Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Asunaprevir Dose Quantity | Daclatasvir Dose Quantity
Item
subjects must have received at least one dose of asunaprevir and/or daclatasvir
boolean
C3491974 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3252090 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Study Subject Participation Status Clinical Trial Daclatasvir | Study Subject Participation Status Clinical Trial Asunaprevir | Enrollment Independent of Virologic Response
Item
subjects participating in daclatasvir and/or asunaprevir studies (ie, protocol numbers beginning with ai443, ai444 or ai447) may enroll regardless of virologic response
boolean
C2348568 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C3252090 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C3491974 (UMLS CUI [2,3])
C1516879 (UMLS CUI [3,1])
C0332291 (UMLS CUI [3,2])
C4053862 (UMLS CUI [3,3])
Clinical Trial Previous | Follow-up Completed
Item
completed the required post-treatment follow-up period in previous study
boolean
C0008976 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Study Subject Participation Status | Clinical Trial Previous Completed
Item
must enroll in this study within 6 months of completing previous bms study or within 6 months of protocol availability at the clinical site
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Age
Item
men and women, ages 18 and older
boolean
C0001779 (UMLS CUI [1])
Antiviral Therapy Chronic Hepatitis C | Immunomodulatory therapy Chronic Hepatitis C
Item
subject must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis c (chc) after completion of the previous study during which asunaprevir and/or daclatasvir were administered
boolean
C0280274 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
C1963758 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Study Subject Participation Status | Clinical Trial | Exception Interventional procedure Absent
Item
subject must not be participating in any other trial, excluding non-interventional trials
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Prisoners | Study Subject incarcerated
Item
prisoners or subjects who are involuntarily incarcerated
boolean
C0033167 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C0392751 (UMLS CUI [2,2])
Study Subject Incarcerated | Psychiatric therapeutic procedure | Treatment Physical illness | Treatment Communicable Disease
Item
subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
boolean
C0681850 (UMLS CUI [1,1])
C0392751 (UMLS CUI [1,2])
C0204523 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0683323 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0009450 (UMLS CUI [4,2])