ID

16752

Description

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

Link

https://clinicaltrials.gov/show/NCT00160251

Keywords

Versions (1)
  1. 8/3/16 8/3/16 -
Uploaded on

August 3, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00160251

English

Eligibility Chronic Hepatitis C NCT00160251

1 forms  
Criteria
Description

Criteria

documented infection with chronic hepatitis c (chc), genotype 1.
Description

chronic hepatitis c (chc), genotype 1

Data type

boolean

Alias
UMLS CUI [1]
C4049392
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)
Description

failure to respond to an adequate course of treatment with peginterferon-alfa plus ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0162643
UMLS CUI [1,2]
C0919875
UMLS CUI [1,3]
C1875630
no evidence of cirrhosis on liver biopsy.
Description

no evidence of cirrhosis on liver biopsy.

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0193388
results of physical examination and laboratory tests within specified ranges.
Description

results of physical examination and laboratory tests within specified ranges

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0459422
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C0459422
abstinence from use of abused substances.
Description

abstinence from use of abused substances

Data type

boolean

Alias
UMLS CUI [1,1]
C3843422
UMLS CUI [1,2]
C0687130
key exclusion criteria:
Description

exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
women who are pregnant or nursing a child.
Description

pregnant or breastfeeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
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).
Description

cirrhosis, co-infection with hepatitis b or human immunodeficiency virus (hiv), and african-american patients

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0019682
UMLS CUI [3,1]
C0275524
UMLS CUI [3,2]
C0019163
UMLS CUI [4]
C0085756
previous treatment with any hepatitis c virus (hcv) polymerase or protease inhibitor.
Description

hepatitis c virus (hcv) polymerase or protease inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C2746051
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0033607
patients who relapsed following response to previous treatment.
Description

relapse

Data type

boolean

Alias
UMLS CUI [1]
C0277556
evidence of advanced liver disease, or liver disease from a cause other than chc.
Description

advanced liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0860197
UMLS CUI [2]
C0009488
pre-existing psychiatric condition.
Description

psychiatric condition

Data type

boolean

Alias
UMLS CUI [1]
C0004936
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Similar models

Eligibility Chronic Hepatitis C NCT00160251

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
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])
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])
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])
abstinence from use of abused substances
Item
abstinence from use of abused substances.
boolean
C3843422 (UMLS CUI [1,1])
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])
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])
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])
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])
psychiatric condition
Item
pre-existing psychiatric condition.
boolean
C0004936 (UMLS CUI [1])
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