ID

29738

Description

A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00703118

Link

https://clinicaltrials.gov/show/NCT00703118

Keywords

Versions (1)
  1. 4/17/18 4/17/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 17, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00703118

English

Eligibility Hepatitis C, Chronic NCT00703118

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must have chronic hepatitis c infection (genotype 1) with hcv rna level >= 1000 iu/ml
Description

Chronic Hepatitis C HCV genotype determination | Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C1272251
patient must have failed at least 1 prior course of peg-ifn/rbv therapy (standard treatment)
Description

PEGINTERFERON/RIBAVIRIN Course Quantity failed

Data type

boolean

Alias
UMLS CUI [1,1]
C1875630
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0231175
patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Description

Contraceptive methods Quantity Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is a previous non-responder that is classified as a viral breakthrough case
Description

Patient Unresponsive to Treatment | Viral Breakthrough

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0205269
UMLS CUI [2]
C4053869
patient is infected with hepatitis c virus, genotype 1, exhibiting more than one subtype
Description

Hepatitis C HCV genotype determination | Subtype Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C0449560
UMLS CUI [2,2]
C1265611
patient has hepatitis c virus, genotype 1, and exhibits co-infection with any other genotype
Description

Hepatitis C virus genotype determination | Coinfection Hepatitis C virus genotype determination

Data type

boolean

Alias
UMLS CUI [1]
C1533728
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C1533728
evidence of decompensated liver disease
Description

Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C4075847
patient has condition that requires use of systemic corticosteroids
Description

Condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3653708
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Similar models

Eligibility Hepatitis C, Chronic NCT00703118

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C HCV genotype determination | Hepatitis C virus RNA assay
Item
patient must have chronic hepatitis c infection (genotype 1) with hcv rna level >= 1000 iu/ml
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1272251 (UMLS CUI [2])
PEGINTERFERON/RIBAVIRIN Course Quantity failed
Item
patient must have failed at least 1 prior course of peg-ifn/rbv therapy (standard treatment)
boolean
C1875630 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Contraceptive methods Quantity Willing
Item
patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
boolean
C0700589 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Patient Unresponsive to Treatment | Viral Breakthrough
Item
patient is a previous non-responder that is classified as a viral breakthrough case
boolean
C0030705 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C4053869 (UMLS CUI [2])
Hepatitis C HCV genotype determination | Subtype Quantity
Item
patient is infected with hepatitis c virus, genotype 1, exhibiting more than one subtype
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0449560 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Hepatitis C virus genotype determination | Coinfection Hepatitis C virus genotype determination
Item
patient has hepatitis c virus, genotype 1, and exhibits co-infection with any other genotype
boolean
C1533728 (UMLS CUI [1])
C0275524 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
Decompensated liver disease
Item
evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE
Item
patient has condition that requires use of systemic corticosteroids
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3653708 (UMLS CUI [1,3])
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