Hepatitis C Genotype Laboratory test result
Item
1. screening laboratory result indicating hcv gt1a infection.
boolean
C0019196 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
Hepatitis C, Chronic
Item
2. chronic hcv infection.
boolean
C0524910 (UMLS CUI [1])
Study Subject Non-cirrhotic
Item
3. subjects must be non-cirrhotic.
boolean
C0681850 (UMLS CUI [1,1])
C0439687 (UMLS CUI [1,2])
Therapy naive | PEGINTERFERON/RIBAVIRIN | PEGINTERFERON/RIBAVIRIN Treatment failure
Item
4. subjects must be treatment-naïve or have documentation that they were adherent to prior pegifn/rbv combination therapy and meet the criteria of prior pegifn/rbv treatment failure.
boolean
C0919936 (UMLS CUI [1])
C1875630 (UMLS CUI [2])
C1875630 (UMLS CUI [3,1])
C0162643 (UMLS CUI [3,2])
Human leukocyte antigen allele Specific
Item
5. subjects must meet specific human leukocyte antigen (hla) allele requirements.
boolean
C0555907 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
1. women who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis B surface antigen positive Immunoassay | HIV antibody positive Immunoassay
Item
2. positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab) positive immunoassay.
boolean
C0149709 (UMLS CUI [1,1])
C0020980 (UMLS CUI [1,2])
C0920548 (UMLS CUI [2,1])
C0020980 (UMLS CUI [2,2])
Abnormality Study Subject Participation Status Inappropriate | Comorbidity Study Subject Participation Status Inappropriate | Exception Hepatitis C
Item
3. clinically significant abnormalities or co-morbidities, other than hcv infection, that make the subject unsuitable for this study or treatment.
boolean
C1704258 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
Study Subject Participation Status | Interventional Study | Anti-hepatitis C (HCV) Agents | Exception PEGINTERFERON | Exception Ribavirin | Exposure to ABT-450 | Exposure to Ombitasvir | Exposure to Dasabuvir | Investigational New Drugs
Item
4. current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-hcv agents other than pegifn or rbv (including previous exposure to abt-450, ombitasvir, or dasabuvir), or receipt of any investigational product within 6 weeks prior to study drug administration.
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
C4324240 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0982327 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0035525 (UMLS CUI [5,2])
C0332157 (UMLS CUI [6,1])
C3712108 (UMLS CUI [6,2])
C0332157 (UMLS CUI [7,1])
C3852670 (UMLS CUI [7,2])
C0332157 (UMLS CUI [8,1])
C3852512 (UMLS CUI [8,2])
C0013230 (UMLS CUI [9])
Solid organ transplant
Item
5. history or solid organ transplant.
boolean
C0730400 (UMLS CUI [1])
Laboratory test result abnormal
Item
6. screening laboratory analysis that shows abnormal results.
boolean
C0438215 (UMLS CUI [1])