Hepatitis B, Chronic | Tenofovir | entecavir
Item
documented history of chronic hepatitis b infection currently being treated with tenofovir or entecavir for at least 3 months
boolean
C0524909 (UMLS CUI [1])
C0384228 (UMLS CUI [2])
C0971023 (UMLS CUI [3])
Hepatitis B Surface Antigens Titer Measurable
Item
measurable titer of hbsag
boolean
C0019168 (UMLS CUI [1,1])
C0475208 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
Hepatitis B DNA Measurement
Item
hbv dna level < 2 log copies/ml or 10² copies/ml
boolean
C3641250 (UMLS CUI [1])
Child-Pugh Clinical Classification | Fibroscan | Score Median | Interquartile Range
Item
no more than child-pugh score of 5 plus a valid fibroscan® of at least 10 readings with a median score of <7 and interquartile range of < 30%
boolean
C4050412 (UMLS CUI [1])
C4522043 (UMLS CUI [2])
C0449820 (UMLS CUI [3,1])
C2939193 (UMLS CUI [3,2])
C1711350 (UMLS CUI [4])
Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
adequate liver function, aspartate ast and alt ≤2 x uln
boolean
C0232741 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Renal function | Creatinine measurement, serum
Item
adequate renal function as evidenced by creatinine ≤2 mg/dl
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Study Subject Participation Status | Interventional Study
Item
participation in any interventional study within 4 weeks prior to screening
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
HIV Infection | Hepatitis C | Liver disease | Liver Cirrhosis Child-Pugh Classification
Item
known hiv infection, hepatitis c, or other significant hepatic disorder including cirrhosis (child-pugh class b or c)
boolean
C0019693 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0023890 (UMLS CUI [4,1])
C4050412 (UMLS CUI [4,2])
Illness Serious | Autoimmune Disease | Liver diseases
Item
serious illness or autoimmune disease or other known liver disease
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0004364 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Decreased cardiac function | Cardiac Arrhythmia Uncontrolled | Pharmacotherapy | Heart Disease
Item
impaired cardiac function, uncontrolled cardiac arrhythmias despite medications, or clinically significant cardiac disease
boolean
C0232166 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0013216 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
currently breast feeding, pregnant or planning on becoming pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Hypersensitivity Birinapant Component | Hypersensitivity Placebo Component | Hypersensitivity Citric Acid
Item
known allergy or hypersensitivity to any of the formulation components of birinapant or placebo, including citric acid
boolean
C0020517 (UMLS CUI [1,1])
C3658709 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0032042 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0055819 (UMLS CUI [3,2])
Cranial nerve palsy
Item
history of cranial nerve palsy
boolean
C0151311 (UMLS CUI [1])
Anti-tumor necrosis factor therapy
Item
current treatment with anti-tnf therapies or has received treatment with anti-tnf therapies within the last 6 months
boolean
C0281481 (UMLS CUI [1])
Anti-Inflammatory Agents, Non-Steroidal
Item
use of non-steroidal anti-inflammatory drugs
boolean
C0003211 (UMLS CUI [1])