ID

39579

Description

Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed); ODM derived from: https://clinicaltrials.gov/show/NCT00725842

Link

https://clinicaltrials.gov/show/NCT00725842

Keywords

Versions (1)
  1. 1/31/20 1/31/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 31, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00725842

English

Eligibility Hepatitis C NCT00725842

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient must demonstrate his/her continued willingness to participate in the study.
Description

Study Subject Participation Status Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0600109
the patient must be at least 18 years of age, of either gender.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with chronic hepatitis c (any genotype) who received peg-ifn alfa-2b +
Description

Chronic Hepatitis C Genotype Any | peginterferon alfa-2b

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1148363
UMLS CUI [1,3]
C1552551
UMLS CUI [2]
C0796545
ribavirin as first treatment for hepatitis c.
Description

Ribavirin | Primary treatment Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0035525
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0019196
negative hcv-rna at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. only institutions using an assay with a limit of detection of 50 iu/ml or less will be eligible.
Description

Hepatitis C RNA negative Assay

Data type

boolean

Alias
UMLS CUI [1,1]
C0855841
UMLS CUI [1,2]
C1510438
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who completed treatment with peginterferon alfa-2b plus ribavirin more than 4 weeks before study entry.
Description

Treatment completed | Peginterferon alfa-2b Plus Ribavirin

Data type

boolean

Alias
UMLS CUI [1]
C0580352
UMLS CUI [2,1]
C0796545
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0035525
patients with positive hcv-rna at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
Description

Hepatitis C RNA positive | Treatment completed

Data type

boolean

Alias
UMLS CUI [1]
C0855842
UMLS CUI [2]
C0580352
patients treated for a period shorter than the enrollment period.
Description

Treatment Time period Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1948053
UMLS CUI [1,3]
C0205412
patients co-infected with human immunodeficiency virus (hiv).
Description

Human immunodeficiency virus (HIV) coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
patients co-infected with hepatitis b virus (hbv).
Description

HBV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C2242656
patients who do not use appropriate effective method of birth control after the end of treatment (according to legal recommendations).
Description

Contraceptive methods Inappropriate | Status post Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0087111
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Similar models

Eligibility Hepatitis C NCT00725842

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status Willing
Item
the patient must demonstrate his/her continued willingness to participate in the study.
boolean
C2348568 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Age
Item
the patient must be at least 18 years of age, of either gender.
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C Genotype Any | peginterferon alfa-2b
Item
patients with chronic hepatitis c (any genotype) who received peg-ifn alfa-2b +
boolean
C0524910 (UMLS CUI [1,1])
C1148363 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0796545 (UMLS CUI [2])
Ribavirin | Primary treatment Hepatitis C
Item
ribavirin as first treatment for hepatitis c.
boolean
C0035525 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Hepatitis C RNA negative Assay
Item
negative hcv-rna at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. only institutions using an assay with a limit of detection of 50 iu/ml or less will be eligible.
boolean
C0855841 (UMLS CUI [1,1])
C1510438 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Treatment completed | Peginterferon alfa-2b Plus Ribavirin
Item
patients who completed treatment with peginterferon alfa-2b plus ribavirin more than 4 weeks before study entry.
boolean
C0580352 (UMLS CUI [1])
C0796545 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
Hepatitis C RNA positive | Treatment completed
Item
patients with positive hcv-rna at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
boolean
C0855842 (UMLS CUI [1])
C0580352 (UMLS CUI [2])
Treatment Time period Inadequate
Item
patients treated for a period shorter than the enrollment period.
boolean
C0087111 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
Human immunodeficiency virus (HIV) coinfection
Item
patients co-infected with human immunodeficiency virus (hiv).
boolean
C4062778 (UMLS CUI [1])
HBV coinfection
Item
patients co-infected with hepatitis b virus (hbv).
boolean
C2242656 (UMLS CUI [1])
Contraceptive methods Inappropriate | Status post Treatment
Item
patients who do not use appropriate effective method of birth control after the end of treatment (according to legal recommendations).
boolean
C0700589 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
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