Informatie:
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ID
33814
Beschrijving
An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01281839
Link
https://clinicaltrials.gov/show/NCT01281839
Trefwoorden
Versies (1)
- 28-12-18 28-12-18 -
Houder van rechten
See clinicaltrials.gov
Geüploaded op
28 december 2018
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01281839
Eligibility Hepatitis C NCT01281839
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C NCT01281839
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Hepatitis C Genotype
Item
genotype 1 hepatitis c infection (confirmed at screening)
boolean
C0019196 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C0017431 (UMLS CUI [1,2])
PEGINTERFERON | Hepatitis C virus RNA Documented | Recurrent disease
Item
have previously received peginterferon-based therapy for at least 24 weeks with documented hcv rna at last measurement and relapsed within 1 year of last taking medication
boolean
C0982327 (UMLS CUI [1])
C0369335 (UMLS CUI [2,1])
C1301725 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3])
C0369335 (UMLS CUI [2,1])
C1301725 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3])
Chronic Hepatitis C Biopsy of liver
Item
liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis c infection
boolean
C0524910 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
Contraceptive methods Quantity
Item
must agree to use 2 forms of effective contraception throughout study (both males and females)
boolean
C0700589 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
HIV Infection | Hepatitis C Except Genotype 1
Item
infection with hiv or non-genotype 1 hepatitis c
boolean
C0019693 (UMLS CUI [1])
C0019196 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C3532919 (UMLS CUI [2,3])
C0019196 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C3532919 (UMLS CUI [2,3])
Liver disease | Relationship Absent Hepatitis C
Item
liver disease not related to hepatitic c infection
boolean
C0023895 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
Hepatic decompensation
Item
hepatic decompensation
boolean
C1394798 (UMLS CUI [1])
Laboratory test result abnormal | Disease Other
Item
significant laboratory abnormalities or other active diseases
boolean
C0438215 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Pregnancy | Pregnancy, Planned
Item
pregnant or planning to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0032992 (UMLS CUI [2])