Hepatitis C Genotype
Item
genotype 4 hepatitis c virus (hcv) infection (confirmed at screening)
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay Plasma
Item
plasma hcv ribonucleic acid (rna) of >10,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])
Therapy naive | Therapy Experience | Therapy non-responder | Recurrent disease | Response Previous
Item
participants should be either treatment-naïve or treatment-experienced (non-responder or relapser) with adequate documentation of previous response
boolean
C0919936 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0596545 (UMLS CUI [2,2])
C0919875 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
C1704632 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
Informed Consent
Item
participants must have voluntarily signed an informed consent form (icf) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. to participate in the optional pharmacogenomic component in this study (exploratory host genotyping), participants must have voluntarily signed a separate icf for this component (where local regulations permit). refusal to give consent for this component does not exclude a participant from participation in the core study.
boolean
C0021430 (UMLS CUI [1])
Biopsy of liver | Histology Consistent with Chronic Hepatitis C
Item
participants must have had a liver biopsy within 3 years prior to screening (or between screening and baseline visit) with histology consistent with chronic hcv infection
boolean
C0193388 (UMLS CUI [1])
C0344441 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
Hepatitis C | HCV coinfection | Exception Hepatitis C virus genotype
Item
has an infection/co-infection with non-genotype 4 hcv
boolean
C0019196 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1533728 (UMLS CUI [3,2])
Coinfection HIV-1 | Coinfection HIV-2 | HIV-1 Antibodies Positive | HIV-2 Antibodies Positive
Item
has a co-infection with human immunodeficiency virus (hiv) type 1 or type 2 (hiv-1 or hiv-2) (positive hiv-1 or hiv-2 antibodies test at screening).
boolean
C0275524 (UMLS CUI [1,1])
C0019704 (UMLS CUI [1,2])
C0275524 (UMLS CUI [2,1])
C0019707 (UMLS CUI [2,2])
C1254603 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C1255639 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
Laboratory test result abnormal
Item
has any of the following laboratory abnormalities:
boolean
C0438215 (UMLS CUI [1])
Platelet Count measurement
Item
1. platelet count <90,000/mm3;
boolean
C0032181 (UMLS CUI [1])
Absolute neutrophil count | Blacks
Item
2. absolute neutrophil count (anc) <1500 cells/mm3 (blacks: <1200 cells/mm3);
boolean
C0948762 (UMLS CUI [1])
C0005680 (UMLS CUI [2])
Hemoglobin measurement | Gender
Item
3. hemoglobin <12 g/dl for women and <13 g/dl for men;
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Creatinine measurement, serum
Item
4. creatinine >1.5 mg/dl;
boolean
C0201976 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
5. alt and/or ast >10 x upper limit of normal (uln);
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
SERUM TOTAL BILIRUBIN ELEVATED
Item
6. total serum bilirubin >1.5 x uln;
boolean
C0595866 (UMLS CUI [1])
Alpha one fetoprotein measurement
Item
7. alpha-fetoprotein [afp] >50 ng/ml;
boolean
C0201539 (UMLS CUI [1])
Measurement of albumin in plasma
Item
8. albumin plasma concentration <3.5 g/dl;
boolean
C3525688 (UMLS CUI [1])
Prothrombin time assay | International Normalized Ratio
Item
9. prothrombin time (pt) expressed as international normalized ratio (inr) >1.5. note: retesting of abnormal laboratory values that leads to exclusion will be allowed once using an unscheduled visit during the screening period to assess eligibility.
boolean
C0033707 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Therapeutic procedure Illicit
Item
used disallowed concomitant therapy
boolean
C0087111 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
Hepatic decompensation | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
has evidence of hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy)
boolean
C1394798 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])