ID

40917

Beskrivning

Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755); ODM derived from: https://clinicaltrials.gov/show/NCT01544920

Länk

https://clinicaltrials.gov/show/NCT01544920

Nyckelord

Versioner (1)
  1. 2020-06-04 2020-06-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 juni 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01544920

Engelsk

Eligibility Hepatitis C, Chronic NCT01544920

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
is ≥ 40 kg and ≤ 125 kg.
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
documented chc genotype 1 with hcv rna ≥10,000 international units (iu)/ml
Beskrivning

Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C1272251
has il-28b cc allele gene
Beskrivning

IL-28B

Datatyp

boolean

Alias
UMLS CUI [1]
C3815173
has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma (non-invasive fibroscan and fibrotest can also be used for staging of liver disease).
Beskrivning

Liver Cirrhosis Absent Biopsy of liver | Liver carcinoma Absent Biopsy of liver | Liver disease Stage Fibroscan | Liver disease Stage FibroTest Score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0193388
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0193388
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C1306673
UMLS CUI [3,3]
C4522043
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C1306673
UMLS CUI [4,3]
C3642160
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection with the human immunodeficiency virus (hiv) or hepatitis b virus (hepatitis b surface antigen [hbsag] or hiv positive).
Beskrivning

HIV coinfection | HBV coinfection | Hepatitis B surface antigen positive | HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
UMLS CUI [3]
C0149709
UMLS CUI [4]
C0019699
previously treated with an interferon and ribavirin regimen or hcv direct acting antiviral regimen.
Beskrivning

Interferon | Ribavirin | HCV DIRECT ACTING ANTIVIRALS

Datatyp

boolean

Alias
UMLS CUI [1]
C3652465
UMLS CUI [2]
C0035525
UMLS CUI [3,1]
C0220847
UMLS CUI [3,2]
C3653501
treatment for hepatitis c with any investigational medication, or prior treatments with herbal remedies with known hepatotoxicity
Beskrivning

Investigational New Drugs Hepatitis C | Herbal medicine Associated with Hepatotoxicity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0019196
UMLS CUI [2,1]
C2240391
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0235378
receiving any medication(s) within 2 weeks prior to the day 1 visit that are highly dependent on cytochrome p450 3a4 (cyp3a4/5) for clearance, and for which elevated plasma concentrations could be associated with serious and/or life-threatening events
Beskrivning

Pharmaceutical Preparations Relationship Cytochrome P-450 CYP3A4 | Pharmaceutical Preparations Relationship Cytochrome P-450 CYP3A5 | Plasma concentration Associated with Life Threatening Adverse Event

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C3714798
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C3714750
UMLS CUI [3,1]
C0683150
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C1517874
participation in any other clinical trial within 30 days of the screening visit in this trial or intention to participate in another clinical trial during participation in this trial.
Beskrivning

Study Subject Participation Status | Clinical Trial

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
evidence of decompensated liver disease or hepatocellular carcinoma (hcc)
Beskrivning

Decompensated liver disease | Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C2239176
is diabetic and/or hypertensive with significant retinopathy
Beskrivning

Diabetic | Hypertensive | Retinal Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0241863
UMLS CUI [2]
C0857121
UMLS CUI [3]
C0035309
has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction.
Beskrivning

Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Completion of clinical trial | Immune System Disease | Chronic lung disease | Cardiac abnormalities | Cardiac dysfunction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
UMLS CUI [3]
C0021053
UMLS CUI [4]
C0746102
UMLS CUI [5]
C0018798
UMLS CUI [6]
C3277906
evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
Beskrivning

Malignant Neoplasm | Malignant Neoplasm Suspected | History of malignant neoplasm

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0455471
hemoglobin <12 g/dl for females and <13 g/dl for males
Beskrivning

Hemoglobin measurement | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
neutrophils <1,500/mm^3, or <1,200/mm^3 for participants of african descent
Beskrivning

Neutrophil count | African descent

Datatyp

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0027567
platelets <150,000/mm^3
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
direct bilirubin >1.5 x upper limit of normal (uln) of the laboratory reference range.
Beskrivning

Direct bilirubin increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0740434
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Similar models

Eligibility Hepatitis C, Chronic NCT01544920

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Body Weight
Item
is ≥ 40 kg and ≤ 125 kg.
boolean
C0005910 (UMLS CUI [1])
Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay
Item
documented chc genotype 1 with hcv rna ≥10,000 international units (iu)/ml
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1272251 (UMLS CUI [2])
IL-28B
Item
has il-28b cc allele gene
boolean
C3815173 (UMLS CUI [1])
Liver Cirrhosis Absent Biopsy of liver | Liver carcinoma Absent Biopsy of liver | Liver disease Stage Fibroscan | Liver disease Stage FibroTest Score
Item
has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma (non-invasive fibroscan and fibrotest can also be used for staging of liver disease).
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3,1])
C1306673 (UMLS CUI [3,2])
C4522043 (UMLS CUI [3,3])
C0023895 (UMLS CUI [4,1])
C1306673 (UMLS CUI [4,2])
C3642160 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
HIV coinfection | HBV coinfection | Hepatitis B surface antigen positive | HIV Seropositivity
Item
co-infection with the human immunodeficiency virus (hiv) or hepatitis b virus (hepatitis b surface antigen [hbsag] or hiv positive).
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
C0019699 (UMLS CUI [4])
Interferon | Ribavirin | HCV DIRECT ACTING ANTIVIRALS
Item
previously treated with an interferon and ribavirin regimen or hcv direct acting antiviral regimen.
boolean
C3652465 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
C0220847 (UMLS CUI [3,1])
C3653501 (UMLS CUI [3,2])
Investigational New Drugs Hepatitis C | Herbal medicine Associated with Hepatotoxicity
Item
treatment for hepatitis c with any investigational medication, or prior treatments with herbal remedies with known hepatotoxicity
boolean
C0013230 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C2240391 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0235378 (UMLS CUI [2,3])
Pharmaceutical Preparations Relationship Cytochrome P-450 CYP3A4 | Pharmaceutical Preparations Relationship Cytochrome P-450 CYP3A5 | Plasma concentration Associated with Life Threatening Adverse Event
Item
receiving any medication(s) within 2 weeks prior to the day 1 visit that are highly dependent on cytochrome p450 3a4 (cyp3a4/5) for clearance, and for which elevated plasma concentrations could be associated with serious and/or life-threatening events
boolean
C0013227 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C3714798 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C3714750 (UMLS CUI [2,3])
C0683150 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C1517874 (UMLS CUI [3,3])
Study Subject Participation Status | Clinical Trial
Item
participation in any other clinical trial within 30 days of the screening visit in this trial or intention to participate in another clinical trial during participation in this trial.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Decompensated liver disease | Liver carcinoma
Item
evidence of decompensated liver disease or hepatocellular carcinoma (hcc)
boolean
C4075847 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
Diabetic | Hypertensive | Retinal Disease
Item
is diabetic and/or hypertensive with significant retinopathy
boolean
C0241863 (UMLS CUI [1])
C0857121 (UMLS CUI [2])
C0035309 (UMLS CUI [3])
Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Completion of clinical trial | Immune System Disease | Chronic lung disease | Cardiac abnormalities | Cardiac dysfunction
Item
has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0021053 (UMLS CUI [3])
C0746102 (UMLS CUI [4])
C0018798 (UMLS CUI [5])
C3277906 (UMLS CUI [6])
Malignant Neoplasm | Malignant Neoplasm Suspected | History of malignant neoplasm
Item
evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0455471 (UMLS CUI [3])
Hemoglobin measurement | Gender
Item
hemoglobin <12 g/dl for females and <13 g/dl for males
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Neutrophil count | African descent
Item
neutrophils <1,500/mm^3, or <1,200/mm^3 for participants of african descent
boolean
C0200633 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
Platelet Count measurement
Item
platelets <150,000/mm^3
boolean
C0032181 (UMLS CUI [1])
Direct bilirubin increased
Item
direct bilirubin >1.5 x upper limit of normal (uln) of the laboratory reference range.
boolean
C0740434 (UMLS CUI [1])
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