Hepatitis C Genotype Laboratory test result
Item
1. screening laboratory result indicating hcv genotype 1 (gt1) a 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])
Protocol Compliance | Informed Consent
Item
4. subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an institutional review board (irb) approved informed consent.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [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 | Therapeutic procedure Hepatitis C virus | PEGINTERFERON | Ribavirin | Antiviral Agents Investigational Hepatitis C virus | Antiviral Agents Hepatitis C virus | Protease Inhibitors | Other Coding | Hepatitis C Virus NS5A Inhibitor
Item
4. current enrollment in another interventional clinical study. previous use of any hcv treatments including pegylated interferon (pegifn), ribavirin, or any direct acting antiviral agent, either investigational or approved, for hcv including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or ns5a inhibitors.
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0220847 (UMLS CUI [3,2])
C0982327 (UMLS CUI [4])
C0035525 (UMLS CUI [5])
C0003451 (UMLS CUI [6,1])
C1517586 (UMLS CUI [6,2])
C0220847 (UMLS CUI [6,3])
C0003451 (UMLS CUI [7,1])
C0220847 (UMLS CUI [7,2])
C0033607 (UMLS CUI [8])
C3846158 (UMLS CUI [9])
C3883357 (UMLS CUI [10])
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])