ID

40917

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01544920

Keywords

versioni (1)
  1. 04/06/20 04/06/20 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

4 giugno 2020

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Hepatitis C, Chronic NCT01544920

Inglese

Eligibility Hepatitis C, Chronic NCT01544920

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

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

Body Weight

Tipo di dati

boolean

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

Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay

Tipo di dati

boolean

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

IL-28B

Tipo di dati

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).
Descrizione

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

Tipo di dati

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
Descrizione

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).
Descrizione

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

Tipo di dati

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.
Descrizione

Interferon | Ribavirin | HCV DIRECT ACTING ANTIVIRALS

Tipo di dati

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
Descrizione

Investigational New Drugs Hepatitis C | Herbal medicine Associated with Hepatotoxicity

Tipo di dati

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
Descrizione

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

Tipo di dati

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.
Descrizione

Study Subject Participation Status | Clinical Trial

Tipo di dati

boolean

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

Decompensated liver disease | Liver carcinoma

Tipo di dati

boolean

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

Diabetic | Hypertensive | Retinal Disease

Tipo di dati

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.
Descrizione

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

Tipo di dati

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
Descrizione

Malignant Neoplasm | Malignant Neoplasm Suspected | History of malignant neoplasm

Tipo di dati

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
Descrizione

Hemoglobin measurement | Gender

Tipo di dati

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
Descrizione

Neutrophil count | African descent

Tipo di dati

boolean

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

Platelet Count measurement

Tipo di dati

boolean

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

Direct bilirubin increased

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0740434
Ritorna all'inizio della pagina

Similar models

Eligibility Hepatitis C, Chronic NCT01544920

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial