ID

20446

Descripción

An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants; ODM derived from: https://clinicaltrials.gov/show/NCT00528528

Link

https://clinicaltrials.gov/show/NCT00528528

Palabras clave

Versiones (1)
  1. 22/2/17 22/2/17 -
Subido en

22 de febrero de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00528528

Inglés

Eligibility Chronic Hepatitis C NCT00528528

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic genotype 1 hepatitis (inflammation of the liver) c infection
Descripción

chronic hepatitis c, genotype 1

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C3532919
never been treated for hepatitis c viral (hcv) infection
Descripción

Did not receive therapy or drug for; Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332155
UMLS CUI [1,2]
C0019196
no clinically significant lab abnormalities
Descripción

laboratory normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0586624
amount of hcv ribonucleic acid (rna) in the blood more than 10,000 international units/milliliter (iu/ml) at entry
Descripción

hcv rna

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0369335
liver biopsy or "fibroscan" test performed during screening or in the past 3 years
Descripción

liver biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0193388
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
contra-indications for starting anti-hcv therapy
Descripción

contraindication for starting anti-hcv therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C4020634
history or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease
Descripción

Medical History; Liver Cirrhosis; Decompensated liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0023890
UMLS CUI [1,3]
C4075847
any evidence of significant liver disease in addition to hepatitis c
Descripción

comorbidity, liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0023895
infected with human immunodeficiency virus (a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) or hepatitis b
Descripción

hiv, hep b

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
women who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding or the partner of a woman who is pregnant or breastfeeding
Descripción

Pregnancy; Childbearing Potential; Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0006147
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Similar models

Eligibility Chronic Hepatitis C NCT00528528

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
chronic hepatitis c, genotype 1
Item
chronic genotype 1 hepatitis (inflammation of the liver) c infection
boolean
C0524910 (UMLS CUI [1,1])
C3532919 (UMLS CUI [1,2])
Did not receive therapy or drug for; Hepatitis C
Item
never been treated for hepatitis c viral (hcv) infection
boolean
C0332155 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
laboratory normal
Item
no clinically significant lab abnormalities
boolean
C0586624 (UMLS CUI [1])
hcv rna
Item
amount of hcv ribonucleic acid (rna) in the blood more than 10,000 international units/milliliter (iu/ml) at entry
boolean
C0369335 (UMLS CUI [1])
liver biopsy
Item
liver biopsy or "fibroscan" test performed during screening or in the past 3 years
boolean
C0193388 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
contraindication for starting anti-hcv therapy
Item
contra-indications for starting anti-hcv therapy
boolean
C1301624 (UMLS CUI [1,1])
C4020634 (UMLS CUI [1,2])
Medical History; Liver Cirrhosis; Decompensated liver disease
Item
history or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease
boolean
C0262926 (UMLS CUI [1,1])
C0023890 (UMLS CUI [1,2])
C4075847 (UMLS CUI [1,3])
comorbidity, liver disease
Item
any evidence of significant liver disease in addition to hepatitis c
boolean
C0009488 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
hiv, hep b
Item
infected with human immunodeficiency virus (a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) or hepatitis b
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
Pregnancy; Childbearing Potential; Breast Feeding
Item
women who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding or the partner of a woman who is pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,3])
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