ID
43966
Beskrivning
The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR). NCT00529568 https://clinicaltrials.gov/ct2/show/NCT00529568 Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment Official Title: Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2b Plus Ribavirin)
Länk
https://clinicaltrials.gov/ct2/show/NCT00529568
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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Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Lab Panels NCT00529568
Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Lab Panels NCT00529568
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
Måttenheter
- 10*3/uL
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
PT
Datatyp
float
Måttenheter
- s
Alias
- UMLS CUI [1]
- C0033707
Beskrivning
aPTT
Datatyp
float
Måttenheter
- s
Alias
- UMLS CUI [1]
- C0030605
Beskrivning
Thrombopoietin
Datatyp
float
Måttenheter
- ng/L
Alias
- UMLS CUI [1]
- C2699935
Beskrivning
Liver Chemistry Assessments
Alias
- UMLS CUI-1
- C0232741
- UMLS CUI-2
- C0022885
Beskrivning
CPK
Datatyp
float
Måttenheter
- ug/L
Alias
- UMLS CUI [1]
- C0201973
Beskrivning
LDH
Datatyp
float
Måttenheter
- [iU]/L
Alias
- UMLS CUI [1]
- C0202113
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
Datatyp
text
Alias
- UMLS CUI [1]
- C4050412
Beskrivning
The Model for End-Stage Liver Disease (MELD) score is a function of serum bilirubin, serum creatinine, and the INR for prothrombin time. 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
The following are required for subjects who meet the ALT and bilirubin threshold stopping criteria but are optional for other abnormal liver chemistries
Datatyp
float
Alias
- UMLS CUI [1]
- C0587178
Beskrivning
anti-smooth muscle antibody
Datatyp
float
Alias
- UMLS CUI [1]
- C0201511
Beskrivning
Type 1 anti-liver kidney microsomal antibodies
Datatyp
float
Alias
- UMLS CUI [1]
- C0373868
Beskrivning
Hepatitis A IgM antibody
Datatyp
float
Alias
- UMLS CUI [1]
- C0373852
Beskrivning
Hepatitis B surface antigen and Hepatitis B Core Antibody (IgM)
Datatyp
float
Alias
- UMLS CUI [1]
- C0201477
- UMLS CUI [2]
- C0201480
Beskrivning
Cytomegalovirus IgM antibody
Datatyp
float
Alias
- UMLS CUI [1]
- C3272889
Beskrivning
(or if unavailable, obtain heterophile antibody or monospot testing)
Datatyp
float
Alias
- UMLS CUI [1]
- C2732963
Beskrivning
(if subject resides outside the USA or Canada, or has travelled outside USA or Canada in past 3 months)
Datatyp
float
Alias
- UMLS CUI [1]
- C3272944
Beskrivning
Renal Laboratory Parameters
Alias
- UMLS CUI-1
- C0232804
- UMLS CUI-2
- C0022885
Beskrivning
Serum creatinine
Datatyp
float
Måttenheter
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Beskrivning
Creatinine clearance
Datatyp
integer
Måttenheter
- mL/min
Alias
- UMLS CUI [1]
- C2711451
Beskrivning
UP/CR
Datatyp
float
Alias
- UMLS CUI [1]
- C1096054
Beskrivning
GFR was calculated by the Cockcroft-Gault formula.
Datatyp
float
Alias
- UMLS CUI [1]
- C0017654
Beskrivning
Microscopic Urine Analysis
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205288
Beskrivning
If the UP/CR is above the ULN, then a urine protein electrophoresis will also be performed
Datatyp
text
Alias
- UMLS CUI [1]
- C0201721
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
- {rbc}/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
HCV RNA
Datatyp
float
Måttenheter
- [iU]/mL
Alias
- UMLS CUI [1]
- C0369335
Beskrivning
HVR RNA
Datatyp
float
Måttenheter
- [iU]/mL
Beskrivning
HCV genotype 2/3 HCV genotype non 2/3
Datatyp
integer
Alias
- UMLS CUI [1]
- C1148363
Beskrivning
HCV FibroSURE is a noninvasive blood test that combines the quanitative results of 6 serum biochemical markers (α2-macroglobulin,haptoglobin, apolipoprotein A1, bilirubin, γ-glutamyl transpeptidase (GGT), and ALT), with a subject’s age and gender to generate a measure of fibrosis/cirrhosis and necroinflammatory activity in the liver. It provides a numerical quantitative estimate of liver fibrosis ranging from 0.00 to 1.00 corresponding the the Metavir scoring system of stages F0 to F4 (F0=no fibrosis, F1=portal fibrosis, F2=bridging fibrosis with few septa, F3=bridging fibrosis with many septa, F4=cirrhosis). The test also provides a numerical quantitative estimate of necroinflammatory activity ranging from 0.00 to 1.00 corresponding to the Metavir scoring system of grade A0 to A3. (A0=no activity, A1=minimal activity, A2=moderate activity, A3=severe activity).
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1954439
- UMLS CUI [1,2]
- C3642160
Beskrivning
Necroinflammatory Activity (METAVIR)
Datatyp
text
Alias
- UMLS CUI [1]
- C3897040
Beskrivning
Summary of Necroinflammatory Activity (METAVIR)
Datatyp
text
Alias
- UMLS CUI [1]
- C1954431
Beskrivning
The Hepatitis C Viral RNA quantitative transcription-mediated amplification (TMA) was used to quantitate the level of HCV RNA in serum or plasma.
Datatyp
float
Måttenheter
- [iU]/mL
Alias
- UMLS CUI [1,1]
- C0369335
- UMLS CUI [1,2]
- C1553166
Beskrivning
PK parameters for peginterferon alfa-2a
Datatyp
text
Alias
- UMLS CUI [1]
- C0391001
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
Beskrivning
HIV screening
Datatyp
text
Alias
- UMLS CUI [1]
- C0019682
Similar models
Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Lab Panels NCT00529568
C0022885 (UMLS CUI-2)
C0201480 (UMLS CUI [2])
C0022885 (UMLS CUI-2)
C0205288 (UMLS CUI [1,2])
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0202514 (UMLS CUI [2])
C3642160 (UMLS CUI [1,2])
C1553166 (UMLS CUI [1,2])