Chronic Hepatitis C Genotype determination | Absence Hepatitis C virus genotype determination Unsuccessful | Absence Hepatitis C virus genotype Mixed
Item
documented chronic hcv gt1 infection (with no evidence of non-typable or mixed genotype)
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C1148363 (UMLS CUI [3,2])
C0205430 (UMLS CUI [3,3])
Liver Cirrhosis Absent | Liver Cirrhosis Criteria | Metavir score | Fibroscan | FibroTest Score Measurement | AST to platelet ratio index | DIRECT ACTING ANTIVIRALS | boceprevir | telaprevir | simeprevir | sofosbuvir | PEGINTERFERON | Ribavirin
Item
absence of cirrhosis, or cirrhosis with these criteria: metavir f4, or fibroscan with result >12.5 kpa, or fibrosure® (fibrotest®) score of >0.75 + aspartate aminotransferase (ast): platelet ratio index (apri) of >2- prior regimen containing an approved daa (boceprevir, telaprevir, simeprevir, or sofosbuvir), pegylated interferon, and/or rbv
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C3888527 (UMLS CUI [3])
C4522043 (UMLS CUI [4])
C3642160 (UMLS CUI [5])
C4483916 (UMLS CUI [6])
C3653501 (UMLS CUI [7])
C1738934 (UMLS CUI [8])
C1876229 (UMLS CUI [9])
C2605855 (UMLS CUI [10])
C2976303 (UMLS CUI [11])
C0982327 (UMLS CUI [12])
C0035525 (UMLS CUI [13])
Females & males of reproductive potential Sexual Abstinence | Females & males of reproductive potential Contraceptive methods Quantity | Females & males of reproductive potential Partner Contraceptive methods Quantity
Item
participants of reproductive potential must agree to remain truly abstinent or use (or have their partner use) 2 acceptable methods of birth control from at least 2 weeks prior to day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations
boolean
C4034483 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C4034483 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
DIRECT ACTING ANTIVIRALS Hepatitis C | Exception Boceprevir | Exception Telaprevir | Exception Simeprevir | Exception Sofosbuvir | Exception PEGINTERFERON | Exception Ribavirin
Item
received any hcv regimen containing a daa with the exception of boceprevir, telaprevir, simeprevir, or sofosbuvir in combination with pegylated interferon and/or rbv
boolean
C3653501 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1738934 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1876229 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C2605855 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C2976303 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0982327 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0035525 (UMLS CUI [7,2])
Decompensated liver disease | Liver Cirrhosis
Item
evidence of decompensated liver disease or cirrhosis
boolean
C4075847 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
HBV coinfection | HIV coinfection
Item
co-infected 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 of uterine cervix | Exception Carcinoma in Situ | Exception Evaluation Cancer Other | Exception Evaluation Cancer Other 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 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])
C1707251 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C1261322 (UMLS CUI [7,2])
C1707251 (UMLS CUI [7,3])
C0750491 (UMLS CUI [7,4])
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 | Investigational New Drugs
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])
C0013230 (UMLS CUI [2])
Substance Use Disorders
Item
clinically-relevant drug or alcohol abuse within 12 months of screening
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding | Ovum Receive Expected | Sperm Receive Expected | Egg Donation Expected | Sperm donation Expected
Item
pregnant, breast-feeding, or expecting to conceive or donate eggs or sperm from at least 2 weeks prior to 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])
C0029974 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C1517001 (UMLS CUI [3,3])
C0037868 (UMLS CUI [4,1])
C1514756 (UMLS CUI [4,2])
C1517001 (UMLS CUI [4,3])
C4053456 (UMLS CUI [5,1])
C1517001 (UMLS CUI [5,2])
C0871414 (UMLS CUI [6,1])
C1517001 (UMLS CUI [6,2])
Gender Partner Pregnancy
Item
male participant whose female partner (s) is/are pregnant
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Organ Transplantation | Hemopoietic stem cell transplant | Exception Cornea transplant | 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 sprue
Item
history of gastric surgery (e.g., stapling, bypass) or 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])
Hemoglobinopathy | Thalassaemia major
Item
hemoglobinopathy, including, but not limited to, thalassemia major
boolean
C0019045 (UMLS CUI [1])
C0002875 (UMLS CUI [2])
Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE chronic
Item
any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids 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])
Hepatitis, Chronic | Absence Cause HCV | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Hepatitis, Autoimmune
Item
evidence or 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])
C0332197 (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])