ID

33814

Description

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

Lien

https://clinicaltrials.gov/show/NCT01281839

Mots-clés

  1. 28/12/2018 28/12/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

28 décembre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

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Eligibility Hepatitis C NCT01281839

Eligibility Hepatitis C NCT01281839

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
genotype 1 hepatitis c infection (confirmed at screening)
Description

Hepatitis C Genotype

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0017431
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
Description

PEGINTERFERON | Hepatitis C virus RNA Documented | Recurrent disease

Type de données

boolean

Alias
UMLS CUI [1]
C0982327
UMLS CUI [2,1]
C0369335
UMLS CUI [2,2]
C1301725
UMLS CUI [3]
C0277556
liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis c infection
Description

Chronic Hepatitis C Biopsy of liver

Type de données

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0193388
must agree to use 2 forms of effective contraception throughout study (both males and females)
Description

Contraceptive methods Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
infection with hiv or non-genotype 1 hepatitis c
Description

HIV Infection | Hepatitis C Except Genotype 1

Type de données

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C3532919
liver disease not related to hepatitic c infection
Description

Liver disease | Relationship Absent Hepatitis C

Type de données

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0019196
hepatic decompensation
Description

Hepatic decompensation

Type de données

boolean

Alias
UMLS CUI [1]
C1394798
significant laboratory abnormalities or other active diseases
Description

Laboratory test result abnormal | Disease Other

Type de données

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205394
pregnant or planning to become pregnant
Description

Pregnancy | Pregnancy, Planned

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992

Similar models

Eligibility Hepatitis C NCT01281839

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C Genotype
Item
genotype 1 hepatitis c infection (confirmed at screening)
boolean
C0019196 (UMLS CUI [1,1])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
Pregnancy | Pregnancy, Planned
Item
pregnant or planning to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])

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