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
Keywords
Versions (1)
- 12/11/13 12/11/13 - Martin Dugas
Uploaded on
December 11, 2013
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00087646 Hepatitis C
Eligibility
- StudyEvent: Eligibility
Description
Exclusion criteria
Description
Pregnancy / Lactation
Data type
boolean
Description
Pregnant partners
Data type
boolean
Description
Decompensated liver disease
Data type
boolean
Description
Other liver disease
Data type
boolean
Description
HIV
Data type
boolean
Description
Medical Concepts
Description
Age
Data type
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Description
Diagnosis
Data type
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
Description
CHC
Data type
string
Alias
- UMLS CUI
- C0524910
- SNOMED CT 2010_0731
- 128302006
- MedDRA 13.1
- 10008912
Description
Diagnostic procedure
Data type
string
Alias
- UMLS CUI
- C0430022
- SNOMED CT 2010_0731
- 103693007
- MedDRA 13.1
- 10061816
Description
Contraception
Data type
string
Alias
- UMLS CUI
- C0700589
- SNOMED CT 2010_0731
- 146680009
- MedDRA 13.1
- 10010808
Description
Pharmaceutical Preparations
Data type
string
Alias
- UMLS CUI
- C0013227
Description
pregnant
Data type
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Description
Lactation
Data type
string
Alias
- UMLS CUI
- C0006147
- MedDRA 13.1
- 10006247
Description
Advanced chronic liver disease
Data type
string
Alias
- UMLS CUI
- C0860197
- MedDRA 13.1
- 10001422
Description
HIV negative
Data type
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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