Haematology
Complete Blood Count
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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
Liver Chemistry
ALT
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 (excluded from this Protocol) Child-Pugh Class C=score >9 (excluded from this Protocol)
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MELD Score = 3.78 * {ln [serum bilirubin (mg/dL)]} + 11.2 *{ln[INR]} + 9.57*{ln[serum creatinine (mg/dL)]} + 6.43.
float
Renal Assessments
Serum creatinine
float
determined by the Cockcroft- Gault formula
integer
UP/CR
float
GFR = (140- years of age)*(weight (kg))*[0.85 if female]/(creatinine (mg/dL)*72). Baseline weight and age will be used for all GFR calculations.
float
if required
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if required
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if required
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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
in LOG IU/ML Summary of Log-Transformed HCV RNA (LOG IU/ML) at Baseline (Pre-antiviral Safety Population)
float
HCV genotype
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Subject lifestyle/risk factor assessment should be conducted to determine if additional tests are required to ensure subject remains eligible for the study. This may include screening subjects for HIV and Hepatitis B if required.
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Subject lifestyle/risk factor assessment should be conducted to determine if additional tests are required to ensure subject remains eligible for the study. This may include screening subjects for HIV and Hepatitis B if required.
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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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