ID

4580

Descripción

A Randomized, Open-label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous Pegintron/Ribavirin Combination Therapy Inclusion Criteria - adult patients >=18 years of age - CHC infection - liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection - use of 2 forms of contraception during study and 6 months after the study in both men and women - Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for >=12 weeks Exclusion Criteria - women who are pregnant or breastfeeding - male partners of women who are pregnant - conditions associated with decompensated liver disease - other forms of liver disease, including liver cancer - human immunodeficiency virus infection

Palabras clave

Versiones (1)
  1. 11/12/13 11/12/13 - Martin Dugas
Subido en

11 de diciembre de 2013

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00087646 Hepatitis C

Alemán Inglés

Eligibility

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Descripción

Inclusion criteria

adult patients >=18 years of age
Descripción

Age

Tipo de datos

boolean

CHC infection
Descripción

Chronic Hepatitis C

Tipo de datos

boolean

liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection
Descripción

Liver biopsy

Tipo de datos

boolean

use of 2 forms of contraception during study and 6 months after the study in both men and women
Descripción

Contraception men and women

Tipo de datos

boolean

Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for >=12 weeks
Descripción

Previous medication

Tipo de datos

boolean

Exclusion criteria
Descripción

Exclusion criteria

women who are pregnant or breastfeeding
Descripción

Pregnancy / Lactation

Tipo de datos

boolean

male partners of women who are pregnant
Descripción

Pregnant partners

Tipo de datos

boolean

conditions associated with decompensated liver disease
Descripción

Decompensated liver disease

Tipo de datos

boolean

other forms of liver disease, including liver cancer
Descripción

Other liver disease

Tipo de datos

boolean

human immunodeficiency virus infection
Descripción

HIV

Tipo de datos

boolean

Medical Concepts
Descripción

Medical Concepts

Age
Descripción

Age

Tipo de datos

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Descripción

Diagnosis

Tipo de datos

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
Chronic hepatitis C
Descripción

CHC

Tipo de datos

string

Alias
UMLS CUI
C0524910
SNOMED CT 2010_0731
128302006
MedDRA 13.1
10008912
Diagnostic procedure
Descripción

Diagnostic procedure

Tipo de datos

string

Alias
UMLS CUI
C0430022
SNOMED CT 2010_0731
103693007
MedDRA 13.1
10061816
Contraception
Descripción

Contraception

Tipo de datos

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Medication
Descripción

Pharmaceutical Preparations

Tipo de datos

string

Alias
UMLS CUI
C0013227
pregnant
Descripción

pregnant

Tipo de datos

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding
Descripción

Lactation

Tipo de datos

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Advanced chronic liver disease
Descripción

Advanced chronic liver disease

Tipo de datos

string

Alias
UMLS CUI
C0860197
MedDRA 13.1
10001422
HIV negative
Descripción

HIV negative

Tipo de datos

string

Alias
UMLS CUI
C0481430
SNOMED CT 2010_0731
143223008
MedDRA 13.1
10020179
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Similar models

Eligibility

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion criteria
Age
Item
adult patients >=18 years of age
boolean
Chronic Hepatitis C
Item
CHC infection
boolean
Liver biopsy
Item
liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection
boolean
Contraception men and women
Item
use of 2 forms of contraception during study and 6 months after the study in both men and women
boolean
Previous medication
Item
Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for >=12 weeks
boolean
Item Group
Exclusion criteria
Pregnancy / Lactation
Item
women who are pregnant or breastfeeding
boolean
Pregnant partners
Item
male partners of women who are pregnant
boolean
Decompensated liver disease
Item
conditions associated with decompensated liver disease
boolean
Other liver disease
Item
other forms of liver disease, including liver cancer
boolean
HIV
Item
human immunodeficiency virus infection
boolean
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
CHC
Item
Chronic hepatitis C
string
C0524910 (UMLS CUI)
128302006 (SNOMED CT 2010_0731)
10008912 (MedDRA 13.1)
Diagnostic procedure
Item
Diagnostic procedure
string
C0430022 (UMLS CUI)
103693007 (SNOMED CT 2010_0731)
10061816 (MedDRA 13.1)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Advanced chronic liver disease
Item
Advanced chronic liver disease
string
C0860197 (UMLS CUI)
10001422 (MedDRA 13.1)
HIV negative
Item
HIV negative
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
10020179 (MedDRA 13.1)
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