ID

4580

Description

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

Mots-clés

  1. 11/12/2013 11/12/2013 - Martin Dugas
Téléchargé le

11 décembre 2013

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00087646 Hepatitis C

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Description

Einschlusskriterien

Age
Description

Age

Type de données

boolean

Chronic Hepatitis C
Description

Chronic Hepatitis C

Type de données

boolean

Liver biopsy
Description

Liver biopsy

Type de données

boolean

Contraception men and women
Description

Contraception men and women

Type de données

boolean

Previous medication
Description

Previous medication

Type de données

boolean

Ausschlusskriterien
Description

Ausschlusskriterien

Pregnancy / Lactation
Description

Pregnancy / Lactation

Type de données

boolean

Pregnant partners
Description

Pregnant partners

Type de données

boolean

Decompensated liver disease
Description

Decompensated liver disease

Type de données

boolean

Other liver disease
Description

Other liver disease

Type de données

boolean

HIV
Description

HIV

Type de données

boolean

Medizinische Konzepte
Description

Medizinische Konzepte

Age
Description

Age

Type de données

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Description

Diagnosis

Type de données

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
CHC
Description

CHC

Type de données

string

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

Diagnostic procedure

Type de données

string

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

Contraception

Type de données

string

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

Pharmaceutical Preparations

Type de données

string

Alias
UMLS CUI
C0013227
pregnant
Description

pregnant

Type de données

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Lactation
Description

Lactation

Type de données

string

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

Advanced chronic liver disease

Type de données

string

Alias
UMLS CUI
C0860197
MedDRA 13.1
10001422
HIV negative
Description

HIV negative

Type de données

string

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

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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