ID

29706

Descripción

A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00720434

Link

https://clinicaltrials.gov/show/NCT00720434

Palabras clave

Versiones (1)
  1. 14/4/18 14/4/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

14 de abril de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00720434

Inglés

Eligibility Hepatitis C NCT00720434

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
treatment naive (no prior treatment with ifn-a +/- rbv regimens.
Descripción

Therapy naive | Interferon-alpha Absent | Ribavirin Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0002199
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0035525
UMLS CUI [3,2]
C0332197
subjects who have discontinued ifn-a containing regimens after <2 weeks of therapy due to tolerability issues are considered treatment naive.
Descripción

Interferon-alpha Discontinued | Drug Tolerance Issue

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0002199
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0013220
UMLS CUI [2,2]
C0033213
hcv rna > 100,000 iu/ml at screening.
Descripción

Hepatitis C virus RNA assay

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272251
genotype 1.
Descripción

Genotype determination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1533728
a diagnosis of chronic hcv infection for at least 6 months.
Descripción

Hepatitis C, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0524910
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of acute or chronic infection with hiv or hbv.
Descripción

HIV Infection | Hepatitis B | Chronic infection with HIV | Hepatitis B, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0853112
UMLS CUI [4]
C0524909
exposure within the previous three months to an investigational anti-hcv agent.
Descripción

Exposure to Investigational New Drugs Against Hepatitis C virus

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0521124
UMLS CUI [1,4]
C0220847
evidence of severe or decompensated liver disease.
Descripción

Liver disease Severe | Decompensated liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C4075847
subjects with liver disease unrelated to hcv infection.
Descripción

Liver disease | Exception Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
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Similar models

Eligibility Hepatitis C NCT00720434

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Therapy naive | Interferon-alpha Absent | Ribavirin Absent
Item
treatment naive (no prior treatment with ifn-a +/- rbv regimens.
boolean
C0919936 (UMLS CUI [1])
C0002199 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0035525 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Interferon-alpha Discontinued | Drug Tolerance Issue
Item
subjects who have discontinued ifn-a containing regimens after <2 weeks of therapy due to tolerability issues are considered treatment naive.
boolean
C0002199 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0013220 (UMLS CUI [2,1])
C0033213 (UMLS CUI [2,2])
Hepatitis C virus RNA assay
Item
hcv rna > 100,000 iu/ml at screening.
boolean
C1272251 (UMLS CUI [1])
Genotype determination
Item
genotype 1.
boolean
C1533728 (UMLS CUI [1])
Hepatitis C, Chronic
Item
a diagnosis of chronic hcv infection for at least 6 months.
boolean
C0524910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HIV Infection | Hepatitis B | Chronic infection with HIV | Hepatitis B, Chronic
Item
evidence of acute or chronic infection with hiv or hbv.
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0853112 (UMLS CUI [3])
C0524909 (UMLS CUI [4])
Exposure to Investigational New Drugs Against Hepatitis C virus
Item
exposure within the previous three months to an investigational anti-hcv agent.
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0521124 (UMLS CUI [1,3])
C0220847 (UMLS CUI [1,4])
Liver disease Severe | Decompensated liver disease
Item
evidence of severe or decompensated liver disease.
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4075847 (UMLS CUI [2])
Liver disease | Exception Hepatitis C
Item
subjects with liver disease unrelated to hcv infection.
boolean
C0023895 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Volver a la parte superior de la página 

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