ID

43968

Description

The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR). NCT00516321 https://clinicaltrials.gov/ct2/show/NCT00516321 Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a Plus Ribavirin

Link

https://clinicaltrials.gov/ct2/show/NCT00516321

Keywords

  1. 5/31/17 5/31/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Lab panels NCT00516321

Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Lab panels NCT00516321

Chemistry
Description

Chemistry

Alias
UMLS CUI-1
C2347783
UMLS CUI-2
C0022885
Alkaline phosphatase
Description

Alkaline phosphatase

Data type

float

Measurement units
  • [iU]/L
Alias
UMLS CUI [1]
C0201850
[iU]/L
ALT
Description

ALT

Data type

float

Measurement units
  • [iU]/L
Alias
UMLS CUI [1]
C0201836
[iU]/L
AST
Description

AST

Data type

float

Measurement units
  • [iU]/L
Alias
UMLS CUI [1]
C0201899
[iU]/L
serum urea
Description

Urea

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0523961
mmol/L
bicarbonate
Description

bicarbonate

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0202059
mmol/L
chloride
Description

chloride

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0201952
mmol/L
glucose
Description

glucose

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0202042
mmol/L
total bilirubin
Description

total bilirubin

Data type

float

Measurement units
  • umol/L
Alias
UMLS CUI [1]
C1278039
umol/L
direct bilirubin
Description

direct bilirubin

Data type

float

Measurement units
  • umol/L
Alias
UMLS CUI [1]
C0201916
umol/L
Indirect Bilirubin Levels
Description

Indirect Bilirubin

Data type

float

Measurement units
  • umol/L
Alias
UMLS CUI [1]
C1881193
umol/L
uric acid
Description

uric acid

Data type

float

Measurement units
  • umol/L
Alias
UMLS CUI [1]
C0202239
umol/L
blood urea nitrogen
Description

blood urea nitrogen

Data type

float

Alias
UMLS CUI [1]
C0005845
sodium
Description

sodium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0337443
mmol/L
potassium
Description

potassium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0202194
mmol/L
calcium
Description

calcium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0201925
mmol/L
magnesium
Description

Urinary wasting of sodium, potassium and magnesium may occur as a result of renal tubular damage. The occurrences of hypokalemia, hyponatremia or hypomagnesemia were investigated and compared between the placebo and eltrombopag treatment groups.

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0373675
mmol/L
phosphate
Description

phosphate

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0523826
mmol/L
total protein
Description

total protein

Data type

float

Measurement units
  • g/L
Alias
UMLS CUI [1]
C0036836
g/L
Alpha-fetoprotein
Description

Alpha-fetoprotein

Data type

float

Measurement units
  • ng/mL
Alias
UMLS CUI [1]
C0201539
ng/mL
Haematology
Description

Haematology

Alias
UMLS CUI-1
C0474523
UMLS CUI-2
C0022885
Complete Blood Count
Description

Complete Blood Count

Data type

text

Alias
UMLS CUI [1]
C0009555
red blood cell count
Description

red blood cell

Data type

float

Measurement units
  • 10*6/uL
Alias
UMLS CUI [1]
C0014772
10*6/uL
haemoglobin
Description

haemoglobin

Data type

float

Measurement units
  • g/L
Alias
UMLS CUI [1]
C0518015
g/L
haematocrit
Description

haematocrit

Data type

float

Alias
UMLS CUI [1]
C0018935
platelet count
Description

platelet count

Data type

float

Measurement units
  • 10*3/uL
Alias
UMLS CUI [1]
C0005821
10*3/uL
WBC (White Blood Cell count)
Description

WBC

Data type

text

Measurement units
  • 10*3/uL
Alias
UMLS CUI [1]
C0023508
10*3/uL
total neutrophils (Total ANC - Total Absolute Neutrophil Count)
Description

neutrophils

Data type

float

Measurement units
  • 10*3/uL
Alias
UMLS CUI [1]
C0948762
10*3/uL
lymphocytes
Description

lymphocytes

Data type

float

Measurement units
  • 10*3/uL
Alias
UMLS CUI [1]
C0200635
10*3/uL
monocytes
Description

monocytes

Data type

float

Measurement units
  • 10*3/uL
Alias
UMLS CUI [1]
C0200637
10*3/uL
eosinophils
Description

eosinophils

Data type

float

Measurement units
  • 10*3/uL
Alias
UMLS CUI [1]
C0200638
10*3/uL
basophils
Description

basophils

Data type

float

Measurement units
  • 10*3/uL
Alias
UMLS CUI [1]
C0200641
10*3/uL
MCV (Mean Corpuscle Volume)
Description

MCV

Data type

float

Measurement units
  • fL
Alias
UMLS CUI [1]
C1948043
fL
international normalised ratio (INR)
Description

INR

Data type

float

Alias
UMLS CUI [1]
C0525032
prothrombin time (PT)
Description

PT

Data type

integer

Alias
UMLS CUI [1]
C0033707
activated partial thromboplastin time (aPTT)
Description

aPTT

Data type

integer

Alias
UMLS CUI [1]
C0030605
Thrombopoietin
Description

Thrombopoietin

Data type

float

Measurement units
  • ng/L
Alias
UMLS CUI [1]
C2699935
ng/L
Liver Chemistry Assessments
Description

Liver Chemistry Assessments

Alias
UMLS CUI-1
C0232741
UMLS CUI-2
C0022885
Albumin
Description

Albumin

Data type

float

Measurement units
  • g/L
Alias
UMLS CUI [1]
C0201838
g/L
Serum creatine phosphokinase (CPK)
Description

CPK

Data type

float

Alias
UMLS CUI [1]
C0201973
Serum lactate dehydrogenase (LDH)
Description

LDH

Data type

float

Alias
UMLS CUI [1]
C0202113
Child Pugh Score
Description

Measure: Total bilirubin, Serum albumin, INR, Ascites, Hepatic encephalopathy

Data type

integer

Alias
UMLS CUI [1]
C4055253
Child-Pugh Class
Description

Child-Pugh Class A=score 5-6 Child-Pugh Class B=score 7-9

Data type

text

Alias
UMLS CUI [1]
C4050412
model for end-stage liver disease (MELD) score
Description

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.

Data type

float

Alias
UMLS CUI [1]
C1718072
Anti-nuclear antibody
Description

The following are required for subjects who meet the ALT and bilirubin threshold stopping criteria but are optional for other abnormal liver chemistries

Data type

float

Alias
UMLS CUI [1]
C0587178
anti-smooth muscle antibody
Description

anti-smooth muscle antibody

Data type

float

Alias
UMLS CUI [1]
C0201511
Type 1 anti-liver kidney microsomal antibodies
Description

Type 1 anti-liver kidney microsomal antibodies

Data type

float

Alias
UMLS CUI [1]
C0373868
Hepatitis A IgM antibody
Description

Hepatitis A IgM antibody

Data type

float

Alias
UMLS CUI [1]
C0373852
Hepatitis B surface antigen and Hepatitis B Core Antibody (IgM)
Description

Hepatitis B surface antigen and Hepatitis B Core Antibody (IgM)

Data type

float

Alias
UMLS CUI [1]
C0201477
UMLS CUI [2]
C0201480
Cytomegalovirus IgM antibody
Description

Cytomegalovirus IgM antibody

Data type

float

Alias
UMLS CUI [1]
C3272889
Epstein-Barr viral capsid antigen IgM antibody
Description

(or if unavailable, obtain heterophile antibody or monospot testing)

Data type

float

Alias
UMLS CUI [1]
C2732963
Hepatitis E IgM antibody
Description

(if subject resides outside the USA or Canada, or has travelled outside USA or Canada in past 3 months)

Data type

float

Alias
UMLS CUI [1]
C3272944
Renal Laboratory Parameters
Description

Renal Laboratory Parameters

Alias
UMLS CUI-1
C0232804
UMLS CUI-2
C0022885
Serum creatinine
Description

Serum creatinine

Data type

float

Measurement units
  • umol/L
Alias
UMLS CUI [1]
C0201976
umol/L
Creatinine clearance
Description

Creatinine clearance

Data type

integer

Measurement units
  • mL/min
Alias
UMLS CUI [1]
C2711451
mL/min
Urine protein/creatinine ratio (UP/CR)
Description

UP/CR

Data type

float

Alias
UMLS CUI [1]
C1096054
GFR
Description

GFR was calculated by the Cockcroft-Gault formula.

Data type

float

Alias
UMLS CUI [1]
C0017654
Microscopic Urine Analysis
Description

Microscopic Urine Analysis

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0205288
urine protein electrophoresis
Description

If the UP/CR is above the ULN, then a urine protein electrophoresis will also be performed

Data type

text

Alias
UMLS CUI [1]
C0201721
Urinalysis Dipstick
Description

Urinalysis Dipstick

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
UMLS CUI-3
C0022885
Urine Urobilinogen
Description

Urine Urobilinogen

Data type

float

Measurement units
  • umol/L
Alias
UMLS CUI [1]
C0427736
umol/L
Urine Protein
Description

Urine Protein

Data type

float

Measurement units
  • g/L
Alias
UMLS CUI [1]
C0262923
g/L
Urine Occult Blood
Description

Urine Occult Blood

Data type

integer

Measurement units
  • Ery/uL
Alias
UMLS CUI [1]
C2188744
UMLS CUI [2]
C0202514
Ery/uL
Urine Ketones
Description

Urine Ketones

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C1991100
mmol/L
Urine Bilirubin
Description

Urine Bilirubin

Data type

integer

Alias
UMLS CUI [1]
C0042040
Urine Glucose
Description

Urine Glucose

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0004076
mmol/L
Urine pH
Description

Urine pH

Data type

float

Alias
UMLS CUI [1]
C0042044
Urine Specific Gravity
Description

Urine Specific Gravity

Data type

float

Alias
UMLS CUI [1]
C0202517
Other Laboratory Screenings
Description

Other Laboratory Screenings

Alias
UMLS CUI-1
C0022885
HCV RNA Viral Load
Description

HCV RNA

Data type

float

Measurement units
  • [iU]/L
Alias
UMLS CUI [1]
C0369335
[iU]/L
Actual HVR RNA
Description

HVR RNA

Data type

float

Measurement units
  • [iU]/L
[iU]/L
HCV genotype
Description

HCV genotype 2/3 HCV genotype non 2/3

Data type

integer

Alias
UMLS CUI [1]
C1148363
Baseline fasting FibroTest/Acti Test (Fibrosure): HCV FibroSURE Score
Description

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).

Data type

integer

Alias
UMLS CUI [1,1]
C1954439
UMLS CUI [1,2]
C3642160
Necroinflammatory Activity (METAVIR) score
Description

Necroinflammatory Activity (METAVIR)

Data type

text

Alias
UMLS CUI [1]
C1954431
Hepatitis C Viral RNA quantitative transcription-mediated amplification (TMA)
Description

The Hepatitis C Viral RNA quantitative transcription-mediated amplification (TMA) was used to quantitate the level of HCV RNA in serum or plasma.

Data type

float

Measurement units
  • [iU]/L
Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
C1553166
[iU]/L
beta-human chorionic gonadotrophin (beta-hCG)
Description

A screening beta-human chorionic gonadotrophin (beta-hCG) pregnancy test was mandatory for all female subjects of childbearing potential per local standards

Data type

text

Alias
UMLS CUI [1]
C0430056
HIV screening test
Description

HIV screening

Data type

text

Alias
UMLS CUI [1]
C0019682

Similar models

Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Lab panels NCT00516321

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Chemistry
C2347783 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
ALT
Item
ALT
float
C0201836 (UMLS CUI [1])
AST
Item
AST
float
C0201899 (UMLS CUI [1])
Urea
Item
serum urea
float
C0523961 (UMLS CUI [1])
bicarbonate
Item
bicarbonate
float
C0202059 (UMLS CUI [1])
chloride
Item
chloride
float
C0201952 (UMLS CUI [1])
glucose
Item
glucose
float
C0202042 (UMLS CUI [1])
total bilirubin
Item
total bilirubin
float
C1278039 (UMLS CUI [1])
direct bilirubin
Item
direct bilirubin
float
C0201916 (UMLS CUI [1])
Indirect Bilirubin
Item
Indirect Bilirubin Levels
float
C1881193 (UMLS CUI [1])
uric acid
Item
uric acid
float
C0202239 (UMLS CUI [1])
blood urea nitrogen
Item
blood urea nitrogen
float
C0005845 (UMLS CUI [1])
sodium
Item
sodium
float
C0337443 (UMLS CUI [1])
potassium
Item
potassium
float
C0202194 (UMLS CUI [1])
calcium
Item
calcium
float
C0201925 (UMLS CUI [1])
magnesium
Item
magnesium
float
C0373675 (UMLS CUI [1])
phosphate
Item
phosphate
float
C0523826 (UMLS CUI [1])
total protein
Item
total protein
float
C0036836 (UMLS CUI [1])
Alpha-fetoprotein
Item
Alpha-fetoprotein
float
C0201539 (UMLS CUI [1])
Item Group
Haematology
C0474523 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Complete Blood Count
Item
Complete Blood Count
text
C0009555 (UMLS CUI [1])
red blood cell
Item
red blood cell count
float
C0014772 (UMLS CUI [1])
haemoglobin
Item
haemoglobin
float
C0518015 (UMLS CUI [1])
haematocrit
Item
haematocrit
float
C0018935 (UMLS CUI [1])
platelet count
Item
platelet count
float
C0005821 (UMLS CUI [1])
WBC
Item
WBC (White Blood Cell count)
text
C0023508 (UMLS CUI [1])
neutrophils
Item
total neutrophils (Total ANC - Total Absolute Neutrophil Count)
float
C0948762 (UMLS CUI [1])
lymphocytes
Item
lymphocytes
float
C0200635 (UMLS CUI [1])
monocytes
Item
monocytes
float
C0200637 (UMLS CUI [1])
eosinophils
Item
eosinophils
float
C0200638 (UMLS CUI [1])
basophils
Item
basophils
float
C0200641 (UMLS CUI [1])
MCV
Item
MCV (Mean Corpuscle Volume)
float
C1948043 (UMLS CUI [1])
INR
Item
international normalised ratio (INR)
float
C0525032 (UMLS CUI [1])
PT
Item
prothrombin time (PT)
integer
C0033707 (UMLS CUI [1])
aPTT
Item
activated partial thromboplastin time (aPTT)
integer
C0030605 (UMLS CUI [1])
Thrombopoietin
Item
Thrombopoietin
float
C2699935 (UMLS CUI [1])
Item Group
Liver Chemistry Assessments
C0232741 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
CPK
Item
Serum creatine phosphokinase (CPK)
float
C0201973 (UMLS CUI [1])
LDH
Item
Serum lactate dehydrogenase (LDH)
float
C0202113 (UMLS CUI [1])
Child Pugh Score
Item
Child Pugh Score
integer
C4055253 (UMLS CUI [1])
Item
Child-Pugh Class
text
C4050412 (UMLS CUI [1])
Code List
Child-Pugh Class
CL Item
Class A (A)
CL Item
Class B (B)
CL Item
Class C (N)
MELD score
Item
model for end-stage liver disease (MELD) score
float
C1718072 (UMLS CUI [1])
Anti-nuclear antibody
Item
Anti-nuclear antibody
float
C0587178 (UMLS CUI [1])
anti-smooth muscle antibody
Item
anti-smooth muscle antibody
float
C0201511 (UMLS CUI [1])
Type 1 anti-liver kidney microsomal antibodies
Item
Type 1 anti-liver kidney microsomal antibodies
float
C0373868 (UMLS CUI [1])
Hepatitis A IgM antibody
Item
Hepatitis A IgM antibody
float
C0373852 (UMLS CUI [1])
Hepatitis B surface antigen and Hepatitis B Core Antibody (IgM)
Item
Hepatitis B surface antigen and Hepatitis B Core Antibody (IgM)
float
C0201477 (UMLS CUI [1])
C0201480 (UMLS CUI [2])
Cytomegalovirus IgM antibody
Item
Cytomegalovirus IgM antibody
float
C3272889 (UMLS CUI [1])
Epstein-Barr viral capsid antigen IgM antibody
Item
Epstein-Barr viral capsid antigen IgM antibody
float
C2732963 (UMLS CUI [1])
Hepatitis E IgM antibody
Item
Hepatitis E IgM antibody
float
C3272944 (UMLS CUI [1])
Item Group
Renal Laboratory Parameters
C0232804 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Serum creatinine
Item
Serum creatinine
float
C0201976 (UMLS CUI [1])
Creatinine clearance
Item
Creatinine clearance
integer
C2711451 (UMLS CUI [1])
UP/CR
Item
Urine protein/creatinine ratio (UP/CR)
float
C1096054 (UMLS CUI [1])
GFR
Item
GFR
float
C0017654 (UMLS CUI [1])
Microscopic Urine Analysis
Item
Microscopic Urine Analysis
text
C0042014 (UMLS CUI [1,1])
C0205288 (UMLS CUI [1,2])
urine protein electrophoresis
Item
urine protein electrophoresis
text
C0201721 (UMLS CUI [1])
Item Group
Urinalysis Dipstick
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
Urine Urobilinogen
Item
Urine Urobilinogen
float
C0427736 (UMLS CUI [1])
Urine Protein
Item
Urine Protein
float
C0262923 (UMLS CUI [1])
Urine Occult Blood
Item
Urine Occult Blood
integer
C2188744 (UMLS CUI [1])
C0202514 (UMLS CUI [2])
Urine Ketones
Item
Urine Ketones
float
C1991100 (UMLS CUI [1])
Item
Urine Bilirubin
integer
C0042040 (UMLS CUI [1])
Code List
Urine Bilirubin
CL Item
negativ (-) (1)
CL Item
positive (+) (2)
CL Item
++ (3)
CL Item
+++ (4)
Urine Glucose
Item
Urine Glucose
float
C0004076 (UMLS CUI [1])
Urine pH
Item
Urine pH
float
C0042044 (UMLS CUI [1])
Urine Specific Gravity
Item
Urine Specific Gravity
float
C0202517 (UMLS CUI [1])
Item Group
Other Laboratory Screenings
C0022885 (UMLS CUI-1)
HCV RNA
Item
HCV RNA Viral Load
float
C0369335 (UMLS CUI [1])
HVR RNA
Item
Actual HVR RNA
float
Item
HCV genotype
integer
C1148363 (UMLS CUI [1])
Code List
HCV genotype
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
6 (6)
CL Item
0 (0)
Item
Baseline fasting FibroTest/Acti Test (Fibrosure): HCV FibroSURE Score
integer
C1954439 (UMLS CUI [1,1])
C3642160 (UMLS CUI [1,2])
Code List
Baseline fasting FibroTest/Acti Test (Fibrosure): HCV FibroSURE Score
CL Item
0/1/2 (1)
CL Item
3/4 (2)
Item
Necroinflammatory Activity (METAVIR) score
text
C1954431 (UMLS CUI [1])
Code List
Necroinflammatory Activity (METAVIR) score
CL Item
no activity (A0)
CL Item
A1-minimal activity (A1-minimal activity)
CL Item
moderate activity (A2)
CL Item
severe activity (A3)
TMA
Item
Hepatitis C Viral RNA quantitative transcription-mediated amplification (TMA)
float
C0369335 (UMLS CUI [1,1])
C1553166 (UMLS CUI [1,2])
beta-human chorionic gonadotrophin
Item
beta-human chorionic gonadotrophin (beta-hCG)
text
C0430056 (UMLS CUI [1])
HIV screening
Item
HIV screening test
text
C0019682 (UMLS CUI [1])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial