ID
22362
Beschrijving
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). NCT00516321 https://clinicaltrials.gov/ct2/show/NCT00516321 Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) 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-2a Plus Ribavirin
Link
https://clinicaltrials.gov/ct2/show/NCT00516321
Trefwoorden
Versies (2)
- 31-05-17 31-05-17 -
- 20-09-21 20-09-21 -
Geüploaded op
31 mei 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
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Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Lab panels NCT00516321
Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Lab panels NCT00516321
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
Maateenheden
- 10*3/uL
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
PT
Datatype
integer
Alias
- UMLS CUI [1]
- C0033707
Beschrijving
aPTT
Datatype
integer
Alias
- UMLS CUI [1]
- C0030605
Beschrijving
Thrombopoietin
Datatype
float
Maateenheden
- ng/L
Alias
- UMLS CUI [1]
- C2699935
Beschrijving
Liver Chemistry Assessments
Alias
- UMLS CUI-1
- C0232741
- UMLS CUI-2
- C0022885
Beschrijving
Albumin
Datatype
float
Maateenheden
- g/L
Alias
- UMLS CUI [1]
- C0201838
Beschrijving
CPK
Datatype
float
Alias
- UMLS CUI [1]
- C0201973
Beschrijving
LDH
Datatype
float
Alias
- UMLS CUI [1]
- C0202113
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
Datatype
text
Alias
- UMLS CUI [1]
- C2347612
Beschrijving
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.
Datatype
float
Alias
- UMLS CUI [1]
- C1718072
Beschrijving
The following are required for subjects who meet the ALT and bilirubin threshold stopping criteria but are optional for other abnormal liver chemistries
Datatype
float
Alias
- UMLS CUI [1]
- C0587178
Beschrijving
anti-smooth muscle antibody
Datatype
float
Alias
- UMLS CUI [1]
- C0201511
Beschrijving
Type 1 anti-liver kidney microsomal antibodies
Datatype
float
Alias
- UMLS CUI [1]
- C0373868
Beschrijving
Hepatitis A IgM antibody
Datatype
float
Alias
- UMLS CUI [1]
- C0373852
Beschrijving
Hepatitis B surface antigen and Hepatitis B Core Antibody (IgM)
Datatype
float
Alias
- UMLS CUI [1]
- C0201477
- UMLS CUI [2]
- C0201480
Beschrijving
Cytomegalovirus IgM antibody
Datatype
float
Alias
- UMLS CUI [1]
- C3272889
Beschrijving
(or if unavailable, obtain heterophile antibody or monospot testing)
Datatype
float
Alias
- UMLS CUI [1]
- C2732963
Beschrijving
(if subject resides outside the USA or Canada, or has travelled outside USA or Canada in past 3 months)
Datatype
float
Alias
- UMLS CUI [1]
- C3272944
Beschrijving
Renal Laboratory Parameters
Alias
- UMLS CUI-1
- C0232804
- UMLS CUI-2
- C0022885
Beschrijving
Serum creatinine
Datatype
float
Maateenheden
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
Creatinine clearance
Datatype
integer
Maateenheden
- mL/min
Alias
- UMLS CUI [1]
- C2711451
Beschrijving
UP/CR
Datatype
float
Alias
- UMLS CUI [1]
- C1096054
Beschrijving
GFR was calculated by the Cockcroft-Gault formula.
Datatype
float
Alias
- UMLS CUI [1]
- C0017654
Beschrijving
Microscopic Urine Analysis
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205288
Beschrijving
If the UP/CR is above the ULN, then a urine protein electrophoresis will also be performed
Datatype
text
Alias
- UMLS CUI [1]
- C0201721
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
HCV RNA
Datatype
float
Maateenheden
- [iU]/L
Alias
- UMLS CUI [1]
- C0369335
Beschrijving
HVR RNA
Datatype
float
Maateenheden
- [iU]/L
Beschrijving
HCV genotype 2/3 HCV genotype non 2/3
Datatype
integer
Alias
- UMLS CUI [1]
- C1148363
Beschrijving
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).
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1954439
- UMLS CUI [1,2]
- C3642160
Beschrijving
Necroinflammatory Activity (METAVIR)
Datatype
text
Alias
- UMLS CUI [1]
- C1954431
Beschrijving
The Hepatitis C Viral RNA quantitative transcription-mediated amplification (TMA) was used to quantitate the level of HCV RNA in serum or plasma.
Datatype
float
Maateenheden
- [iU]/L
Alias
- UMLS CUI [1,1]
- C0369335
- UMLS CUI [1,2]
- C1553166
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
Beschrijving
HIV screening
Datatype
text
Alias
- UMLS CUI [1]
- C0019682
Similar models
Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Lab panels NCT00516321
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])