ID

43969

Description

The purpose of this study is to test the safety and tolerability of eltrombopag when used to increase and maintain platelet count. Platelet count to be maintained at a level sufficient to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions, and to avoid permanent discontinuation of antiviral therapy. NCT00996216 https://clinicaltrials.gov/ct2/show/NCT00996216 Study Type: Interventional Study Design: Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: An Open-label, Multi-centre Rollover Study to Assess the Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a or Peginterferon Alfa-2b Plus Ribavirin)

Link

https://clinicaltrials.gov/ct2/show/NCT00996216

Keywords

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

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Infection Lab panels NCT00996216

English

Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Infection Lab panels NCT00996216

1 forms  
Clinical Chemistry
Description

Clinical 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
AST
Description

AST

Data type

float

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

Urea

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0523961
mmol/L
bicarbonate/CO2
Description

bicarbonate/CO2

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
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
total albumin
Description

albumin

Data type

float

Measurement units
  • g/L
Alias
UMLS CUI [1]
C0201838
g/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
uric acid
Description

uric acid

Data type

float

Measurement units
  • umol/L
Alias
UMLS CUI [1]
C0202239
umol/L
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

Alias
UMLS CUI [1]
C0005821
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
Coagulation Assay (INR)
Description

INR

Data type

float

Alias
UMLS CUI [1]
C0525032
Liver Chemistry
Description

Liver Chemistry

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

ALT

Data type

float

Measurement units
  • [iU]/L
Alias
UMLS CUI [1]
C0201836
[iU]/L
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 (excluded from this Protocol) Child-Pugh Class C=score >9 (excluded from this Protocol)

Data type

text

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

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
Renal Assessments
Description

Renal Assessments

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

determined by the Cockcroft- Gault formula

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

Measurement units
  • mg/mg
Alias
UMLS CUI [1]
C1096054
mg/mg
GFR
Description

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.

Data type

float

Alias
UMLS CUI [1]
C0017654
Microscopic Urine Analysis
Description

if required

Data type

text

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

if required

Data type

text

Alias
UMLS CUI [1]
C0201721
urine electrolytes
Description

if required

Data type

text

Alias
UMLS CUI [1]
C0587362
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
Description

in LOG IU/ML Summary of Log-Transformed HCV RNA (LOG IU/ML) at Baseline (Pre-antiviral Safety Population)

Data type

float

Measurement units
  • [lg] [iU]/mL
Alias
UMLS CUI [1]
C0369335
[lg] [iU]/mL
HCV genotype
Description

HCV genotype

Data type

text

Alias
UMLS CUI [1]
C1148363
HIV screening test
Description

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.

Data type

text

Alias
UMLS CUI [1]
C0019682
Hepatitis B Screening
Description

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.

Data type

text

Alias
UMLS CUI [1]
C1278302
urine beta-hCG test
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
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Similar models

Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Infection Lab panels NCT00996216

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Clinical Chemistry
C2347783 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
AST
Item
AST
float
C0201899 (UMLS CUI [1])
Urea
Item
Urea
float
C0523961 (UMLS CUI [1])
bicarbonate/CO2
Item
bicarbonate/CO2
float
C0202059 (UMLS CUI [1])
chloride
Item
chloride
float
C0201952 (UMLS CUI [1])
glucose
Item
glucose
float
C0202042 (UMLS CUI [1])
sodium
Item
sodium
float
C0337443 (UMLS CUI [1])
potassium
Item
potassium
float
C0202194 (UMLS CUI [1])
albumin
Item
total albumin
float
C0201838 (UMLS CUI [1])
total bilirubin
Item
total bilirubin
float
C1278039 (UMLS CUI [1])
direct bilirubin
Item
direct bilirubin
float
C0201916 (UMLS CUI [1])
uric acid
Item
uric acid
float
C0202239 (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
Coagulation Assay (INR)
float
C0525032 (UMLS CUI [1])
Item Group
Liver Chemistry
C0232741 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
ALT
Item
ALT
float
C0201836 (UMLS CUI [1])
Child Pugh Score
Item
Child Pugh Score
integer
C4055253 (UMLS CUI [1])
Item
Child-Pugh Class
text
C4050412 (UMLS CUI [1])
Child-Pugh Class
Code List
Child-Pugh Class
CL Item
Class A (A)
CL Item
Class B (B)
CL Item
Class C (C)
MELD score
Item
model for end-stage liver disease (MELD) score
float
C1718072 (UMLS CUI [1])
Item Group
Renal Assessments
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])
urine electrolytes
Item
urine electrolytes
text
C0587362 (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])
Urine Bilirubin
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
float
C0369335 (UMLS CUI [1])
HCV genotype
Item
HCV genotype
text
C1148363 (UMLS CUI [1])
HIV screening
Item
HIV screening test
text
C0019682 (UMLS CUI [1])
Hepatitis B Screening
Item
Hepatitis B Screening
text
C1278302 (UMLS CUI [1])
beta-human chorionic gonadotrophin
Item
urine beta-hCG test
text
C0430056 (UMLS CUI [1])
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