Chronic Hepatitis C Genotype | Absence Infection Genotype Mixed | Hepatitis C antibody positive | Hepatitis C RNA positive | Hepatitis C virus genotype Positive
Item
documented chronic hcv gt1, gt4, or gt6 with no evidence of non-typable or mixed genotype infection (positive for anti-hcv antibody, hcv rna, or any of the listed gts at least 6 months prior to screening must be confirmed by screening lab results)
boolean
C0524910 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C3714514 (UMLS CUI [2,2])
C0017431 (UMLS CUI [2,3])
C0205430 (UMLS CUI [2,4])
C0281863 (UMLS CUI [3])
C0855842 (UMLS CUI [4])
C1148363 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
Liver Cirrhosis Metavir score f4 Biopsy of liver | Liver Cirrhosis Fibroscan | Fibrosure | FibroTest Score Measurement | AST to platelet ratio index
Item
cirrhosis defined by: liver biopsy showing cirrhosis metavir f4; or fibroscan showing cirrhosis with a result of >12.5 kpa; or fibrosure® (fibrotest®) score of >0.75 and an aspartate aminotransferase (ast): platelet ratio index (apri) of >2
boolean
C0023890 (UMLS CUI [1,1])
C4481041 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0023890 (UMLS CUI [2,1])
C4522043 (UMLS CUI [2,2])
C1955263 (UMLS CUI [3])
C3642160 (UMLS CUI [4])
C4483916 (UMLS CUI [5])
Liver Cirrhosis Absent Biopsy of liver | Fibroscan | Fibrosure | FibroTest Score Measurement | AST to platelet ratio index
Item
absence of cirrhosis defined by: liver biopsy showing absence of cirrhosis, or fibroscan with a result of ≤12.5 kpa, or fibrosure® (fibrotest®) score of <= 0.48 and apri of <=1
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C4522043 (UMLS CUI [2])
C1955263 (UMLS CUI [3])
C3642160 (UMLS CUI [4])
C4483916 (UMLS CUI [5])
Therapy naive Anti-hepatitis C (HCV) Agents | Pegylated interferon alfa Ineligible
Item
hcv treatment status of treatment naïve (naïve to all anti-hcv treatment) and can also be ineligible to take pegylated interferon
boolean
C0919936 (UMLS CUI [1,1])
C4324240 (UMLS CUI [1,2])
C0907160 (UMLS CUI [2,1])
C1512714 (UMLS CUI [2,2])
Female infertility | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods
Item
female participant not of reproductive potential, or female of reproductive potential and agrees to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug (using abstinence or acceptable methods of contraception)
boolean
C0021361 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Decompensated liver disease | Ascites | Bleeding esophageal varices | Bleeding gastric varices | Hepatic Encephalopathy | Sign or Symptom Liver disease Advanced | Study Subject Cirrhotic Child-Pugh Classification | Study Subject Cirrhotic Child-Pugh-Turcotte score
Item
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. for cirrhotics, participants who are child-pugh class b or c or who have a pugh-turcotte (cpt) score >6
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])
C0681850 (UMLS CUI [7,1])
C0439686 (UMLS CUI [7,2])
C2347612 (UMLS CUI [7,3])
C0681850 (UMLS CUI [8,1])
C0439686 (UMLS CUI [8,2])
C3854424 (UMLS CUI [8,3])
HBV coinfection | HIV Coinfection
Item
co-infection with hepatitis b virus or human immunodeficiency virus (hiv)
boolean
C2242656 (UMLS CUI [1])
C4505456 (UMLS CUI [2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in Situ Treated | Evaluation Cancer Other | Evaluation Malignant Neoplasms Suspected
Item
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])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0007099 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1261322 (UMLS CUI [6,1])
C1707251 (UMLS CUI [6,2])
C1261322 (UMLS CUI [7,1])
C0006826 (UMLS CUI [7,2])
C0750491 (UMLS CUI [7,3])
Liver carcinoma | Evaluation Liver carcinoma
Item
evidence of hepatocellular carcinoma (hcc) or under evaluation for hcc
boolean
C2239176 (UMLS CUI [1])
C1261322 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
Study Subject Participation Status | Compound Investigational
Item
currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study
boolean
C2348568 (UMLS CUI [1])
C1706082 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Substance Use Disorders
Item
clinically-relevant drug or alcohol abuse within 12 months of screening
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding | Egg Donation Expected
Item
pregnant, breast-feeding, or expecting to conceive or donate eggs from day 1 throughout treatment and 14 days after the last dose of study medication or longer if dictated by local regulations
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4053456 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
Organ Transplantation | Hemopoietic stem cell transplant | Exception Keratoplasty | Exception Hair transplant procedure
Item
organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
boolean
C0029216 (UMLS CUI [1])
C0472699 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0010042 (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 history of malabsorption disorder (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 Requirement CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Medical condition Requirement Tumor necrosis factor alpha inhibitors | 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])
C3653350 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0021081 (UMLS CUI [3,3])
Hepatitis, Chronic | Independent of Hepatitis C virus | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Hepatitis, Autoimmune
Item
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])
C0332291 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
C3241937 (UMLS CUI [3])
C1262760 (UMLS CUI [4])
C0241910 (UMLS CUI [5])