ID

39686

Description

A Study to Examine Patient Characteristics, Health Care Management and Health Outcomes of Hepatitis C Virus (HCV) Patients Treated With Simeprevir; ODM derived from: https://clinicaltrials.gov/show/NCT02103699

Link

https://clinicaltrials.gov/show/NCT02103699

Keywords

Versions (1)
  1. 2/10/20 2/10/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 10, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C Virus NCT02103699

English

Eligibility Hepatitis C Virus NCT02103699

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who have genotype 1 chronic hepatitis c infection
Description

Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
hepatitis c virus (hcv) ribonucleic acid (rna) test result above the limit of quantification before initiation of simeprevir-based therapy
Description

Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1]
C1272251
health care provider decision to treat patient with a simeprevir-based therapy, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (<=) 28 days will be enrolled into the study
Description

simeprevir

Data type

boolean

Alias
UMLS CUI [1]
C2605855
prior hcv treatment must be completed more than 3 months before initiation of simeprevir-based therapy
Description

Prior Therapy Completed Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0019196
in the opinion of the health care provider, the patient will attend routine standard of care visits, either at enrolled site or by virtual/telemedicine
Description

Standard of Care Clinic Visits | Telemedicine

Data type

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0008952
UMLS CUI [2]
C0162648
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
non-genotype 1 hcv infected patients
Description

Absence Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0524910
UMLS CUI [1,3]
C1533728
absolute contraindication to any component of prescribed hcv treatment per prescribing information
Description

Medical contraindication Component Hepatitis C treatment prescribed

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C2367818
patient is currently enrolled in an interventional study
Description

Study Subject Participation Status | Interventional Study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
past use of an hcv direct-acting antiviral therapy
Description

HCV DIRECT ACTING ANTIVIRALS

Data type

boolean

Alias
UMLS CUI [1,1]
C0220847
UMLS CUI [1,2]
C3653501
any investigational drug use within 30 days before initiation of simeprevir-based therapy
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Hepatitis C Virus NCT02103699

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
patients who have genotype 1 chronic hepatitis c infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
hepatitis c virus (hcv) ribonucleic acid (rna) test result above the limit of quantification before initiation of simeprevir-based therapy
boolean
C1272251 (UMLS CUI [1])
simeprevir
Item
health care provider decision to treat patient with a simeprevir-based therapy, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (<=) 28 days will be enrolled into the study
boolean
C2605855 (UMLS CUI [1])
Prior Therapy Completed Hepatitis C
Item
prior hcv treatment must be completed more than 3 months before initiation of simeprevir-based therapy
boolean
C1514463 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Standard of Care Clinic Visits | Telemedicine
Item
in the opinion of the health care provider, the patient will attend routine standard of care visits, either at enrolled site or by virtual/telemedicine
boolean
C2936643 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
C0162648 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Absence Chronic Hepatitis C Genotype
Item
non-genotype 1 hcv infected patients
boolean
C0332197 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
C1533728 (UMLS CUI [1,3])
Medical contraindication Component Hepatitis C treatment prescribed
Item
absolute contraindication to any component of prescribed hcv treatment per prescribing information
boolean
C1301624 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C2367818 (UMLS CUI [1,3])
Study Subject Participation Status | Interventional Study
Item
patient is currently enrolled in an interventional study
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
HCV DIRECT ACTING ANTIVIRALS
Item
past use of an hcv direct-acting antiviral therapy
boolean
C0220847 (UMLS CUI [1,1])
C3653501 (UMLS CUI [1,2])
Investigational New Drugs
Item
any investigational drug use within 30 days before initiation of simeprevir-based therapy
boolean
C0013230 (UMLS CUI [1])
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