
C0855840 (UMLS CUI [3,1])
C0392756 (UMLS CUI [3,2])
Therapy responder | Hepatitis C RNA Undetectable | Relapse | Hepatitis C RNA Detectable | Viral Breakthrough
Item
responder: subject achieved undetectable hcv rna during treatment. within responders, subjects will be further defined as relapsers if they had undetectable hcv rna at the end of at least 42 weeks of treatment but detectable hcv rna levels observed within 1 year of the end of treatment and breakthrough subjects if they achieved undetectable hcv rna levels during the treatment period but detectable hcv rna at the end of treatment.
boolean
C0919876 (UMLS CUI [1])
C0855840 (UMLS CUI [2,1])
C3827727 (UMLS CUI [2,2])
C0035020 (UMLS CUI [3])
C0855840 (UMLS CUI [4,1])
C3830527 (UMLS CUI [4,2])
C4053869 (UMLS CUI [5])
Antiviral Agents Oral Absent HCV | Exception Ribavirin
Item
no prior treatment with an oral hcv antiviral (exclusive of rbv).
boolean
C0003451 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0220847 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
Body mass index
Item
body mass index (bmi) 18-36 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) ≤ 450 msec for males and ≤ 470 msec for females
boolean
C0522054 (UMLS CUI [1])
C0489625 (UMLS CUI [2,1])
C1882513 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3])
Creatinine clearance measurement
Item
creatinine clearance ≥ 50 ml/min.
boolean
C0373595 (UMLS CUI [1])
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 6 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
discontinued 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])
Leukopenia Above threshold | Neutropenia Above threshold | Anemia Above threshold | Thrombocytopenia Above threshold | Thyroid stimulating hormone Above threshold
Item
exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (tsh)
boolean
C0023530 (UMLS CUI [1,1])
C0443129 (UMLS CUI [1,2])
C0027947 (UMLS CUI [2,1])
C0443129 (UMLS CUI [2,2])
C0002871 (UMLS CUI [3,1])
C0443129 (UMLS CUI [3,2])
C0040034 (UMLS CUI [4,1])
C0443129 (UMLS CUI [4,2])
C0040160 (UMLS CUI [5,1])
C0443129 (UMLS CUI [5,2])
Autoimmune Disease | Decompensated liver disease | Poorly controlled diabetes mellitus | Mental disorders | Severe chronic obstructive pulmonary disease | HIV | Hepatitis B Virus | Hepatitis C virus genotype | Liver carcinoma | Cancer Other | Exception Skin carcinoma | Hemoglobinopathy | Retinal Diseases | 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), or another hcv genotype, hepatocellular carcinoma or other malignancy (with exception of certain 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])
C1148363 (UMLS CUI [8])
C2239176 (UMLS CUI [9])
C1707251 (UMLS CUI [10])
C1705847 (UMLS CUI [11,1])
C0699893 (UMLS CUI [11,2])
C0019045 (UMLS CUI [12])
C0035309 (UMLS CUI [13])
C4048329 (UMLS CUI [14])
Amphetamines | Cocaine | Opiates | Morphine | Heroin | Alcohol abuse | Methadone Stable | Buprenorphine Stable allowed
Item
current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. subjects on stable methadone are excluded, however stable buprenorphine maintenance treatment for at least 6 months is not exclusionary
boolean
C0002667 (UMLS CUI [1])
C0009170 (UMLS CUI [2])
C0376196 (UMLS CUI [3])
C0026549 (UMLS CUI [4])
C0011892 (UMLS CUI [5])
C0085762 (UMLS CUI [6])
C0025605 (UMLS CUI [7,1])
C0205360 (UMLS CUI [7,2])
C0006405 (UMLS CUI [8,1])
C0205360 (UMLS CUI [8,2])
C0683607 (UMLS CUI [8,3])
Illicit medication use
Item
receiving any of the prohibited concomitant medications.
boolean
C0281875 (UMLS CUI [1])