ID

44430

Descripción

A Study of the Pharmacokinetics And Pharmacodynamics of Intravenously Administered Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C And Previous Non-Response to Pegylated Interferon And Ribavirin Combination Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01337375

Link

https://clinicaltrials.gov/show/NCT01337375

Palabras clave

Versiones (2)
  1. 11/2/20 11/2/20 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01337375

Inglés

Eligibility Hepatitis C, Chronic NCT01337375

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult caucasian patients, 18 - 70 years of age
Descripción

Caucasians Adult | Age

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0043157
UMLS CUI [1,2]
C0001675
UMLS CUI [2]
C0001779
hepatitis c, genotype 1
Descripción

Hepatitis C Genotype

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
non-responder to previous anti-hcv therapy with peginterferon alfa and ribavirin
Descripción

Therapy non-responder Anti-HCV Agents | Therapy non-responder Peginterferon alfa-2a | Therapy non-responder Peginterferon alfa-2b | Therapy non-responder Ribavirin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0919875
UMLS CUI [1,2]
C4324240
UMLS CUI [2,1]
C0919875
UMLS CUI [2,2]
C0391001
UMLS CUI [3,1]
C0919875
UMLS CUI [3,2]
C0796545
UMLS CUI [4,1]
C0919875
UMLS CUI [4,2]
C0035525
compensated liver disease (child-pugh class a) for >/= 24 months before baseline
Descripción

Compensated liver disease Child-Pugh Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C4050412
positive for anti-hcv for > 6 months, with detectable serum hcv-rna
Descripción

Hepatitis C antibody positive | Serum Hepatitis C virus RNA Detectable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0281863
UMLS CUI [2,1]
C0229671
UMLS CUI [2,2]
C0369335
UMLS CUI [2,3]
C3830527
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment-naïve or responder to previous therapy
Descripción

Therapy naive | Responder Prior Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0919876
UMLS CUI [2,2]
C1514463
hcv infection other than genotype 1
Descripción

Hepatitis C | Exception Genotype determination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1533728
positive for hepatitis a, hepatitis b or hiv infection at screening
Descripción

Hepatitis A positive | Hepatitis B positive | HIV Seropositivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1112370
UMLS CUI [2]
C0856706
UMLS CUI [3]
C0019699
chronic hepatitis of other than hcv origin
Descripción

Hepatitis, Chronic | Etiology Except Hepatitis C virus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019189
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0220847
decompensated liver disease (child-pugh class b or c)
Descripción

Decompensated liver disease Child-Pugh Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C4050412
therapy with systemic antiviral, antineoplastic or immunomodulatory agents in the 6 months prior to study
Descripción

ANTIVIRALS FOR SYSTEMIC USE | Antineoplastic Agents Systemic | Immunomodulatory agents Systemic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3653777
UMLS CUI [2,1]
C0003392
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C0005525
UMLS CUI [3,2]
C0205373
clinically relevant retina disorder
Descripción

Retinal Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0035309
pregnant or lactating women and male partners of pregnant women
Descripción

Pregnancy | Breast Feeding | Gender Partner Pregnancy

Tipo de datos

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
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Similar models

Eligibility Hepatitis C, Chronic NCT01337375

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Caucasians Adult | Age
Item
adult caucasian patients, 18 - 70 years of age
boolean
C0043157 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Hepatitis C Genotype
Item
hepatitis c, genotype 1
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy non-responder Anti-HCV Agents | Therapy non-responder Peginterferon alfa-2a | Therapy non-responder Peginterferon alfa-2b | Therapy non-responder Ribavirin
Item
non-responder to previous anti-hcv therapy with peginterferon alfa and ribavirin
boolean
C0919875 (UMLS CUI [1,1])
C4324240 (UMLS CUI [1,2])
C0919875 (UMLS CUI [2,1])
C0391001 (UMLS CUI [2,2])
C0919875 (UMLS CUI [3,1])
C0796545 (UMLS CUI [3,2])
C0919875 (UMLS CUI [4,1])
C0035525 (UMLS CUI [4,2])
Compensated liver disease Child-Pugh Classification
Item
compensated liver disease (child-pugh class a) for >/= 24 months before baseline
boolean
C3839044 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Hepatitis C antibody positive | Serum Hepatitis C virus RNA Detectable
Item
positive for anti-hcv for > 6 months, with detectable serum hcv-rna
boolean
C0281863 (UMLS CUI [1])
C0229671 (UMLS CUI [2,1])
C0369335 (UMLS CUI [2,2])
C3830527 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Therapy naive | Responder Prior Therapy
Item
treatment-naïve or responder to previous therapy
boolean
C0919936 (UMLS CUI [1])
C0919876 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
Hepatitis C | Exception Genotype determination
Item
hcv infection other than genotype 1
boolean
C0019196 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
Hepatitis A positive | Hepatitis B positive | HIV Seropositivity
Item
positive for hepatitis a, hepatitis b or hiv infection at screening
boolean
C1112370 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Hepatitis, Chronic | Etiology Except Hepatitis C virus
Item
chronic hepatitis of other than hcv origin
boolean
C0019189 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
Decompensated liver disease Child-Pugh Classification
Item
decompensated liver disease (child-pugh class b or c)
boolean
C4075847 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
ANTIVIRALS FOR SYSTEMIC USE | Antineoplastic Agents Systemic | Immunomodulatory agents Systemic
Item
therapy with systemic antiviral, antineoplastic or immunomodulatory agents in the 6 months prior to study
boolean
C3653777 (UMLS CUI [1])
C0003392 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0005525 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
Retinal Disease
Item
clinically relevant retina disorder
boolean
C0035309 (UMLS CUI [1])
Pregnancy | Breast Feeding | Gender Partner Pregnancy
Item
pregnant or lactating women and male partners of pregnant women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
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