ID

39732

Descrição

An Observational Study of Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) on Predictive Values of RVR on Sustained Virological Response in Different Stages of Liver Fibrosis in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1; ODM derived from: https://clinicaltrials.gov/show/NCT01750216

Link

https://clinicaltrials.gov/show/NCT01750216

Palavras-chave

Versões (1)
  1. 14/02/2020 14/02/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

14 de fevereiro de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01750216

Inglês

Eligibility Hepatitis C, Chronic NCT01750216

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Descrição

Adult | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
chronic hepatitis c genotype 1
Descrição

Chronic Hepatitis C Genotype

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
treatment-naïve, i.e. have not been previously treated with pegylated interferon, standard interferon and ribavirin
Descrição

Therapy naive | PEGINTERFERON Absent | Interferon Absent | Ribavirin Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0982327
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3652465
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0035525
UMLS CUI [4,2]
C0332197
confirmed serum positive hcv rna
Descrição

Serum Hepatitis C RNA positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C0855842
liver fibrosis confirmed histologically or by fibroscan up to 24 months before treatment
Descrição

Liver Fibrosis Histology | Liver Fibrosis Fibroscan

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0239946
UMLS CUI [1,2]
C0344441
UMLS CUI [2,1]
C0239946
UMLS CUI [2,2]
C4522043
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
any contraindications according to the summary of product characteristics for pegasys or copegus
Descrição

Medical contraindication Pegasys | Medical contraindication Copegus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1176430
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1170183
co-infection with hepatitis b or hiv
Descrição

HBV coinfection | Human immunodeficiency virus (HIV) coinfection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
post-transplant patients
Descrição

Patients Post Transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0040732
end stage renal disease (creatinine clearance < 15 ml/min)
Descrição

Kidney Failure, Chronic | Creatinine clearance measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0373595
patients treated with immunotherapy
Descrição

Immunotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021083
pregnant women and male partners of women who are pregnant
Descrição

Pregnancy | Gender Partner Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C0032961
female patients of childbearing potential and male patients with female partners of childbearing potential who are unable or unwilling to use effective and continuous contraception during the treatment and for 4 months (females) and 7 months (males) thereafter
Descrição

Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling | Gender Partner Childbearing Potential | Gender Contraceptive methods Unable | Gender Contraceptive methods Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C3831118
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C1299582
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0700589
UMLS CUI [5,3]
C0558080
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Similar models

Eligibility Hepatitis C, Chronic NCT01750216

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic Hepatitis C Genotype
Item
chronic hepatitis c genotype 1
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy naive | PEGINTERFERON Absent | Interferon Absent | Ribavirin Absent
Item
treatment-naïve, i.e. have not been previously treated with pegylated interferon, standard interferon and ribavirin
boolean
C0919936 (UMLS CUI [1])
C0982327 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3652465 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0035525 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Serum Hepatitis C RNA positive
Item
confirmed serum positive hcv rna
boolean
C0229671 (UMLS CUI [1,1])
C0855842 (UMLS CUI [1,2])
Liver Fibrosis Histology | Liver Fibrosis Fibroscan
Item
liver fibrosis confirmed histologically or by fibroscan up to 24 months before treatment
boolean
C0239946 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
C0239946 (UMLS CUI [2,1])
C4522043 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Pegasys | Medical contraindication Copegus
Item
any contraindications according to the summary of product characteristics for pegasys or copegus
boolean
C1301624 (UMLS CUI [1,1])
C1176430 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1170183 (UMLS CUI [2,2])
HBV coinfection | Human immunodeficiency virus (HIV) coinfection
Item
co-infection with hepatitis b or hiv
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Patients Post Transplantation
Item
post-transplant patients
boolean
C0030705 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
Kidney Failure, Chronic | Creatinine clearance measurement
Item
end stage renal disease (creatinine clearance < 15 ml/min)
boolean
C0022661 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Immunotherapy
Item
patients treated with immunotherapy
boolean
C0021083 (UMLS CUI [1])
Pregnancy | Gender Partner Pregnancy
Item
pregnant women and male partners of women who are pregnant
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0032961 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling | Gender Partner Childbearing Potential | Gender Contraceptive methods Unable | Gender Contraceptive methods Unwilling
Item
female patients of childbearing potential and male patients with female partners of childbearing potential who are unable or unwilling to use effective and continuous contraception during the treatment and for 4 months (females) and 7 months (males) thereafter
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C3831118 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0558080 (UMLS CUI [5,3])
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