ID

17546

Descripción

Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.; ODM derived from: https://clinicaltrials.gov/show/NCT00107653

Link

https://clinicaltrials.gov/show/NCT00107653

Palabras clave

Versiones (1)
  1. 22/9/16 22/9/16 -
Subido en

22 de septiembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00107653

Inglés

Eligibility Hepatitis C, Chronic NCT00107653

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients 18-65 years of age
Descripción

Adult | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
chc, genotype 1
Descripción

Chronic hepatitis C genotype 1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4049392
serologic evidence of chc infection by an antibody test
Descripción

Chronic Hepatitis C Evidence Serologic | Antibody test

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205473
UMLS CUI [2]
C0580327
chronic liver disease, consistent with chc infection on a liver biopsy obtained within the past 18 months
Descripción

Chronic liver disease Consistent with Hepatitis C, Chronic | Biopsy of liver

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0341439
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524910
UMLS CUI [2]
C0193388
compensated liver disease
Descripción

Compensated liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3839044
use of 2 forms of contraception during the study in both men and women
Descripción

Contraceptive methods Quantity | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0079399
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous interferon or ribavirin therapy
Descripción

interferon | Ribavirin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0733470
UMLS CUI [2]
C0035525
systemic antiviral therapy less than 24 weeks before first dose of study drug or expected need for this treatment any time during the study
Descripción

Antiviral Therapy Systemic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0280274
UMLS CUI [1,2]
C0205373
medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
Descripción

medical condition Associated with Chronic liver disease | Hemochromatosis | Hepatitis, Autoimmune | Alcoholic Liver Diseases | Exposure to toxin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0341439
UMLS CUI [2]
C0018995
UMLS CUI [3]
C0241910
UMLS CUI [4]
C0023896
UMLS CUI [5]
C0040537
decompensated liver disease
Descripción

Decompensated liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4075847
women who are pregnant or breastfeeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Hepatitis C, Chronic NCT00107653

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients 18-65 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic hepatitis C genotype 1
Item
chc, genotype 1
boolean
C4049392 (UMLS CUI [1])
Chronic Hepatitis C Evidence Serologic | Antibody test
Item
serologic evidence of chc infection by an antibody test
boolean
C0524910 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
C0580327 (UMLS CUI [2])
Chronic liver disease Consistent with Hepatitis C, Chronic | Biopsy of liver
Item
chronic liver disease, consistent with chc infection on a liver biopsy obtained within the past 18 months
boolean
C0341439 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C0193388 (UMLS CUI [2])
Compensated liver disease
Item
compensated liver disease
boolean
C3839044 (UMLS CUI [1])
Contraceptive methods Quantity | Gender
Item
use of 2 forms of contraception during the study in both men and women
boolean
C0700589 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
interferon | Ribavirin
Item
previous interferon or ribavirin therapy
boolean
C0733470 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
Antiviral Therapy Systemic
Item
systemic antiviral therapy less than 24 weeks before first dose of study drug or expected need for this treatment any time during the study
boolean
C0280274 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
medical condition Associated with Chronic liver disease | Hemochromatosis | Hepatitis, Autoimmune | Alcoholic Liver Diseases | Exposure to toxin
Item
medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C0018995 (UMLS CUI [2])
C0241910 (UMLS CUI [3])
C0023896 (UMLS CUI [4])
C0040537 (UMLS CUI [5])
Decompensated liver disease
Item
decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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