ID
43968
Description
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
Keywords
Versions (2)
- 5/31/17 5/31/17 -
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
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
Description
Haematology
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C0022885
Description
Complete Blood Count
Data type
text
Alias
- UMLS CUI [1]
- C0009555
Description
red blood cell
Data type
float
Measurement units
- 10*6/uL
Alias
- UMLS CUI [1]
- C0014772
Description
haemoglobin
Data type
float
Measurement units
- g/L
Alias
- UMLS CUI [1]
- C0518015
Description
haematocrit
Data type
float
Alias
- UMLS CUI [1]
- C0018935
Description
platelet count
Data type
float
Measurement units
- 10*3/uL
Alias
- UMLS CUI [1]
- C0005821
Description
WBC
Data type
text
Measurement units
- 10*3/uL
Alias
- UMLS CUI [1]
- C0023508
Description
neutrophils
Data type
float
Measurement units
- 10*3/uL
Alias
- UMLS CUI [1]
- C0948762
Description
lymphocytes
Data type
float
Measurement units
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200635
Description
monocytes
Data type
float
Measurement units
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200637
Description
eosinophils
Data type
float
Measurement units
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200638
Description
basophils
Data type
float
Measurement units
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200641
Description
MCV
Data type
float
Measurement units
- fL
Alias
- UMLS CUI [1]
- C1948043
Description
INR
Data type
float
Alias
- UMLS CUI [1]
- C0525032
Description
PT
Data type
integer
Alias
- UMLS CUI [1]
- C0033707
Description
aPTT
Data type
integer
Alias
- UMLS CUI [1]
- C0030605
Description
Thrombopoietin
Data type
float
Measurement units
- ng/L
Alias
- UMLS CUI [1]
- C2699935
Description
Liver Chemistry Assessments
Alias
- UMLS CUI-1
- C0232741
- UMLS CUI-2
- C0022885
Description
Albumin
Data type
float
Measurement units
- g/L
Alias
- UMLS CUI [1]
- C0201838
Description
CPK
Data type
float
Alias
- UMLS CUI [1]
- C0201973
Description
LDH
Data type
float
Alias
- UMLS CUI [1]
- C0202113
Description
Measure: Total bilirubin, Serum albumin, INR, Ascites, Hepatic encephalopathy
Data type
integer
Alias
- UMLS CUI [1]
- C4055253
Description
Child-Pugh Class A=score 5-6 Child-Pugh Class B=score 7-9
Data type
text
Alias
- UMLS CUI [1]
- C4050412
Description
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.
Data type
float
Alias
- UMLS CUI [1]
- C1718072
Description
The following are required for subjects who meet the ALT and bilirubin threshold stopping criteria but are optional for other abnormal liver chemistries
Data type
float
Alias
- UMLS CUI [1]
- C0587178
Description
anti-smooth muscle antibody
Data type
float
Alias
- UMLS CUI [1]
- C0201511
Description
Type 1 anti-liver kidney microsomal antibodies
Data type
float
Alias
- UMLS CUI [1]
- C0373868
Description
Hepatitis A IgM antibody
Data type
float
Alias
- UMLS CUI [1]
- C0373852
Description
Hepatitis B surface antigen and Hepatitis B Core Antibody (IgM)
Data type
float
Alias
- UMLS CUI [1]
- C0201477
- UMLS CUI [2]
- C0201480
Description
Cytomegalovirus IgM antibody
Data type
float
Alias
- UMLS CUI [1]
- C3272889
Description
(or if unavailable, obtain heterophile antibody or monospot testing)
Data type
float
Alias
- UMLS CUI [1]
- C2732963
Description
(if subject resides outside the USA or Canada, or has travelled outside USA or Canada in past 3 months)
Data type
float
Alias
- UMLS CUI [1]
- C3272944
Description
Renal Laboratory Parameters
Alias
- UMLS CUI-1
- C0232804
- UMLS CUI-2
- C0022885
Description
Serum creatinine
Data type
float
Measurement units
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Description
Creatinine clearance
Data type
integer
Measurement units
- mL/min
Alias
- UMLS CUI [1]
- C2711451
Description
UP/CR
Data type
float
Alias
- UMLS CUI [1]
- C1096054
Description
GFR was calculated by the Cockcroft-Gault formula.
Data type
float
Alias
- UMLS CUI [1]
- C0017654
Description
Microscopic Urine Analysis
Data type
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205288
Description
If the UP/CR is above the ULN, then a urine protein electrophoresis will also be performed
Data type
text
Alias
- UMLS CUI [1]
- C0201721
Description
Urinalysis Dipstick
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C0022885
Description
Urine Urobilinogen
Data type
float
Measurement units
- umol/L
Alias
- UMLS CUI [1]
- C0427736
Description
Urine Protein
Data type
float
Measurement units
- g/L
Alias
- UMLS CUI [1]
- C0262923
Description
Urine Occult Blood
Data type
integer
Measurement units
- Ery/uL
Alias
- UMLS CUI [1]
- C2188744
- UMLS CUI [2]
- C0202514
Description
Urine Ketones
Data type
float
Measurement units
- mmol/L
Alias
- UMLS CUI [1]
- C1991100
Description
Urine Bilirubin
Data type
integer
Alias
- UMLS CUI [1]
- C0042040
Description
Urine Glucose
Data type
float
Measurement units
- mmol/L
Alias
- UMLS CUI [1]
- C0004076
Description
Urine pH
Data type
float
Alias
- UMLS CUI [1]
- C0042044
Description
Urine Specific Gravity
Data type
float
Alias
- UMLS CUI [1]
- C0202517
Description
Other Laboratory Screenings
Alias
- UMLS CUI-1
- C0022885
Description
HCV RNA
Data type
float
Measurement units
- [iU]/L
Alias
- UMLS CUI [1]
- C0369335
Description
HVR RNA
Data type
float
Measurement units
- [iU]/L
Description
HCV genotype 2/3 HCV genotype non 2/3
Data type
integer
Alias
- UMLS CUI [1]
- C1148363
Description
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).
Data type
integer
Alias
- UMLS CUI [1,1]
- C1954439
- UMLS CUI [1,2]
- C3642160
Description
Necroinflammatory Activity (METAVIR)
Data type
text
Alias
- UMLS CUI [1]
- C1954431
Description
The Hepatitis C Viral RNA quantitative transcription-mediated amplification (TMA) was used to quantitate the level of HCV RNA in serum or plasma.
Data type
float
Measurement units
- [iU]/L
Alias
- UMLS CUI [1,1]
- C0369335
- UMLS CUI [1,2]
- C1553166
Description
A screening beta-human chorionic gonadotrophin (beta-hCG) pregnancy test was mandatory for all female subjects of childbearing potential per local standards
Data type
text
Alias
- UMLS CUI [1]
- C0430056
Description
HIV screening
Data type
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])