ID
43969
Beskrivning
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)
Länk
https://clinicaltrials.gov/ct2/show/NCT00996216
Nyckelord
Versioner (2)
- 2017-05-31 2017-05-31 -
- 2021-09-20 2021-09-20 -
Uppladdad den
20 september 2021
DOI
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Licens
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
Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Infection Lab panels NCT00996216
Beskrivning
Haematology
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C0022885
Beskrivning
Complete Blood Count
Datatyp
text
Alias
- UMLS CUI [1]
- C0009555
Beskrivning
red blood cell
Datatyp
float
Måttenheter
- 10*6/uL
Alias
- UMLS CUI [1]
- C0014772
Beskrivning
haemoglobin
Datatyp
float
Måttenheter
- g/L
Alias
- UMLS CUI [1]
- C0518015
Beskrivning
haematocrit
Datatyp
float
Alias
- UMLS CUI [1]
- C0018935
Beskrivning
platelet count
Datatyp
float
Alias
- UMLS CUI [1]
- C0005821
Beskrivning
WBC
Datatyp
text
Måttenheter
- 10*3/uL
Alias
- UMLS CUI [1]
- C0023508
Beskrivning
neutrophils
Datatyp
float
Måttenheter
- 10*3/uL
Alias
- UMLS CUI [1]
- C0948762
Beskrivning
lymphocytes
Datatyp
float
Måttenheter
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200635
Beskrivning
monocytes
Datatyp
float
Måttenheter
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200637
Beskrivning
eosinophils
Datatyp
float
Måttenheter
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200638
Beskrivning
basophils
Datatyp
float
Måttenheter
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200641
Beskrivning
MCV
Datatyp
float
Måttenheter
- fL
Alias
- UMLS CUI [1]
- C1948043
Beskrivning
INR
Datatyp
float
Alias
- UMLS CUI [1]
- C0525032
Beskrivning
Liver Chemistry
Alias
- UMLS CUI-1
- C0232741
- UMLS CUI-2
- C0022885
Beskrivning
ALT
Datatyp
float
Måttenheter
- [iU]/L
Alias
- UMLS CUI [1]
- C0201836
Beskrivning
Measure: Total bilirubin, Serum albumin, INR, Ascites, Hepatic encephalopathy
Datatyp
integer
Alias
- UMLS CUI [1]
- C4055253
Beskrivning
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)
Datatyp
text
Alias
- UMLS CUI [1]
- C4050412
Beskrivning
MELD Score = 3.78 * {ln [serum bilirubin (mg/dL)]} + 11.2 *{ln[INR]} + 9.57*{ln[serum creatinine (mg/dL)]} + 6.43.
Datatyp
float
Alias
- UMLS CUI [1]
- C1718072
Beskrivning
Renal Assessments
Alias
- UMLS CUI-1
- C0232804
- UMLS CUI-2
- C0022885
Beskrivning
Serum creatinine
Datatyp
float
Måttenheter
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Beskrivning
determined by the Cockcroft- Gault formula
Datatyp
integer
Måttenheter
- mL/min
Alias
- UMLS CUI [1]
- C2711451
Beskrivning
UP/CR
Datatyp
float
Måttenheter
- mg/mg
Alias
- UMLS CUI [1]
- C1096054
Beskrivning
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.
Datatyp
float
Alias
- UMLS CUI [1]
- C0017654
Beskrivning
if required
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205288
Beskrivning
if required
Datatyp
text
Alias
- UMLS CUI [1]
- C0201721
Beskrivning
if required
Datatyp
text
Alias
- UMLS CUI [1]
- C0587362
Beskrivning
Urinalysis Dipstick
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C0022885
Beskrivning
Urine Urobilinogen
Datatyp
float
Måttenheter
- umol/L
Alias
- UMLS CUI [1]
- C0427736
Beskrivning
Urine Protein
Datatyp
float
Måttenheter
- g/L
Alias
- UMLS CUI [1]
- C0262923
Beskrivning
Urine Occult Blood
Datatyp
integer
Måttenheter
- Ery/uL
Alias
- UMLS CUI [1]
- C2188744
- UMLS CUI [2]
- C0202514
Beskrivning
Urine Ketones
Datatyp
float
Måttenheter
- mmol/L
Alias
- UMLS CUI [1]
- C1991100
Beskrivning
Urine Bilirubin
Datatyp
integer
Alias
- UMLS CUI [1]
- C0042040
Beskrivning
Urine Glucose
Datatyp
float
Måttenheter
- mmol/L
Alias
- UMLS CUI [1]
- C0004076
Beskrivning
Urine pH
Datatyp
float
Alias
- UMLS CUI [1]
- C0042044
Beskrivning
Urine Specific Gravity
Datatyp
float
Alias
- UMLS CUI [1]
- C0202517
Beskrivning
Other Laboratory Screenings
Alias
- UMLS CUI-1
- C0022885
Beskrivning
in LOG IU/ML Summary of Log-Transformed HCV RNA (LOG IU/ML) at Baseline (Pre-antiviral Safety Population)
Datatyp
float
Måttenheter
- [lg] [iU]/mL
Alias
- UMLS CUI [1]
- C0369335
Beskrivning
HCV genotype
Datatyp
text
Alias
- UMLS CUI [1]
- C1148363
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1]
- C0019682
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1]
- C1278302
Beskrivning
A screening beta-human chorionic gonadotrophin (beta-hCG) pregnancy test was mandatory for all female subjects of childbearing potential per local standards
Datatyp
text
Alias
- UMLS CUI [1]
- C0430056
Similar models
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])