ID

20979

Description

Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED); ODM derived from: https://clinicaltrials.gov/show/NCT00787371

Link

https://clinicaltrials.gov/show/NCT00787371

Keywords

Versions (1)
  1. 4/1/17 4/1/17 -
Uploaded on

April 1, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00787371

English

Eligibility Hepatitis C, Chronic NCT00787371

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with chronic hepatitis c patients (chc) who met all of the following criteria:
Description

Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524910
at least 20 years of age and willing to sign an informed consent
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
patients who can practice contraception
Description

Contraceptive methods Use of

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1524063
patients who are classified either as relapsers or non-responders.
Description

Recurrent disease | Absent response to treatment

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0438286
weight between 45 and 100 kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
patients willing to be hospitalized for 3 days after the start of treatment
Description

Hospitalization Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0600109
patients with positive hcv-rna
Description

HCV viral load Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C1868902
UMLS CUI [1,2]
C1514241
serum alt level: over 60 iu/l, equal to or less than 150 iu/l
Description

Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
neutrophil count: equal to or more than 1,200 /mm^3
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count：equal to or more than 100,000/mm^3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with conditions which would interfere with the evaluation of therapeutic efficacy of the study drug and patients for whom assurance of safety is a concern were excluded from the study.
Description

Condition Interferes with research results | Study Subject Participation Status Exclusion Patient safety Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C2828389
UMLS CUI [2,3]
C1113679
UMLS CUI [2,4]
C0439849
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Similar models

Eligibility Hepatitis C, Chronic NCT00787371

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic
Item
patients with chronic hepatitis c patients (chc) who met all of the following criteria:
boolean
C0524910 (UMLS CUI [1])
Age | Informed Consent
Item
at least 20 years of age and willing to sign an informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Contraceptive methods Use of
Item
patients who can practice contraception
boolean
C0700589 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Recurrent disease | Absent response to treatment
Item
patients who are classified either as relapsers or non-responders.
boolean
C0277556 (UMLS CUI [1])
C0438286 (UMLS CUI [2])
Body Weight
Item
weight between 45 and 100 kg
boolean
C0005910 (UMLS CUI [1])
Hospitalization Willing
Item
patients willing to be hospitalized for 3 days after the start of treatment
boolean
C0019993 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
HCV viral load Positive
Item
patients with positive hcv-rna
boolean
C1868902 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Alanine aminotransferase measurement
Item
serum alt level: over 60 iu/l, equal to or less than 150 iu/l
boolean
C0201836 (UMLS CUI [1])
Absolute neutrophil count
Item
neutrophil count: equal to or more than 1,200 /mm^3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count：equal to or more than 100,000/mm^3
boolean
C0032181 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Condition Interferes with research results | Study Subject Participation Status Exclusion Patient safety Related
Item
patients with conditions which would interfere with the evaluation of therapeutic efficacy of the study drug and patients for whom assurance of safety is a concern were excluded from the study.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,4])
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