ID

44585

Descrição

DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral); ODM derived from: https://clinicaltrials.gov/show/NCT02156570

Link

https://clinicaltrials.gov/show/NCT02156570

Palavras-chave

Versões (2)
  1. 01/06/2020 01/06/2020 -
  2. 27/09/2021 27/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT02156570

Inglês

Eligibility Hepatitis C NCT02156570

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
male and female patients aged 18 years and above
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
willing to use two effective methods of contraception during the treatment period and 24 weeks post.
Descrição

Contraceptive methods Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1265611
hbsag negative
Descrição

Hepatitis B surface antigen negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0919711
detectable hcv rna at screening (>10,000 iu/ml), and in the opinion of the investigator is unlikely to demonstrate spontaneous viral clearance
Descrição

Hepatitis C virus RNA assay

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1272251
compensated liver disease (child-pugh a)
Descrição

Compensated liver disease Child-Pugh Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C4050412
negative pregnancy test at screening and 24 hours prior to first dose of study drugs
Descrição

Pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0427780
medically stable on the basis of physical examination, medical history and vital signs
Descrição

Stable status Medical Physical Examination | Stable status Medical History | Stable status Medical Vital signs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C0031809
UMLS CUI [2,1]
C0205360
UMLS CUI [2,2]
C0205476
UMLS CUI [2,3]
C0262926
UMLS CUI [3,1]
C0205360
UMLS CUI [3,2]
C0205476
UMLS CUI [3,3]
C0518766
adequate english to provide reliable responses to the study questionnaires
Descrição

Language ability English | Questionnaires Completion

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1145677
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
recent hepatitis c infection, as defined by: a) i) first anti-hcv ab or hcv rna positive within the previous 6 months and ii) documented anti-hcv ab negative within the 24 months prior to anti-hcv antibody positive result, or b) i) first anti-hcv ab or hcv rna positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or alt> 10 x uln) within the previous 12 months prior to first positive hcv antibody or hcv rna, with no other cause of acute hepatitis identifiable
Descrição

Hepatitis C | Hepatitis C Antibody First | Hepatitis C RNA positive | Hepatitis C antibody negative | Status pre- Hepatitis C antibody positive | Hepatitis | Icterus | Alanine aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C0205435
UMLS CUI [3]
C0855842
UMLS CUI [4]
C0853904
UMLS CUI [5,1]
C0332152
UMLS CUI [5,2]
C0281863
UMLS CUI [6]
C0019158
UMLS CUI [7]
C0022346
UMLS CUI [8]
C0151905
if co-infection with hiv is documented, the subject must meet the following criteria:
Descrição

HIV coinfection | Criteria Fulfill

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
antiretroviral (arv) untreated for >8 weeks preceding screening visit with cd4 t cell count >500 cells/mm3 or
Descrição

Antiretroviral therapy Absent | Absolute CD4 T cell count

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1963724
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0519835
on a stable arv regimen for >8 weeks prior to screening visit, with cd4 t cell count >200 cells/mm3 and an undetectable plasma hiv rna level.
Descrição

Antiretroviral therapy Stable | Absolute CD4 T cell count | Plasma HIV RNA undetectable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1963724
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0519835
UMLS CUI [3,1]
C0032105
UMLS CUI [3,2]
C0877598
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
standard exclusions to rbv therapy
Descrição

Standard Exclusion Ribavirin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1442989
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C0035525
pregnancy/lactation or male subjects whose female partners are pregnant
Descrição

Pregnancy | Breast Feeding | Gender Partner Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C0032961
subject has a history of decompensated liver disease: history of ascites, hepatic encephalopathy, or bleeding oesophageal varices, and/or any of the following screening laboratory results: a.inr of ≥1.5; serum albumin <3.3 g/dl; serum total bilirubin >1.8 times upper limit of normal, unless isolated in subjects with gilbert's syndrome.
Descrição

Decompensated liver disease | Ascites | Hepatic Encephalopathy | Bleeding esophageal varices | INR | Serum albumin measurement | SERUM TOTAL BILIRUBIN ELEVATED | Exception Gilbert Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0019151
UMLS CUI [4]
C0155789
UMLS CUI [5]
C0525032
UMLS CUI [6]
C0523465
UMLS CUI [7]
C0595866
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0017551
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Similar models

Eligibility Hepatitis C NCT02156570

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
provision of written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
male and female patients aged 18 years and above
boolean
C0001779 (UMLS CUI [1])
Contraceptive methods Quantity
Item
willing to use two effective methods of contraception during the treatment period and 24 weeks post.
boolean
C0700589 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Hepatitis B surface antigen negative
Item
hbsag negative
boolean
C0919711 (UMLS CUI [1])
Hepatitis C virus RNA assay
Item
detectable hcv rna at screening (>10,000 iu/ml), and in the opinion of the investigator is unlikely to demonstrate spontaneous viral clearance
boolean
C1272251 (UMLS CUI [1])
Compensated liver disease Child-Pugh Classification
Item
compensated liver disease (child-pugh a)
boolean
C3839044 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Pregnancy test negative
Item
negative pregnancy test at screening and 24 hours prior to first dose of study drugs
boolean
C0427780 (UMLS CUI [1])
Stable status Medical Physical Examination | Stable status Medical History | Stable status Medical Vital signs
Item
medically stable on the basis of physical examination, medical history and vital signs
boolean
C0205360 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0205360 (UMLS CUI [2,1])
C0205476 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C0205360 (UMLS CUI [3,1])
C0205476 (UMLS CUI [3,2])
C0518766 (UMLS CUI [3,3])
Language ability English | Questionnaires Completion
Item
adequate english to provide reliable responses to the study questionnaires
boolean
C1145677 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Hepatitis C | Hepatitis C Antibody First | Hepatitis C RNA positive | Hepatitis C antibody negative | Status pre- Hepatitis C antibody positive | Hepatitis | Icterus | Alanine aminotransferase increased
Item
recent hepatitis c infection, as defined by: a) i) first anti-hcv ab or hcv rna positive within the previous 6 months and ii) documented anti-hcv ab negative within the 24 months prior to anti-hcv antibody positive result, or b) i) first anti-hcv ab or hcv rna positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or alt> 10 x uln) within the previous 12 months prior to first positive hcv antibody or hcv rna, with no other cause of acute hepatitis identifiable
boolean
C0019196 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
C0855842 (UMLS CUI [3])
C0853904 (UMLS CUI [4])
C0332152 (UMLS CUI [5,1])
C0281863 (UMLS CUI [5,2])
C0019158 (UMLS CUI [6])
C0022346 (UMLS CUI [7])
C0151905 (UMLS CUI [8])
HIV coinfection | Criteria Fulfill
Item
if co-infection with hiv is documented, the subject must meet the following criteria:
boolean
C4062778 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Antiretroviral therapy Absent | Absolute CD4 T cell count
Item
antiretroviral (arv) untreated for >8 weeks preceding screening visit with cd4 t cell count >500 cells/mm3 or
boolean
C1963724 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0519835 (UMLS CUI [2])
Antiretroviral therapy Stable | Absolute CD4 T cell count | Plasma HIV RNA undetectable
Item
on a stable arv regimen for >8 weeks prior to screening visit, with cd4 t cell count >200 cells/mm3 and an undetectable plasma hiv rna level.
boolean
C1963724 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0519835 (UMLS CUI [2])
C0032105 (UMLS CUI [3,1])
C0877598 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Standard Exclusion Ribavirin
Item
standard exclusions to rbv therapy
boolean
C1442989 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0035525 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Gender Partner Pregnancy
Item
pregnancy/lactation or male subjects whose female partners are pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
Decompensated liver disease | Ascites | Hepatic Encephalopathy | Bleeding esophageal varices | INR | Serum albumin measurement | SERUM TOTAL BILIRUBIN ELEVATED | Exception Gilbert Disease
Item
subject has a history of decompensated liver disease: history of ascites, hepatic encephalopathy, or bleeding oesophageal varices, and/or any of the following screening laboratory results: a.inr of ≥1.5; serum albumin <3.3 g/dl; serum total bilirubin >1.8 times upper limit of normal, unless isolated in subjects with gilbert's syndrome.
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C0155789 (UMLS CUI [4])
C0525032 (UMLS CUI [5])
C0523465 (UMLS CUI [6])
C0595866 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C0017551 (UMLS CUI [8,2])
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