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
Versies (1)
- 11-12-13 11-12-13 - Martin Dugas
Geüploaded op
11 december 2013
DOI
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Licentie
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00087646 Hepatitis C
Eligibility
- StudyEvent: Eligibility
Beschrijving
Exclusion criteria
Beschrijving
Pregnancy / Lactation
Datatype
boolean
Beschrijving
Pregnant partners
Datatype
boolean
Beschrijving
Decompensated liver disease
Datatype
boolean
Beschrijving
Other liver disease
Datatype
boolean
Beschrijving
HIV
Datatype
boolean
Beschrijving
Medical Concepts
Beschrijving
Age
Datatype
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Beschrijving
Diagnosis
Datatype
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
Beschrijving
CHC
Datatype
string
Alias
- UMLS CUI
- C0524910
- SNOMED CT 2010_0731
- 128302006
- MedDRA 13.1
- 10008912
Beschrijving
Diagnostic procedure
Datatype
string
Alias
- UMLS CUI
- C0430022
- SNOMED CT 2010_0731
- 103693007
- MedDRA 13.1
- 10061816
Beschrijving
Contraception
Datatype
string
Alias
- UMLS CUI
- C0700589
- SNOMED CT 2010_0731
- 146680009
- MedDRA 13.1
- 10010808
Beschrijving
Pharmaceutical Preparations
Datatype
string
Alias
- UMLS CUI
- C0013227
Beschrijving
pregnant
Datatype
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Beschrijving
Lactation
Datatype
string
Alias
- UMLS CUI
- C0006147
- MedDRA 13.1
- 10006247
Beschrijving
Advanced chronic liver disease
Datatype
string
Alias
- UMLS CUI
- C0860197
- MedDRA 13.1
- 10001422
Beschrijving
HIV negative
Datatype
string
Alias
- UMLS CUI
- C0481430
- SNOMED CT 2010_0731
- 143223008
- MedDRA 13.1
- 10020179
Similar models
Eligibility
- StudyEvent: Eligibility
102518004 (SNOMED CT 2010_0731)
439401001 (SNOMED CT 2010_0731)
128302006 (SNOMED CT 2010_0731)
10008912 (MedDRA 13.1)
103693007 (SNOMED CT 2010_0731)
10061816 (MedDRA 13.1)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
10036586 (MedDRA 13.1)
10006247 (MedDRA 13.1)
10001422 (MedDRA 13.1)
143223008 (SNOMED CT 2010_0731)
10020179 (MedDRA 13.1)