Informações:
Falhas:
ID
39686
Descrição
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
Palavras-chave
Versões (1)
- 10/02/2020 10/02/2020 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
10 de fevereiro de 2020
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatitis C Virus NCT02103699
Eligibility Hepatitis C Virus NCT02103699
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C Virus NCT02103699
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
C0008952 (UMLS CUI [1,2])
C0162648 (UMLS CUI [2])
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])
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])
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])
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])
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])