Hepatitis C virus RNA assay
Item
has hcv rna ≥ 10,000 iu/ml at the time of screening
boolean
C1272251 (UMLS CUI [1])
Chronic Hepatitis C Genotype determination | Absence Hepatitis C Genotype determination Unsuccessful | Absence Hepatitis C Genotype Mixed
Item
has documented chronic hcv gt 1 with no evidence of non-typeable or mixed gt infection
boolean
C0524910 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C1285573 (UMLS CUI [2,3])
C1272705 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
C0017431 (UMLS CUI [3,3])
C0205430 (UMLS CUI [3,4])
Cirrhotic | Non-cirrhotic
Item
is cirrhotic or non-cirrhotic
boolean
C0439686 (UMLS CUI [1])
C0439687 (UMLS CUI [2])
Therapy naive | Therapy non-responder | Therapy partial responder | Recurrent disease
Item
has hcv treatment status that is treatment naïve, pr null responder; pr partial responder; or prior pr relapser
boolean
C0919936 (UMLS CUI [1])
C0919875 (UMLS CUI [2])
C4285679 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
Coinfection HIV-1 | Therapy naive Antiretroviral therapy | Alternative Quantity Antiretroviral therapy
Item
if human immunodeficiency virus (hiv) co-infected (hiv-1) must be naïve to treatment with any antiretroviral therapy (art) and have no plans to initiate art treatment while participating in this trial, or be on hiv art for at least 8 weeks prior to trial entry (no changes in hiv regimen are allowed within 4 weeks of registration); must also have at least one viable antiretroviral therapy alternative beyond their current regimens in the event of hiv virologic failure and the development of antiretroviral drug resistance
boolean
C0275524 (UMLS CUI [1,1])
C0019704 (UMLS CUI [1,2])
C0919936 (UMLS CUI [2,1])
C1963724 (UMLS CUI [2,2])
C1523987 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1963724 (UMLS CUI [3,3])
Use of Contraceptive methods | Childbearing Potential Absent
Item
use an acceptable method of contraception or not be of childbearing potential
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Decompensated liver disease | Ascites | Bleeding esophageal varices | Bleeding gastric varices | Hepatic Encephalopathy | Sign or Symptom Liver diseases Advanced
Item
has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0155789 (UMLS CUI [3])
C0267209 (UMLS CUI [4])
C0019151 (UMLS CUI [5])
C3540840 (UMLS CUI [6,1])
C0023895 (UMLS CUI [6,2])
C0205179 (UMLS CUI [6,3])
HBV coinfection | Hepatitis B surface antigen positive
Item
is co-infected with hepatitis b virus (e.g., hepatitis b surface antigen [hbsag] positive)
boolean
C2242656 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in Situ | Exception Evaluation Malignant Neoplasms | Exception Evaluation Malignant Neoplasms Suspected
Item
has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0007099 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1261322 (UMLS CUI [6,2])
C0006826 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C1261322 (UMLS CUI [7,2])
C0006826 (UMLS CUI [7,3])
C0750491 (UMLS CUI [7,4])
Liver Cirrhosis | Imaging of liver | Liver carcinoma | Evaluation Liver carcinoma
Item
has cirrhosis and liver imaging within 6 months of day 1 showing evidence of hepatocellular carcinoma (hcc) or is under evaluation for hcc
boolean
C0023890 (UMLS CUI [1])
C2711860 (UMLS CUI [2])
C2239176 (UMLS CUI [3])
C1261322 (UMLS CUI [4,1])
C2239176 (UMLS CUI [4,2])
Mental disorders Pre-existing
Item
has pre-existing psychiatric condition(s)
boolean
C0004936 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Substance Use Disorders
Item
has clinically-relevant drug or alcohol abuse within 12 months of screening
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy Expected | Egg Donation Expected | Gender Reproduction Planned | Gender Sperm donation Planned
Item
is a female and is pregnant or breast-feeding, or expecting to become pregnant or donate eggs from day 1 throughout treatment and until at least 6 months after the last dose of study medication, or longer if dictated by local regulations; or is a male subject and is planning to impregnate or provide sperm donation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
C4053456 (UMLS CUI [4,1])
C1517001 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0035150 (UMLS CUI [5,2])
C1301732 (UMLS CUI [5,3])
C0079399 (UMLS CUI [6,1])
C0871414 (UMLS CUI [6,2])
C1301732 (UMLS CUI [6,3])
Pre-existing condition Interferes with Research results | Laboratory test result abnormal Interferes with Research results | Electrocardiogram abnormal Interferes with Research results | Illness Interferes with Research results | Pre-existing condition Investigational New Drugs At risk | Laboratory test result abnormal Investigational New Drugs At risk | Electrocardiogram abnormal Investigational New Drugs At risk | Illness Investigational New Drugs At risk
Item
has any preexisting condition or prestudy laboratory abnormality, electrocardiogram (ecg) abnormality or history of any illness, which, in the opinion of the investigator, might confound the results of the trial or pose additional risk in administering the study drug(s) to the subject
boolean
C0521987 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0522055 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0221423 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
C0521987 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0438215 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C0522055 (UMLS CUI [7,1])
C0013230 (UMLS CUI [7,2])
C1444641 (UMLS CUI [7,3])
C0221423 (UMLS CUI [8,1])
C0013230 (UMLS CUI [8,2])
C1444641 (UMLS CUI [8,3])
Life Threatening Adverse Event Severe
Item
has a life-threatening severe ae (sae) during the screening period
boolean
C1517874 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Hepatitis, Chronic | Exception Etiology HCV | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Hepatitis, Autoimmune
Item
has evidence of history of chronic hepatitis not caused by hcv, including but not limited to nonalcoholic steatohepatitis (nash), drug-induced hepatitis, and autoimmune hepatitis
boolean
C0019189 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
C3241937 (UMLS CUI [3])
C1262760 (UMLS CUI [4])
C0241910 (UMLS CUI [5])