Haematology
Complete Blood Count
text
red blood cell
float
haemoglobin
float
haematocrit
float
platelet count
float
WBC
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neutrophils
float
lymphocytes
float
monocytes
float
eosinophils
float
basophils
float
MCV
float
INR
float
PT
integer
aPTT
integer
Thrombopoietin
float
Liver Chemistry Assessments
Albumin
float
CPK
float
LDH
float
Measure: Total bilirubin, Serum albumin, INR, Ascites, Hepatic encephalopathy
integer
Child-Pugh Class A=score 5-6 Child-Pugh Class B=score 7-9
text
The Model for End-Stage Liver Disease (MELD) score is a function of serum bilirubin, serum creatinine, and the INR for prothrombin time. MELD Score = 3.78 * {ln [serum bilirubin (mg/dL)]} + 11.2 *{ln[INR]} + 9.57*{ln[serum creatinine (mg/dL)]} + 6.43.
float
The following are required for subjects who meet the ALT and bilirubin threshold stopping criteria but are optional for other abnormal liver chemistries
float
anti-smooth muscle antibody
float
Type 1 anti-liver kidney microsomal antibodies
float
Hepatitis A IgM antibody
float
Hepatitis B surface antigen and Hepatitis B Core Antibody (IgM)
float
Cytomegalovirus IgM antibody
float
(or if unavailable, obtain heterophile antibody or monospot testing)
float
(if subject resides outside the USA or Canada, or has travelled outside USA or Canada in past 3 months)
float
Renal Laboratory Parameters
Serum creatinine
float
Creatinine clearance
integer
UP/CR
float
GFR was calculated by the Cockcroft-Gault formula.
float
Microscopic Urine Analysis
text
If the UP/CR is above the ULN, then a urine protein electrophoresis will also be performed
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Urinalysis Dipstick
Urine Urobilinogen
float
Urine Protein
float
Urine Occult Blood
integer
Urine Ketones
float
Urine Bilirubin
integer
Urine Glucose
float
Urine pH
float
Urine Specific Gravity
float
Other Laboratory Screenings
HCV RNA
float
HVR RNA
float
HCV genotype 2/3 HCV genotype non 2/3
integer
HCV FibroSURE is a noninvasive blood test that combines the quanitative results of 6 serum biochemical markers (α2-macroglobulin,haptoglobin, apolipoprotein A1, bilirubin, γ-glutamyl transpeptidase (GGT), and ALT), with a subject’s age and gender to generate a measure of fibrosis/cirrhosis and necroinflammatory activity in the liver. It provides a numerical quantitative estimate of liver fibrosis ranging from 0.00 to 1.00 corresponding the the Metavir scoring system of stages F0 to F4 (F0=no fibrosis, F1=portal fibrosis, F2=bridging fibrosis with few septa, F3=bridging fibrosis with many septa, F4=cirrhosis). The test also provides a numerical quantitative estimate of necroinflammatory activity ranging from 0.00 to 1.00 corresponding to the Metavir scoring system of grade A0 to A3. (A0=no activity, A1=minimal activity, A2=moderate activity, A3=severe activity).
integer
Necroinflammatory Activity (METAVIR)
text
The Hepatitis C Viral RNA quantitative transcription-mediated amplification (TMA) was used to quantitate the level of HCV RNA in serum or plasma.
float
A screening beta-human chorionic gonadotrophin (beta-hCG) pregnancy test was mandatory for all female subjects of childbearing potential per local standards
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HIV screening
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