ID

22363

Beschreibung

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

Stichworte

Versionen (2)
  1. 31.05.17 31.05.17 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

31. Mai 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

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

Englisch

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

1 Formulare  
Clinical Chemistry
Beschreibung

Clinical Chemistry

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

Alkaline phosphatase

Datentyp

float

Maßeinheiten
  • [iU]/L
Alias
UMLS CUI [1]
C0201850
[iU]/L
AST
Beschreibung

AST

Datentyp

float

Maßeinheiten
  • [iU]/L
Alias
UMLS CUI [1]
C0201899
[iU]/L
Urea
Beschreibung

Urea

Datentyp

float

Maßeinheiten
  • mmol/L
Alias
UMLS CUI [1]
C0523961
mmol/L
bicarbonate/CO2
Beschreibung

bicarbonate/CO2

Datentyp

float

Maßeinheiten
  • mmol/L
Alias
UMLS CUI [1]
C0202059
mmol/L
chloride
Beschreibung

chloride

Datentyp

float

Maßeinheiten
  • mmol/L
Alias
UMLS CUI [1]
C0201952
mmol/L
glucose
Beschreibung

glucose

Datentyp

float

Maßeinheiten
  • mmol/L
Alias
UMLS CUI [1]
C0202042
mmol/L
sodium
Beschreibung

sodium

Datentyp

float

Maßeinheiten
  • mmol/L
Alias
UMLS CUI [1]
C0337443
mmol/L
potassium
Beschreibung

potassium

Datentyp

float

Maßeinheiten
  • mmol/L
Alias
UMLS CUI [1]
C0202194
mmol/L
total albumin
Beschreibung

albumin

Datentyp

float

Maßeinheiten
  • g/L
Alias
UMLS CUI [1]
C0201838
g/L
total bilirubin
Beschreibung

total bilirubin

Datentyp

float

Maßeinheiten
  • umol/L
Alias
UMLS CUI [1]
C1278039
umol/L
direct bilirubin
Beschreibung

direct bilirubin

Datentyp

float

Maßeinheiten
  • umol/L
Alias
UMLS CUI [1]
C0201916
umol/L
uric acid
Beschreibung

uric acid

Datentyp

float

Maßeinheiten
  • umol/L
Alias
UMLS CUI [1]
C0202239
umol/L
Haematology
Beschreibung

Haematology

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

Complete Blood Count

Datentyp

text

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

red blood cell

Datentyp

float

Maßeinheiten
  • 10*6/uL
Alias
UMLS CUI [1]
C0014772
10*6/uL
haemoglobin
Beschreibung

haemoglobin

Datentyp

float

Maßeinheiten
  • g/L
Alias
UMLS CUI [1]
C0518015
g/L
haematocrit
Beschreibung

haematocrit

Datentyp

float

Alias
UMLS CUI [1]
C0018935
platelet count
Beschreibung

platelet count

Datentyp

float

Alias
UMLS CUI [1]
C0005821
WBC (White Blood Cell count)
Beschreibung

WBC

Datentyp

text

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

neutrophils

Datentyp

float

Maßeinheiten
  • 10*3/uL
Alias
UMLS CUI [1]
C0948762
10*3/uL
lymphocytes
Beschreibung

lymphocytes

Datentyp

float

Maßeinheiten
  • 10*3/uL
Alias
UMLS CUI [1]
C0200635
10*3/uL
monocytes
Beschreibung

monocytes

Datentyp

float

Maßeinheiten
  • 10*3/uL
Alias
UMLS CUI [1]
C0200637
10*3/uL
eosinophils
Beschreibung

eosinophils

Datentyp

float

Maßeinheiten
  • 10*3/uL
Alias
UMLS CUI [1]
C0200638
10*3/uL
basophils
Beschreibung

basophils

Datentyp

float

Maßeinheiten
  • 10*3/uL
Alias
UMLS CUI [1]
C0200641
10*3/uL
MCV (Mean Corpuscle Volume)
Beschreibung

MCV

Datentyp

float

Maßeinheiten
  • fL
Alias
UMLS CUI [1]
C1948043
fL
Coagulation Assay (INR)
Beschreibung

INR

Datentyp

float

Alias
UMLS CUI [1]
C0525032
Liver Chemistry
Beschreibung

Liver Chemistry

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

ALT

Datentyp

float

Maßeinheiten
  • [iU]/L
Alias
UMLS CUI [1]
C0201836
[iU]/L
Child Pugh Score
Beschreibung

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

Datentyp

integer

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

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)

Datentyp

text

Alias
UMLS CUI [1]
C2347612
model for end-stage liver disease (MELD) score
Beschreibung

MELD Score = 3.78 * {ln [serum bilirubin (mg/dL)]} + 11.2 *{ln[INR]} + 9.57*{ln[serum creatinine (mg/dL)]} + 6.43.

Datentyp

float

Alias
UMLS CUI [1]
C1718072
Renal Assessments
Beschreibung

Renal Assessments

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

Serum creatinine

Datentyp

float

Maßeinheiten
  • umol/L
Alias
UMLS CUI [1]
C0201976
umol/L
Creatinine clearance
Beschreibung

determined by the Cockcroft- Gault formula

Datentyp

integer

Maßeinheiten
  • mL/min
Alias
UMLS CUI [1]
C2711451
mL/min
Urine protein/creatinine ratio (UP/CR)
Beschreibung

UP/CR

Datentyp

float

Maßeinheiten
  • mg/mg
Alias
UMLS CUI [1]
C1096054
mg/mg
GFR
Beschreibung

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.

Datentyp

float

Alias
UMLS CUI [1]
C0017654
Microscopic Urine Analysis
Beschreibung

if required

Datentyp

text

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

if required

Datentyp

text

Alias
UMLS CUI [1]
C0201721
urine electrolytes
Beschreibung

if required

Datentyp

text

Alias
UMLS CUI [1]
C0587362
Urinalysis Dipstick
Beschreibung

Urinalysis Dipstick

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

Urine Urobilinogen

Datentyp

float

Maßeinheiten
  • umol/L
Alias
UMLS CUI [1]
C0427736
umol/L
Urine Protein
Beschreibung

Urine Protein

Datentyp

float

Maßeinheiten
  • g/L
Alias
UMLS CUI [1]
C0262923
g/L
Urine Occult Blood
Beschreibung

Urine Occult Blood

Datentyp

integer

Maßeinheiten
  • Ery/uL
Alias
UMLS CUI [1]
C2188744
UMLS CUI [2]
C0202514
Ery/uL
Urine Ketones
Beschreibung

Urine Ketones

Datentyp

float

Maßeinheiten
  • mmol/L
Alias
UMLS CUI [1]
C1991100
mmol/L
Urine Bilirubin
Beschreibung

Urine Bilirubin

Datentyp

integer

Alias
UMLS CUI [1]
C0042040
Urine Glucose
Beschreibung

Urine Glucose

Datentyp

float

Maßeinheiten
  • mmol/L
Alias
UMLS CUI [1]
C0004076
mmol/L
Urine pH
Beschreibung

Urine pH

Datentyp

float

Alias
UMLS CUI [1]
C0042044
Urine Specific Gravity
Beschreibung

Urine Specific Gravity

Datentyp

float

Alias
UMLS CUI [1]
C0202517
Other Laboratory Screenings
Beschreibung

Other Laboratory Screenings

Alias
UMLS CUI-1
C0022885
HCV RNA
Beschreibung

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

Datentyp

float

Maßeinheiten
  • [lg] [iU]/mL
Alias
UMLS CUI [1]
C0369335
[lg] [iU]/mL
HCV genotype
Beschreibung

HCV genotype

Datentyp

text

Alias
UMLS CUI [1]
C1148363
HIV screening test
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1]
C0019682
Hepatitis B Screening
Beschreibung

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.

Datentyp

text

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

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

Datentyp

text

Alias
UMLS CUI [1]
C0430056
Zum Seitenanfang zurückkehren

Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
C2347612 (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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video