Age | Chronic Hepatitis C Genotype | Transplantation of liver Cadaver donor | Transplantation of liver Living Donor
Item
patient ≥ 18 years of age with documented chronic hepatitis c virus infection of genotype 1 undergoing liver transplantation from either a deceased donor or living donor.
boolean
C0001779 (UMLS CUI [1])
C0524910 (UMLS CUI [2,1])
C1285573 (UMLS CUI [2,2])
C0023911 (UMLS CUI [3,1])
C0524354 (UMLS CUI [3,2])
C0023911 (UMLS CUI [4,1])
C0348050 (UMLS CUI [4,2])
Informed Consent | Informed Consent Legal Guardian
Item
patient or legal guardian/health care proxy must have read, understood and provided written informed consent and hipaa authorization after the nature of the study has been fully explained.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Hepatitis B surface antigen positive
Item
positive for hepatitis b surface antigen
boolean
C0149709 (UMLS CUI [1])
HIV Seropositivity
Item
positive serology for hiv
boolean
C0019699 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Organ Transplantation
Item
previous history of any organ transplant
boolean
C0029216 (UMLS CUI [1])
Organ Transplantation Combined Planned | Transplantation of liver | Kidney Transplantation
Item
planned receipt of combined organ transplant (e.g. liver and kidney)
boolean
C0029216 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0023911 (UMLS CUI [2])
C0022671 (UMLS CUI [3])
Immunoglobulins, Intravenous | Intravenous Immunoglobulins Planned
Item
receipt or planned receipt of immune globulin (ivig) within 90 days of enrollment
boolean
C0085297 (UMLS CUI [1])
C0085297 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Malignant Neoplasm Extrahepatic | Remission Absent | Systemic Chemotherapy | Systemic Radiation Therapy | Exception Chemoembolization Liver carcinoma | Exception Local Therapy Skin carcinoma
Item
extrahepatic malignancy not currently in remission and/or receiving systemic chemotherapy and/or radiation within 90 days prior to enrollment. exceptions include chemoembolization for hepatocellular carcinoma or cutaneous malignancies managed with local treatment
boolean
C0006826 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0687702 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1883256 (UMLS CUI [3])
C2985381 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0796679 (UMLS CUI [5,2])
C2239176 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1517925 (UMLS CUI [6,2])
C0699893 (UMLS CUI [6,3])
Liver carcinoma | Tumor Burden Criteria Specified
Item
hepatocellular carcinoma with tumor burden outside of the milan criteria
boolean
C2239176 (UMLS CUI [1])
C1449699 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Creatinine measurement, serum
Item
serum creatinine > 2.5 for > or = six months at the time of enrollment
boolean
C0201976 (UMLS CUI [1])
History of Deep vein thrombosis | Family history First Degree Relative Deep Vein Thrombosis | Personal history of pulmonary embolism | Family history of pulmonary embolism
Item
personal or family history (first degree relative) of deep venous thrombosis or pulmonary embolism
boolean
C0459853 (UMLS CUI [1])
C0241889 (UMLS CUI [2,1])
C1517194 (UMLS CUI [2,2])
C0149871 (UMLS CUI [2,3])
C0585968 (UMLS CUI [3])
C2317597 (UMLS CUI [4])
Recipient Allograft liver | Donor Hepatitis C Virus Positive | Donor Hepatitis B core antibody positive
Item
receipt of liver allograft from hcv positive donor or hepatitis b core antibody positive donor
boolean
C1709854 (UMLS CUI [1,1])
C1720451 (UMLS CUI [1,2])
C0013018 (UMLS CUI [2,1])
C4330254 (UMLS CUI [2,2])
C0013018 (UMLS CUI [3,1])
C0262506 (UMLS CUI [3,2])
Recipient Cadaver allograft liver
Item
receipt of liver allograft donated after cardiac death of donor
boolean
C1709854 (UMLS CUI [1,1])
C1720130 (UMLS CUI [1,2])
Antiviral Agents Hepatitis C virus | Exception Sofosbuvir Liver carcinoma | Exception Ribavirin Liver carcinoma
Item
receipt of any antiviral agents (licensed or investigational) for hepatitis c virus within 90 days prior to enrollment, except for hepatocellular carcinoma patients on treatment with sofosbuvir and ribavirin with detectable hcv rna within 60 days of liver transplantation
boolean
C0003451 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2976303 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
C2239176 (UMLS CUI [3,3])
Hepatitis C virus Protease Inhibitors
Item
previous receipt of an hcv protease inhibitor (for subjects enrolling in part 1: telaprevir)
boolean
C0220847 (UMLS CUI [1,1])
C0033607 (UMLS CUI [1,2])
Investigational New Drugs
Item
receipt of any other investigational study product within 30 days prior to enrollment
boolean
C0013230 (UMLS CUI [1])
Epilepsy Requirement Anticonvulsant therapy
Item
seizure disorder requiring anti-convulsant therapy
boolean
C0014544 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0521306 (UMLS CUI [1,3])
Pulmonary arterial hypertension | Sildenafil Required | Tadalafil Required
Item
pulmonary arterial hypertension requiring sildenafil or tadalafil infusion (for subjects enrolling in part 1: telaprevir)
boolean
C2973725 (UMLS CUI [1])
C0529793 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1176316 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Condition At risk Patient safety | Condition At risk Patient Rights | Condition Completion of clinical trial Unlikely
Item
any other condition that in the opinion of the investigator would jeopardize the safety or rights of the patient participating in the study or make it unlikely that the patient could complete the study
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0030706 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2732579 (UMLS CUI [3,2])
C0750558 (UMLS CUI [3,3])