ID
22363
Description
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
Keywords
Versions (2)
- 5/31/17 5/31/17 -
- 9/20/21 9/20/21 -
Uploaded on
May 31, 2017
DOI
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License
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
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
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
Liver Chemistry
Alias
- UMLS CUI-1
- C0232741
- UMLS CUI-2
- C0022885
Description
ALT
Data type
float
Measurement units
- [iU]/L
Alias
- UMLS CUI [1]
- C0201836
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 (excluded from this Protocol) Child-Pugh Class C=score >9 (excluded from this Protocol)
Data type
text
Alias
- UMLS CUI [1]
- C2347612
Description
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
Renal Assessments
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
determined by the Cockcroft- Gault formula
Data type
integer
Measurement units
- mL/min
Alias
- UMLS CUI [1]
- C2711451
Description
UP/CR
Data type
float
Measurement units
- mg/mg
Alias
- UMLS CUI [1]
- C1096054
Description
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.
Data type
float
Alias
- UMLS CUI [1]
- C0017654
Description
if required
Data type
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205288
Description
if required
Data type
text
Alias
- UMLS CUI [1]
- C0201721
Description
if required
Data type
text
Alias
- UMLS CUI [1]
- C0587362
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
in LOG IU/ML Summary of Log-Transformed HCV RNA (LOG IU/ML) at Baseline (Pre-antiviral Safety Population)
Data type
float
Measurement units
- [lg] [iU]/mL
Alias
- UMLS CUI [1]
- C0369335
Description
HCV genotype
Data type
text
Alias
- UMLS CUI [1]
- C1148363
Description
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.
Data type
text
Alias
- UMLS CUI [1]
- C0019682
Description
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.
Data type
text
Alias
- UMLS CUI [1]
- C1278302
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
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])