Gender Contraceptive methods | Postmenopausal state Duration
Item
females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Criteria Quantity Fulfill
Item
subjects must meet one of the following:
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Therapy naive | Antiviral Therapy Absent Hepatitis C
Item
treatment-naive: subject has never received antiviral treatment for hepatitis c infection or
boolean
C0919936 (UMLS CUI [1])
C0280274 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
Therapeutic procedure Experience | Non-responder PEGINTERFERON/RIBAVIRIN | Partial responder PEGINTERFERON/RIBAVIRIN | Relapse PEGINTERFERON/RIBAVIRIN
Item
treatment experienced (prior null responders, partial responders or relapsers to pegifn/rbv);
boolean
C0087111 (UMLS CUI [1,1])
C0596545 (UMLS CUI [1,2])
C0919875 (UMLS CUI [2,1])
C1875630 (UMLS CUI [2,2])
C4285679 (UMLS CUI [3,1])
C1875630 (UMLS CUI [3,2])
C0035020 (UMLS CUI [4,1])
C1875630 (UMLS CUI [4,2])
Body mass index
Item
body mass index (bmi) is ≥ 18 to < 38 kg/m^2.
boolean
C1305855 (UMLS CUI [1])
Chronic Hepatitis C Genotype Duration | Liver Cirrhosis | Liver Cirrhosis Absent | Hepatitis C Genotype Duration | Liver Cirrhosis Absent
Item
chronic hcv genotype 1b infection/with or without cirrhosis or hcv genotype 4 infection/without cirrhosis for at least 6 months prior to study screening.
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0023890 (UMLS CUI [2])
C0023890 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0019196 (UMLS CUI [4,1])
C1533728 (UMLS CUI [4,2])
C0449238 (UMLS CUI [4,3])
C0023890 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Hepatitis C virus RNA assay Plasma
Item
subject has plasma hcv rna level > 10,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])
Drug Allergy Severe Life Threatening | Drug Allergy Significant
Item
history of severe, life-threatening or other significant sensitivity to any drug.
boolean
C0013182 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2826244 (UMLS CUI [1,3])
C0013182 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Pregnancy | Pregnancy, Planned | Breast Feeding | Gender Hepatitis C Genotype | Gender Partner Pregnancy | Gender Partner Planned Pregnancy
Item
females who were pregnant or planned to become pregnant, or breastfeeding, or gt4-infected males whose partners were pregnant or planning to become pregnant within 7 months (or per local rbv label) after their last dose of study drug/rbv.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0019196 (UMLS CUI [4,2])
C1533728 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5,1])
C0682323 (UMLS CUI [5,2])
C0032961 (UMLS CUI [5,3])
C0079399 (UMLS CUI [6,1])
C0682323 (UMLS CUI [6,2])
C0032992 (UMLS CUI [6,3])
Substance Use Disorder Excludes Protocol Compliance
Item
recent history of drug or alcohol abuse that could preclude adherence to the protocol.
boolean
C0038586 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Hepatitis B surface antigen positive | HIV antibody positive
Item
positive test result for hepatitis b surface antigen or anti-human immunodeficiency virus (hiv) antibodies.
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])