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
Versioner (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
- StudyEvent: Eligibility
Beskrivning
Ausschlusskriterien
Beskrivning
Pregnancy / Lactation
Datatyp
boolean
Beskrivning
Pregnant partners
Datatyp
boolean
Beskrivning
Decompensated liver disease
Datatyp
boolean
Beskrivning
Other liver disease
Datatyp
boolean
Beskrivning
HIV
Datatyp
boolean
Beskrivning
Medizinische Konzepte
Beskrivning
Age
Datatyp
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Beskrivning
Diagnosis
Datatyp
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
Beskrivning
CHC
Datatyp
string
Alias
- UMLS CUI
- C0524910
- SNOMED CT 2010_0731
- 128302006
- MedDRA 13.1
- 10008912
Beskrivning
Diagnostic procedure
Datatyp
string
Alias
- UMLS CUI
- C0430022
- SNOMED CT 2010_0731
- 103693007
- MedDRA 13.1
- 10061816
Beskrivning
Contraception
Datatyp
string
Alias
- UMLS CUI
- C0700589
- SNOMED CT 2010_0731
- 146680009
- MedDRA 13.1
- 10010808
Beskrivning
Pharmaceutical Preparations
Datatyp
string
Alias
- UMLS CUI
- C0013227
Beskrivning
pregnant
Datatyp
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Beskrivning
Lactation
Datatyp
string
Alias
- UMLS CUI
- C0006147
- MedDRA 13.1
- 10006247
Beskrivning
Advanced chronic liver disease
Datatyp
string
Alias
- UMLS CUI
- C0860197
- MedDRA 13.1
- 10001422
Beskrivning
HIV negative
Datatyp
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)
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