ID
22362
Beschreibung
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
Stichworte
Versionen (2)
- 31.05.17 31.05.17 -
- 20.09.21 20.09.21 -
Hochgeladen am
31. Mai 2017
DOI
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Lizenz
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
Beschreibung
Haematology
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C0022885
Beschreibung
Complete Blood Count
Datentyp
text
Alias
- UMLS CUI [1]
- C0009555
Beschreibung
red blood cell
Datentyp
float
Maßeinheiten
- 10*6/uL
Alias
- UMLS CUI [1]
- C0014772
Beschreibung
haemoglobin
Datentyp
float
Maßeinheiten
- g/L
Alias
- UMLS CUI [1]
- C0518015
Beschreibung
haematocrit
Datentyp
float
Alias
- UMLS CUI [1]
- C0018935
Beschreibung
platelet count
Datentyp
float
Maßeinheiten
- 10*3/uL
Alias
- UMLS CUI [1]
- C0005821
Beschreibung
WBC
Datentyp
text
Maßeinheiten
- 10*3/uL
Alias
- UMLS CUI [1]
- C0023508
Beschreibung
neutrophils
Datentyp
float
Maßeinheiten
- 10*3/uL
Alias
- UMLS CUI [1]
- C0948762
Beschreibung
lymphocytes
Datentyp
float
Maßeinheiten
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200635
Beschreibung
monocytes
Datentyp
float
Maßeinheiten
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200637
Beschreibung
eosinophils
Datentyp
float
Maßeinheiten
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200638
Beschreibung
basophils
Datentyp
float
Maßeinheiten
- 10*3/uL
Alias
- UMLS CUI [1]
- C0200641
Beschreibung
MCV
Datentyp
float
Maßeinheiten
- fL
Alias
- UMLS CUI [1]
- C1948043
Beschreibung
INR
Datentyp
float
Alias
- UMLS CUI [1]
- C0525032
Beschreibung
PT
Datentyp
integer
Alias
- UMLS CUI [1]
- C0033707
Beschreibung
aPTT
Datentyp
integer
Alias
- UMLS CUI [1]
- C0030605
Beschreibung
Thrombopoietin
Datentyp
float
Maßeinheiten
- ng/L
Alias
- UMLS CUI [1]
- C2699935
Beschreibung
Liver Chemistry Assessments
Alias
- UMLS CUI-1
- C0232741
- UMLS CUI-2
- C0022885
Beschreibung
Albumin
Datentyp
float
Maßeinheiten
- g/L
Alias
- UMLS CUI [1]
- C0201838
Beschreibung
CPK
Datentyp
float
Alias
- UMLS CUI [1]
- C0201973
Beschreibung
LDH
Datentyp
float
Alias
- UMLS CUI [1]
- C0202113
Beschreibung
Measure: Total bilirubin, Serum albumin, INR, Ascites, Hepatic encephalopathy
Datentyp
integer
Alias
- UMLS CUI [1]
- C4055253
Beschreibung
Child-Pugh Class A=score 5-6 Child-Pugh Class B=score 7-9
Datentyp
text
Alias
- UMLS CUI [1]
- C2347612
Beschreibung
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.
Datentyp
float
Alias
- UMLS CUI [1]
- C1718072
Beschreibung
The following are required for subjects who meet the ALT and bilirubin threshold stopping criteria but are optional for other abnormal liver chemistries
Datentyp
float
Alias
- UMLS CUI [1]
- C0587178
Beschreibung
anti-smooth muscle antibody
Datentyp
float
Alias
- UMLS CUI [1]
- C0201511
Beschreibung
Type 1 anti-liver kidney microsomal antibodies
Datentyp
float
Alias
- UMLS CUI [1]
- C0373868
Beschreibung
Hepatitis A IgM antibody
Datentyp
float
Alias
- UMLS CUI [1]
- C0373852
Beschreibung
Hepatitis B surface antigen and Hepatitis B Core Antibody (IgM)
Datentyp
float
Alias
- UMLS CUI [1]
- C0201477
- UMLS CUI [2]
- C0201480
Beschreibung
Cytomegalovirus IgM antibody
Datentyp
float
Alias
- UMLS CUI [1]
- C3272889
Beschreibung
(or if unavailable, obtain heterophile antibody or monospot testing)
Datentyp
float
Alias
- UMLS CUI [1]
- C2732963
Beschreibung
(if subject resides outside the USA or Canada, or has travelled outside USA or Canada in past 3 months)
Datentyp
float
Alias
- UMLS CUI [1]
- C3272944
Beschreibung
Renal Laboratory Parameters
Alias
- UMLS CUI-1
- C0232804
- UMLS CUI-2
- C0022885
Beschreibung
Serum creatinine
Datentyp
float
Maßeinheiten
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
Creatinine clearance
Datentyp
integer
Maßeinheiten
- mL/min
Alias
- UMLS CUI [1]
- C2711451
Beschreibung
UP/CR
Datentyp
float
Alias
- UMLS CUI [1]
- C1096054
Beschreibung
GFR was calculated by the Cockcroft-Gault formula.
Datentyp
float
Alias
- UMLS CUI [1]
- C0017654
Beschreibung
Microscopic Urine Analysis
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205288
Beschreibung
If the UP/CR is above the ULN, then a urine protein electrophoresis will also be performed
Datentyp
text
Alias
- UMLS CUI [1]
- C0201721
Beschreibung
Urinalysis Dipstick
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C0022885
Beschreibung
Urine Urobilinogen
Datentyp
float
Maßeinheiten
- umol/L
Alias
- UMLS CUI [1]
- C0427736
Beschreibung
Urine Protein
Datentyp
float
Maßeinheiten
- g/L
Alias
- UMLS CUI [1]
- C0262923
Beschreibung
Urine Occult Blood
Datentyp
integer
Maßeinheiten
- Ery/uL
Alias
- UMLS CUI [1]
- C2188744
- UMLS CUI [2]
- C0202514
Beschreibung
Urine Ketones
Datentyp
float
Maßeinheiten
- mmol/L
Alias
- UMLS CUI [1]
- C1991100
Beschreibung
Urine Bilirubin
Datentyp
integer
Alias
- UMLS CUI [1]
- C0042040
Beschreibung
Urine Glucose
Datentyp
float
Maßeinheiten
- mmol/L
Alias
- UMLS CUI [1]
- C0004076
Beschreibung
Urine pH
Datentyp
float
Alias
- UMLS CUI [1]
- C0042044
Beschreibung
Urine Specific Gravity
Datentyp
float
Alias
- UMLS CUI [1]
- C0202517
Beschreibung
Other Laboratory Screenings
Alias
- UMLS CUI-1
- C0022885
Beschreibung
HCV RNA
Datentyp
float
Maßeinheiten
- [iU]/L
Alias
- UMLS CUI [1]
- C0369335
Beschreibung
HVR RNA
Datentyp
float
Maßeinheiten
- [iU]/L
Beschreibung
HCV genotype 2/3 HCV genotype non 2/3
Datentyp
integer
Alias
- UMLS CUI [1]
- C1148363
Beschreibung
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).
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1954439
- UMLS CUI [1,2]
- C3642160
Beschreibung
Necroinflammatory Activity (METAVIR)
Datentyp
text
Alias
- UMLS CUI [1]
- C1954431
Beschreibung
The Hepatitis C Viral RNA quantitative transcription-mediated amplification (TMA) was used to quantitate the level of HCV RNA in serum or plasma.
Datentyp
float
Maßeinheiten
- [iU]/L
Alias
- UMLS CUI [1,1]
- C0369335
- UMLS CUI [1,2]
- C1553166
Beschreibung
A screening beta-human chorionic gonadotrophin (beta-hCG) pregnancy test was mandatory for all female subjects of childbearing potential per local standards
Datentyp
text
Alias
- UMLS CUI [1]
- C0430056
Beschreibung
HIV screening
Datentyp
text
Alias
- UMLS CUI [1]
- C0019682
Ähnliche Modelle
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])