ID
4580
Beschreibung
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
Stichworte
Versionen (1)
- 11.12.13 11.12.13 - Martin Dugas
Hochgeladen am
11. Dezember 2013
DOI
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Lizenz
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00087646 Hepatitis C
Eligibility
- StudyEvent: Eligibility
Beschreibung
Exclusion criteria
Beschreibung
Pregnancy / Lactation
Datentyp
boolean
Beschreibung
Pregnant partners
Datentyp
boolean
Beschreibung
Decompensated liver disease
Datentyp
boolean
Beschreibung
Other liver disease
Datentyp
boolean
Beschreibung
HIV
Datentyp
boolean
Beschreibung
Medical Concepts
Beschreibung
Age
Datentyp
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Beschreibung
Diagnosis
Datentyp
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
Beschreibung
CHC
Datentyp
string
Alias
- UMLS CUI
- C0524910
- SNOMED CT 2010_0731
- 128302006
- MedDRA 13.1
- 10008912
Beschreibung
Diagnostic procedure
Datentyp
string
Alias
- UMLS CUI
- C0430022
- SNOMED CT 2010_0731
- 103693007
- MedDRA 13.1
- 10061816
Beschreibung
Contraception
Datentyp
string
Alias
- UMLS CUI
- C0700589
- SNOMED CT 2010_0731
- 146680009
- MedDRA 13.1
- 10010808
Beschreibung
Pharmaceutical Preparations
Datentyp
string
Alias
- UMLS CUI
- C0013227
Beschreibung
pregnant
Datentyp
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Beschreibung
Lactation
Datentyp
string
Alias
- UMLS CUI
- C0006147
- MedDRA 13.1
- 10006247
Beschreibung
Advanced chronic liver disease
Datentyp
string
Alias
- UMLS CUI
- C0860197
- MedDRA 13.1
- 10001422
Beschreibung
HIV negative
Datentyp
string
Alias
- UMLS CUI
- C0481430
- SNOMED CT 2010_0731
- 143223008
- MedDRA 13.1
- 10020179
Ähnliche Modelle
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)