ID

4580

Beskrivning

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

Nyckelord

  1. 2013-12-11 2013-12-11 - Martin Dugas
Uppladdad den

11 december 2013

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00087646 Hepatitis C

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

Age
Beskrivning

Age

Datatyp

boolean

Chronic Hepatitis C
Beskrivning

Chronic Hepatitis C

Datatyp

boolean

Liver biopsy
Beskrivning

Liver biopsy

Datatyp

boolean

Contraception men and women
Beskrivning

Contraception men and women

Datatyp

boolean

Previous medication
Beskrivning

Previous medication

Datatyp

boolean

Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Pregnancy / Lactation
Beskrivning

Pregnancy / Lactation

Datatyp

boolean

Pregnant partners
Beskrivning

Pregnant partners

Datatyp

boolean

Decompensated liver disease
Beskrivning

Decompensated liver disease

Datatyp

boolean

Other liver disease
Beskrivning

Other liver disease

Datatyp

boolean

HIV
Beskrivning

HIV

Datatyp

boolean

Medizinische Konzepte
Beskrivning

Medizinische Konzepte

Age
Beskrivning

Age

Datatyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Beskrivning

Diagnosis

Datatyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
CHC
Beskrivning

CHC

Datatyp

string

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

Diagnostic procedure

Datatyp

string

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

Contraception

Datatyp

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Pharmaceutical Preparations
Beskrivning

Pharmaceutical Preparations

Datatyp

string

Alias
UMLS CUI
C0013227
pregnant
Beskrivning

pregnant

Datatyp

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Lactation
Beskrivning

Lactation

Datatyp

string

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

Advanced chronic liver disease

Datatyp

string

Alias
UMLS CUI
C0860197
MedDRA 13.1
10001422
HIV negative
Beskrivning

HIV negative

Datatyp

string

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

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
Age
Item
boolean
Chronic Hepatitis C
Item
boolean
Liver biopsy
Item
boolean
Contraception men and women
Item
boolean
Previous medication
Item
boolean
Item Group
Ausschlusskriterien
Pregnancy / Lactation
Item
boolean
Pregnant partners
Item
boolean
Decompensated liver disease
Item
boolean
Other liver disease
Item
boolean
HIV
Item
boolean
Item Group
Medizinische Konzepte
Age
Item
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
CHC
Item
string
C0524910 (UMLS CUI)
128302006 (SNOMED CT 2010_0731)
10008912 (MedDRA 13.1)
Diagnostic procedure
Item
string
C0430022 (UMLS CUI)
103693007 (SNOMED CT 2010_0731)
10061816 (MedDRA 13.1)
Contraception
Item
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Pharmaceutical Preparations
Item
string
C0013227 (UMLS CUI)
pregnant
Item
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Advanced chronic liver disease
Item
string
C0860197 (UMLS CUI)
10001422 (MedDRA 13.1)
HIV negative
Item
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
10020179 (MedDRA 13.1)

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