ID

21182

Description

Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding (1) Subjects With HCV Genotype 1 and High Viral Load, and (2) Interferon-naïve Subjects With Low Viral Load (Study P04841)(COMPLETED); ODM derived from: https://clinicaltrials.gov/show/NCT00724230

Link

https://clinicaltrials.gov/show/NCT00724230

Keywords

Versions (1)
  1. 4/12/17 4/12/17 -
Uploaded on

April 12, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00724230

English

Eligibility Hepatitis C, Chronic NCT00724230

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with chronic hepatitis c
Description

Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0524910
among interferon-naïve patients, only patients with high viral load and hcv genotype other than 1
Description

Interferon-therapy, viral load, HCV genotype

Data type

boolean

Alias
UMLS CUI [1]
C0279030
UMLS CUI [2]
C1261478
UMLS CUI [3]
C1148363
among prior nonresponders or relapsers to interferon monotherapy, (1) patients with high viral load and hcv genotype other than 1; and (2) patients with low viral load of all genotypes (including genotype 1)
Description

Nonresponder to Interferon-therapy, viral load, HCV genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C3844724
UMLS CUI [1,2]
C0279030
UMLS CUI [2]
C1261478
UMLS CUI [3]
C1148363
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients infected with hcv genotype 1 with high viral load, regardless of whether treatment-naïve or previous nonresponders/relapsers
Description

HCV Genotype 1 and viral load

Data type

boolean

Alias
UMLS CUI [1,1]
C3532919
UMLS CUI [1,2]
C1261478
interferon-naïve patients with low viral load
Description

Interferon therapy and viral load

Data type

boolean

Alias
UMLS CUI [1,1]
C0279030
UMLS CUI [1,2]
C1261478
patients with a history of hypersensitivity to test drugs or other interferon preparations
Description

ID.6

Data type

boolean

patients with a history of hypersensitivity to biological products, such as vaccines
Description

Hypersensitivity to biological products

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0005522
patients being treated with shosaikoto
Description

Shosaikoto

Data type

boolean

Alias
UMLS CUI [1]
C1138004
patients with autoimmune hepatitis
Description

Autoimmune hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0241910
pregnant women, women who may be pregnant, and nursing mothers
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.)
Description

Hypersensitivity to nucleoside analogs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1579410
patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)
Description

Uncontrolled cardiac disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)
Description

Hemoglobinopathies

Data type

boolean

Alias
UMLS CUI [1]
C0019045
patients with chronic renal failure or renal function disorder with creatinine clearance of <=50 ml/min
Description

Cronic renal failure or Creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0373595
patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt
Description

Severe psychiatric condition

Data type

boolean

Alias
UMLS CUI [1]
C4046029
patients with serious hepatic dysfunction
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
patients with autoimmune hepatitis
Description

Autoimmune hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0241910
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Similar models

Eligibility Hepatitis C, Chronic NCT00724230

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C
Item
patients diagnosed with chronic hepatitis c
boolean
C0524910 (UMLS CUI [1])
Interferon-therapy, viral load, HCV genotype
Item
among interferon-naïve patients, only patients with high viral load and hcv genotype other than 1
boolean
C0279030 (UMLS CUI [1])
C1261478 (UMLS CUI [2])
C1148363 (UMLS CUI [3])
Nonresponder to Interferon-therapy, viral load, HCV genotype
Item
among prior nonresponders or relapsers to interferon monotherapy, (1) patients with high viral load and hcv genotype other than 1; and (2) patients with low viral load of all genotypes (including genotype 1)
boolean
C3844724 (UMLS CUI [1,1])
C0279030 (UMLS CUI [1,2])
C1261478 (UMLS CUI [2])
C1148363 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
HCV Genotype 1 and viral load
Item
patients infected with hcv genotype 1 with high viral load, regardless of whether treatment-naïve or previous nonresponders/relapsers
boolean
C3532919 (UMLS CUI [1,1])
C1261478 (UMLS CUI [1,2])
Interferon therapy and viral load
Item
interferon-naïve patients with low viral load
boolean
C0279030 (UMLS CUI [1,1])
C1261478 (UMLS CUI [1,2])
ID.6
Item
patients with a history of hypersensitivity to test drugs or other interferon preparations
boolean
Hypersensitivity to biological products
Item
patients with a history of hypersensitivity to biological products, such as vaccines
boolean
C0020517 (UMLS CUI [1,1])
C0005522 (UMLS CUI [1,2])
Shosaikoto
Item
patients being treated with shosaikoto
boolean
C1138004 (UMLS CUI [1])
Autoimmune hepatitis
Item
patients with autoimmune hepatitis
boolean
C0241910 (UMLS CUI [1])
Gynaecological status
Item
pregnant women, women who may be pregnant, and nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Hypersensitivity to nucleoside analogs
Item
patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.)
boolean
C0020517 (UMLS CUI [1,1])
C1579410 (UMLS CUI [1,2])
Uncontrolled cardiac disease
Item
patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Hemoglobinopathies
Item
patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)
boolean
C0019045 (UMLS CUI [1])
Cronic renal failure or Creatinine clearance
Item
patients with chronic renal failure or renal function disorder with creatinine clearance of <=50 ml/min
boolean
C0022661 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Severe psychiatric condition
Item
patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt
boolean
C4046029 (UMLS CUI [1])
Liver function
Item
patients with serious hepatic dysfunction
boolean
C0232741 (UMLS CUI [1])
Autoimmune hepatitis
Item
patients with autoimmune hepatitis
boolean
C0241910 (UMLS CUI [1])
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