ID
43969
Beschrijving
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
Trefwoorden
Versies (2)
- 31-05-17 31-05-17 -
- 20-09-21 20-09-21 -
Geüploaded op
20 september 2021
DOI
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Licentie
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
Beschrijving
Haematology
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C0022885
Beschrijving
Complete Blood Count
Datatype
text
Alias
- UMLS CUI [1]
- C0009555
Beschrijving
red blood cell
Datatype
float
Maateenheden
- 10*6/uL
Alias
- UMLS CUI [1]
- C0014772
Beschrijving
haemoglobin
Datatype
float
Maateenheden
- g/L
Alias
- UMLS CUI [1]
- C0518015
Beschrijving
haematocrit
Datatype
float
Alias
- UMLS CUI [1]
- C0018935
Beschrijving
platelet count
Datatype
float
Alias
- UMLS CUI [1]
- C0005821
Beschrijving
WBC
Datatype
text
Maateenheden
- 10*3/uL
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
neutrophils
Datatype
float
Maateenheden
- 10*3/uL
Alias
- UMLS CUI [1]
- C0948762
Beschrijving
lymphocytes
Datatype
float
Maateenheden
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200635
Beschrijving
monocytes
Datatype
float
Maateenheden
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200637
Beschrijving
eosinophils
Datatype
float
Maateenheden
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200638
Beschrijving
basophils
Datatype
float
Maateenheden
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200641
Beschrijving
MCV
Datatype
float
Maateenheden
- fL
Alias
- UMLS CUI [1]
- C1948043
Beschrijving
INR
Datatype
float
Alias
- UMLS CUI [1]
- C0525032
Beschrijving
Liver Chemistry
Alias
- UMLS CUI-1
- C0232741
- UMLS CUI-2
- C0022885
Beschrijving
ALT
Datatype
float
Maateenheden
- [iU]/L
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
Measure: Total bilirubin, Serum albumin, INR, Ascites, Hepatic encephalopathy
Datatype
integer
Alias
- UMLS CUI [1]
- C4055253
Beschrijving
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)
Datatype
text
Alias
- UMLS CUI [1]
- C4050412
Beschrijving
MELD Score = 3.78 * {ln [serum bilirubin (mg/dL)]} + 11.2 *{ln[INR]} + 9.57*{ln[serum creatinine (mg/dL)]} + 6.43.
Datatype
float
Alias
- UMLS CUI [1]
- C1718072
Beschrijving
Renal Assessments
Alias
- UMLS CUI-1
- C0232804
- UMLS CUI-2
- C0022885
Beschrijving
Serum creatinine
Datatype
float
Maateenheden
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
determined by the Cockcroft- Gault formula
Datatype
integer
Maateenheden
- mL/min
Alias
- UMLS CUI [1]
- C2711451
Beschrijving
UP/CR
Datatype
float
Maateenheden
- mg/mg
Alias
- UMLS CUI [1]
- C1096054
Beschrijving
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.
Datatype
float
Alias
- UMLS CUI [1]
- C0017654
Beschrijving
if required
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205288
Beschrijving
if required
Datatype
text
Alias
- UMLS CUI [1]
- C0201721
Beschrijving
if required
Datatype
text
Alias
- UMLS CUI [1]
- C0587362
Beschrijving
Urinalysis Dipstick
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C0022885
Beschrijving
Urine Urobilinogen
Datatype
float
Maateenheden
- umol/L
Alias
- UMLS CUI [1]
- C0427736
Beschrijving
Urine Protein
Datatype
float
Maateenheden
- g/L
Alias
- UMLS CUI [1]
- C0262923
Beschrijving
Urine Occult Blood
Datatype
integer
Maateenheden
- Ery/uL
Alias
- UMLS CUI [1]
- C2188744
- UMLS CUI [2]
- C0202514
Beschrijving
Urine Ketones
Datatype
float
Maateenheden
- mmol/L
Alias
- UMLS CUI [1]
- C1991100
Beschrijving
Urine Bilirubin
Datatype
integer
Alias
- UMLS CUI [1]
- C0042040
Beschrijving
Urine Glucose
Datatype
float
Maateenheden
- mmol/L
Alias
- UMLS CUI [1]
- C0004076
Beschrijving
Urine pH
Datatype
float
Alias
- UMLS CUI [1]
- C0042044
Beschrijving
Urine Specific Gravity
Datatype
float
Alias
- UMLS CUI [1]
- C0202517
Beschrijving
Other Laboratory Screenings
Alias
- UMLS CUI-1
- C0022885
Beschrijving
in LOG IU/ML Summary of Log-Transformed HCV RNA (LOG IU/ML) at Baseline (Pre-antiviral Safety Population)
Datatype
float
Maateenheden
- [lg] [iU]/mL
Alias
- UMLS CUI [1]
- C0369335
Beschrijving
HCV genotype
Datatype
text
Alias
- UMLS CUI [1]
- C1148363
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1]
- C0019682
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1]
- C1278302
Beschrijving
A screening beta-human chorionic gonadotrophin (beta-hCG) pregnancy test was mandatory for all female subjects of childbearing potential per local standards
Datatype
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])