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)
- 31.05.17 31.05.17 -
- 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.
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
Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Infection Lab panels NCT00996216
Beschreibung
Haematology
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C0022885
Beschreibung
Complete Blood Count
Datentyp
text
Alias
- UMLS CUI [1]
- C0009555
Beschreibung
red blood cell
Datentyp
float
Maßeinheiten
- 10*6/uL
Alias
- UMLS CUI [1]
- C0014772
Beschreibung
haemoglobin
Datentyp
float
Maßeinheiten
- g/L
Alias
- UMLS CUI [1]
- C0518015
Beschreibung
haematocrit
Datentyp
float
Alias
- UMLS CUI [1]
- C0018935
Beschreibung
platelet count
Datentyp
float
Alias
- UMLS CUI [1]
- C0005821
Beschreibung
WBC
Datentyp
text
Maßeinheiten
- 10*3/uL
Alias
- UMLS CUI [1]
- C0023508
Beschreibung
neutrophils
Datentyp
float
Maßeinheiten
- 10*3/uL
Alias
- UMLS CUI [1]
- C0948762
Beschreibung
lymphocytes
Datentyp
float
Maßeinheiten
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200635
Beschreibung
monocytes
Datentyp
float
Maßeinheiten
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200637
Beschreibung
eosinophils
Datentyp
float
Maßeinheiten
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200638
Beschreibung
basophils
Datentyp
float
Maßeinheiten
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200641
Beschreibung
MCV
Datentyp
float
Maßeinheiten
- fL
Alias
- UMLS CUI [1]
- C1948043
Beschreibung
INR
Datentyp
float
Alias
- UMLS CUI [1]
- C0525032
Beschreibung
Liver Chemistry
Alias
- UMLS CUI-1
- C0232741
- UMLS CUI-2
- C0022885
Beschreibung
ALT
Datentyp
float
Maßeinheiten
- [iU]/L
Alias
- UMLS CUI [1]
- C0201836
Beschreibung
Measure: Total bilirubin, Serum albumin, INR, Ascites, Hepatic encephalopathy
Datentyp
integer
Alias
- UMLS CUI [1]
- C4055253
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
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
Beschreibung
Renal Assessments
Alias
- UMLS CUI-1
- C0232804
- UMLS CUI-2
- C0022885
Beschreibung
Serum creatinine
Datentyp
float
Maßeinheiten
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
determined by the Cockcroft- Gault formula
Datentyp
integer
Maßeinheiten
- mL/min
Alias
- UMLS CUI [1]
- C2711451
Beschreibung
UP/CR
Datentyp
float
Maßeinheiten
- mg/mg
Alias
- UMLS CUI [1]
- C1096054
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
Beschreibung
if required
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205288
Beschreibung
if required
Datentyp
text
Alias
- UMLS CUI [1]
- C0201721
Beschreibung
if required
Datentyp
text
Alias
- UMLS CUI [1]
- C0587362
Beschreibung
Urinalysis Dipstick
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C0022885
Beschreibung
Urine Urobilinogen
Datentyp
float
Maßeinheiten
- umol/L
Alias
- UMLS CUI [1]
- C0427736
Beschreibung
Urine Protein
Datentyp
float
Maßeinheiten
- g/L
Alias
- UMLS CUI [1]
- C0262923
Beschreibung
Urine Occult Blood
Datentyp
integer
Maßeinheiten
- Ery/uL
Alias
- UMLS CUI [1]
- C2188744
- UMLS CUI [2]
- C0202514
Beschreibung
Urine Ketones
Datentyp
float
Maßeinheiten
- mmol/L
Alias
- UMLS CUI [1]
- C1991100
Beschreibung
Urine Bilirubin
Datentyp
integer
Alias
- UMLS CUI [1]
- C0042040
Beschreibung
Urine Glucose
Datentyp
float
Maßeinheiten
- mmol/L
Alias
- UMLS CUI [1]
- C0004076
Beschreibung
Urine pH
Datentyp
float
Alias
- UMLS CUI [1]
- C0042044
Beschreibung
Urine Specific Gravity
Datentyp
float
Alias
- UMLS CUI [1]
- C0202517
Beschreibung
Other Laboratory Screenings
Alias
- UMLS CUI-1
- C0022885
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
Beschreibung
HCV genotype
Datentyp
text
Alias
- UMLS CUI [1]
- C1148363
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
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
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
Ähnliche Modelle
Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Infection Lab panels NCT00996216
C0205288 (UMLS CUI [1,2])
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0202514 (UMLS CUI [2])