ID

4580

Beschrijving

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

Trefwoorden

  1. 11-12-13 11-12-13 - Martin Dugas
Geüploaded op

11 december 2013

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0 Legacy

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility NCT00087646 Hepatitis C

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Beschrijving

Inclusion criteria

adult patients >=18 years of age
Beschrijving

Age

Datatype

boolean

CHC infection
Beschrijving

Chronic Hepatitis C

Datatype

boolean

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

Liver biopsy

Datatype

boolean

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

Contraception men and women

Datatype

boolean

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

Previous medication

Datatype

boolean

Exclusion criteria
Beschrijving

Exclusion criteria

women who are pregnant or breastfeeding
Beschrijving

Pregnancy / Lactation

Datatype

boolean

male partners of women who are pregnant
Beschrijving

Pregnant partners

Datatype

boolean

conditions associated with decompensated liver disease
Beschrijving

Decompensated liver disease

Datatype

boolean

other forms of liver disease, including liver cancer
Beschrijving

Other liver disease

Datatype

boolean

human immunodeficiency virus infection
Beschrijving

HIV

Datatype

boolean

Medical Concepts
Beschrijving

Medical Concepts

Age
Beschrijving

Age

Datatype

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Beschrijving

Diagnosis

Datatype

string

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

CHC

Datatype

string

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

Diagnostic procedure

Datatype

string

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

Contraception

Datatype

string

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

Pharmaceutical Preparations

Datatype

string

Alias
UMLS CUI
C0013227
pregnant
Beschrijving

pregnant

Datatype

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding
Beschrijving

Lactation

Datatype

string

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

Advanced chronic liver disease

Datatype

string

Alias
UMLS CUI
C0860197
MedDRA 13.1
10001422
HIV negative
Beschrijving

HIV negative

Datatype

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)
Datatype
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)

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial