Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic Hepatitis C Genotype Duration
Item
chronic hepatitis c genotype 1 of >/= 6 months duration at screening
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
PEGINTERFERON Absent | Interferon Absent | DIRECT ACTING ANTIVIRALS Study Subject Participation Status Excluded
Item
part 1 and part 2: naïve to treatment with interferon (pegylated or non-pegylated). patients who have participated in studies investigating a direct-acting antiviral agent with or without interferon are excluded
boolean
C0982327 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3653501 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
Therapy Experience | Non-responder Interferon therapy
Item
part 2: treatment experienced patients having a previous null response to treatment with interferon containing regimen
boolean
C0087111 (UMLS CUI [1,1])
C0596545 (UMLS CUI [1,2])
C0919875 (UMLS CUI [2,1])
C0279030 (UMLS CUI [2,2])
Biopsy of liver | Evaluation | Fibroscan | Liver Cirrhosis Absent | Absence Liver Cirrhosis Incomplete | Absence Transition Liver Cirrhosis
Item
liver biopsy or non-invasive (e.g. fibroscan) evaluation in the past 24 calendar months showing absence of cirrhosis or incomplete/transition to cirrhosis
boolean
C0193388 (UMLS CUI [1])
C1261322 (UMLS CUI [2])
C4522043 (UMLS CUI [3])
C0023890 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0332197 (UMLS CUI [5,1])
C0023890 (UMLS CUI [5,2])
C0205257 (UMLS CUI [5,3])
C0332197 (UMLS CUI [6,1])
C2700061 (UMLS CUI [6,2])
C0023890 (UMLS CUI [6,3])
Body mass index | Body Weight
Item
body mass index (bmi) 18 to 35 kg/m2 inclusive and body weight >/= 45 kg
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Pregnancy | Breast Feeding | Gender Partner Pregnancy | Gender Partner Breast Feeding
Item
pregnant or lactating women or males with female partners who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C0006147 (UMLS CUI [4,3])
Decompensated liver disease | Liver Dysfunction
Item
decompensated liver disease or impaired liver function (as defined by protocol)
boolean
C4075847 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
Liver Cirrhosis | Liver Cirrhosis Incomplete | Transition Liver Cirrhosis
Item
cirrhosis or incomplete/transition to cirrhosis
boolean
C0023890 (UMLS CUI [1])
C0023890 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])
C2700061 (UMLS CUI [3,1])
C0023890 (UMLS CUI [3,2])
Chronic liver disease | Exception Hepatitis C
Item
non- hepatitis c chronic liver disease
boolean
C0341439 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Hepatitis B positive | HIV Seropositivity
Item
positive for hepatitis b or hiv infection
boolean
C0856706 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Kidney Disease Pre-existing
Item
history of pre-existing renal disease
boolean
C0022658 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Heart Disease Severe
Item
history of severe cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Neoplastic disease | Exception Skin carcinoma Localized | Exception Carcinoma in situ of skin
Item
history of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
boolean
C1882062 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C0392752 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0154073 (UMLS CUI [3,2])
Drug abuse | Cannabinoids allowed
Item
history of drug abuse within the last year; history of cannabinoid use is not excluded
boolean
C0013146 (UMLS CUI [1])
C0006864 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Alcohol abuse | Alcohol consumption U/day
Item
evidence of alcohol abuse within 1 year of screening and consumption of more than 2 units of alcohol per day
boolean
C0085762 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE
Item
medical condition that requires use of systemic corticosteroids
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3653708 (UMLS CUI [1,3])
Warfarin Recent | Anticoagulants Recent | Warfarin Expected | Anticoagulants Expected
Item
received warfarin or other anticoagulants during the 21 days immediately prior to screening or is expected to require warfarin or other anticoagulants during the study
boolean
C0043031 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0003280 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0043031 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
C0003280 (UMLS CUI [4,1])
C1517001 (UMLS CUI [4,2])
Therapeutic procedure Significant Anticipated | Patient need for Therapeutic procedure Significant | Pharmaceutical Preparations Excluded | Nutrients Excluded | Pharmaceutical Preparations Contraindicated Ritonavir | Pharmaceutical Preparations Contraindicated Hormonal contraception
Item
anticipated use or need for significant medical treatment during the study or use of concomitant medications or nutrients that are excluded by protocol (e.g. drugs that are contraindicated with ritonavir, hormonal methods of contraception)
boolean
C0087111 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C3840775 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0678695 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0013227 (UMLS CUI [5,1])
C1444657 (UMLS CUI [5,2])
C0292818 (UMLS CUI [5,3])
C0013227 (UMLS CUI [6,1])
C1444657 (UMLS CUI [6,2])
C2985296 (UMLS CUI [6,3])