ID

13712

Beschrijving

Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01467492

Link

https://clinicaltrials.gov/show/NCT01467492

Trefwoorden

  1. 29-02-16 29-02-16 -
Geüploaded op

29 februari 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Hepatitis C NCT01467492

Eligibility Hepatitis C NCT01467492

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants self-identify as black/african american (group a) or did not self-identify as black/african american (group b)
Beschrijving

ethnic group

Datatype

boolean

Alias
UMLS CUI [1]
C0015031
participants have genotype 1 chc and laboratory evidence of hepatitis c virus (hcv) infection for at least 6 months
Beschrijving

chronic hepatitis c; hepatitis c genotype

Datatype

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2]
C1148363
participants did not achieve sustained viral response 24 weeks after last dose of study drug (svr24), after at least 1 prior course of peg-ifn-alfa-2a/rbv therapy of standard duration
Beschrijving

dosage study drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0008972
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants have received previous treatment with telaprevir or any other protease inhibitor(s) for chc
Beschrijving

concomitant therapy telaprevir protease inhibitor

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C1876229
UMLS CUI [1,3]
C0033607
participants who have evidence of hepatic decompensation
Beschrijving

hepatic decompensation

Datatype

boolean

Alias
UMLS CUI [1]
C0085605
participants have diagnosed or suspected hepatocellular carcinoma
Beschrijving

hepatocellular carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C2239176
participants have any other cause of significant liver disease in addition to hcv
Beschrijving

liver disease

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
participants are currently abusing illicit drugs or alcohol, or have history of illicit substance or alcohol abuse within 2 years before the screening visit
Beschrijving

Substance Use Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
participants who participated in any investigational drug study within 90 days before dosing
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Hepatitis C NCT01467492

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ethnic group
Item
participants self-identify as black/african american (group a) or did not self-identify as black/african american (group b)
boolean
C0015031 (UMLS CUI [1])
chronic hepatitis c; hepatitis c genotype
Item
participants have genotype 1 chc and laboratory evidence of hepatitis c virus (hcv) infection for at least 6 months
boolean
C0524910 (UMLS CUI [1])
C1148363 (UMLS CUI [2])
dosage study drug
Item
participants did not achieve sustained viral response 24 weeks after last dose of study drug (svr24), after at least 1 prior course of peg-ifn-alfa-2a/rbv therapy of standard duration
boolean
C0178602 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
concomitant therapy telaprevir protease inhibitor
Item
participants have received previous treatment with telaprevir or any other protease inhibitor(s) for chc
boolean
C1707479 (UMLS CUI [1,1])
C1876229 (UMLS CUI [1,2])
C0033607 (UMLS CUI [1,3])
hepatic decompensation
Item
participants who have evidence of hepatic decompensation
boolean
C0085605 (UMLS CUI [1])
hepatocellular carcinoma
Item
participants have diagnosed or suspected hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
liver disease
Item
participants have any other cause of significant liver disease in addition to hcv
boolean
C0023895 (UMLS CUI [1])
Substance Use Disorder
Item
participants are currently abusing illicit drugs or alcohol, or have history of illicit substance or alcohol abuse within 2 years before the screening visit
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status
Item
participants who participated in any investigational drug study within 90 days before dosing
boolean
C2348568 (UMLS CUI [1])

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