Information:
Fel:
ID
16752
Beskrivning
Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED); ODM derived from: https://clinicaltrials.gov/show/NCT00160251
Länk
https://clinicaltrials.gov/show/NCT00160251
Nyckelord
Versioner (1)
- 2016-08-03 2016-08-03 -
Uppladdad den
3 augusti 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00160251
Eligibility Chronic Hepatitis C NCT00160251
- StudyEvent: Eligibility
Similar models
Eligibility Chronic Hepatitis C NCT00160251
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
chronic hepatitis c (chc), genotype 1
Item
documented infection with chronic hepatitis c (chc), genotype 1.
boolean
C4049392 (UMLS CUI [1])
failure to respond to an adequate course of treatment with peginterferon-alfa plus ribavirin
Item
documented failure to respond to an adequate course of treatment (minimum 12 weeks) with peginterferon-alfa plus ribavirin (failure defined as <2 log drop in hcv-rna after 12 weeks of therapy or those who never become hepatitis c virus ribonucleic acid (hcv)-rna negative)
boolean
C0162643 (UMLS CUI [1,1])
C0919875 (UMLS CUI [1,2])
C1875630 (UMLS CUI [1,3])
C0919875 (UMLS CUI [1,2])
C1875630 (UMLS CUI [1,3])
no evidence of cirrhosis on liver biopsy.
Item
no evidence of cirrhosis on liver biopsy.
boolean
C0023890 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
results of physical examination and laboratory tests within specified ranges
Item
results of physical examination and laboratory tests within specified ranges.
boolean
C0031809 (UMLS CUI [1,1])
C0459422 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C0459422 (UMLS CUI [2,2])
C0459422 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C0459422 (UMLS CUI [2,2])
abstinence from use of abused substances
Item
abstinence from use of abused substances.
boolean
C3843422 (UMLS CUI [1,1])
C0687130 (UMLS CUI [1,2])
C0687130 (UMLS CUI [1,2])
exclusion criteria
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1])
pregnant or breastfeeding
Item
women who are pregnant or nursing a child.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
cirrhosis, co-infection with hepatitis b or human immunodeficiency virus (hiv), and african-american patients
Item
patients with cirrhosis, co-infection with hepatitis b or human immunodeficiency virus (hiv), and african-american patients (by protocol amendment 2, african-american patients can enroll).
boolean
C0023890 (UMLS CUI [1])
C0275524 (UMLS CUI [2,1])
C0019682 (UMLS CUI [2,2])
C0275524 (UMLS CUI [3,1])
C0019163 (UMLS CUI [3,2])
C0085756 (UMLS CUI [4])
C0275524 (UMLS CUI [2,1])
C0019682 (UMLS CUI [2,2])
C0275524 (UMLS CUI [3,1])
C0019163 (UMLS CUI [3,2])
C0085756 (UMLS CUI [4])
hepatitis c virus (hcv) polymerase or protease inhibitor
Item
previous treatment with any hepatitis c virus (hcv) polymerase or protease inhibitor.
boolean
C0019196 (UMLS CUI [1,1])
C2746051 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0033607 (UMLS CUI [2,2])
C2746051 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0033607 (UMLS CUI [2,2])
relapse
Item
patients who relapsed following response to previous treatment.
boolean
C0277556 (UMLS CUI [1])
advanced liver disease
Item
evidence of advanced liver disease, or liver disease from a cause other than chc.
boolean
C0860197 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
C0009488 (UMLS CUI [2])
psychiatric condition
Item
pre-existing psychiatric condition.
boolean
C0004936 (UMLS CUI [1])