Japanese | Chronic Hepatitis C Genotype determination | Absence Hepatitis C Genotype determination Unsuccessful | Absence Hepatitis C Genotype Mixed
Item
has documented chronic japanese hcv genotype (gt) 1 with no evidence of non-typeable or mixed gt infection
boolean
C1556094 (UMLS CUI [1])
C0524910 (UMLS CUI [2,1])
C1285573 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
C1285573 (UMLS CUI [3,3])
C1272705 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C0019196 (UMLS CUI [4,2])
C0017431 (UMLS CUI [4,3])
C0205430 (UMLS CUI [4,4])
Therapy naive | Intolerance Interferon Anti-HCV Agents | Therapy non-responder Interferon Anti-HCV Agents | Intolerance Interferon DIRECT ACTING ANTIVIRALS | Therapy non-responder Interferon DIRECT ACTING ANTIVIRALS | Intolerance DIRECT ACTING ANTIVIRALS | Therapy non-responder DIRECT ACTING ANTIVIRALS
Item
is treatment-naïve, or intolerant or non-responder to prior anti-hcv ifn-based treatment without direct acting antiviral (daa) therapy, prior ifn-based treatment with daa therapy, or prior daa therapy
boolean
C0919936 (UMLS CUI [1])
C0231199 (UMLS CUI [2,1])
C3652465 (UMLS CUI [2,2])
C4324239 (UMLS CUI [2,3])
C0919875 (UMLS CUI [3,1])
C3652465 (UMLS CUI [3,2])
C4324239 (UMLS CUI [3,3])
C0231199 (UMLS CUI [4,1])
C3652465 (UMLS CUI [4,2])
C3653501 (UMLS CUI [4,3])
C0919875 (UMLS CUI [5,1])
C3652465 (UMLS CUI [5,2])
C3653501 (UMLS CUI [5,3])
C0231199 (UMLS CUI [6,1])
C3653501 (UMLS CUI [6,2])
C0919875 (UMLS CUI [7,1])
C3653501 (UMLS CUI [7,2])
Childbearing Potential Contraceptive methods
Item
agrees to the use of contraception if a female of reproductive potential
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
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 | HIV coinfection
Item
is coinfected with hepatitis b virus or human immunodeficiency virus (hiv)
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in Situ
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 carcinoma in situ
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])
C0007099 (UMLS CUI [4,2])
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 (part 2 only)
boolean
C0023890 (UMLS CUI [1])
C2711860 (UMLS CUI [2])
C2239176 (UMLS CUI [3])
C1261322 (UMLS CUI [4,1])
C2239176 (UMLS CUI [4,2])
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
Item
is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs from day 1 and continue throughout treatment and follow-up (or longer if dictated by local regulations)
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])
Condition Any
Item
has any of the following conditions:
boolean
C0348080 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Organ Transplantation | Hemopoietic stem cell transplant | Exception Transplanted cornea | Exception Hair transplant
Item
organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
boolean
C0029216 (UMLS CUI [1])
C0472699 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0080251 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0191626 (UMLS CUI [4,2])
Poor venous access
Item
poor venous access
boolean
C0577866 (UMLS CUI [1])
Operation on stomach | Stomach Stapling | Gastric Bypass | Malabsorption Syndrome | Celiac Disease
Item
history of gastric surgery (e.g., stapling, bypass) or subject with a history of malabsorption disorders (e.g., celiac sprue disease)
boolean
C0192398 (UMLS CUI [1])
C0149701 (UMLS CUI [2])
C0017125 (UMLS CUI [3])
C0024523 (UMLS CUI [4])
C0007570 (UMLS CUI [5])
Medical condition Resulting in Hospitalization | Exception Minor Surgical Procedures elective
Item
history of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment, other than for minor elective procedures
boolean
C3843040 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0038904 (UMLS CUI [2,2])
C0439608 (UMLS CUI [2,3])
Medical condition Requirement Hospitalization
Item
medical/surgical conditions that may result in a need for hospitalization during the period of the study
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Medical condition Requirement TNF Blocker | Medical condition Requirement Immunosuppressive Agents
Item
any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tnf antagonists, or other immunosuppressant drugs during the course of the trial
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3653708 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C2343929 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0021081 (UMLS CUI [3,3])
Hepatitis, Chronic | Exception Etiology HCV | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Hepatitis, Autoimmune
Item
has 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])