ID

20974

Description

Safety and Efficacy of PegIntron and Rebetol Combination Therapy in Patients With Chronic Hepatitis C in Japan (Study P04505); ODM derived from: https://clinicaltrials.gov/show/NCT00724295

Link

https://clinicaltrials.gov/show/NCT00724295

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 NCT00724295

English

Eligibility Hepatitis C, Chronic NCT00724295

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with chronic hepatitis c.
Description

Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524910
patients are serogroup 1(genotype i (1a) or ii (1b)).
Description

Hepatitis C virus Serogroup | Hepatitis C virus genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0220847
UMLS CUI [1,2]
C0449543
UMLS CUI [2]
C1148363
the hcv-rna level in the blood is more than 10^5 iu/ml by rt-pcr method, or 1meq./ml by b-dna method
Description

HCV viral load Level Reverse Transcriptase Polymerase Chain Reaction | HCV viral load Level Branched DNA Assay

Data type

boolean

Alias
UMLS CUI [1,1]
C1868902
UMLS CUI [1,2]
C0441889
UMLS CUI [1,3]
C0599161
UMLS CUI [2,1]
C1868902
UMLS CUI [2,2]
C0441889
UMLS CUI [2,3]
C0887812
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a history of hypersensitivity to test drugs or other interferon preparations
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Interferon

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C3652465
patients with a history of hypersensitivity to biological products, such as vaccines
Description

Hypersensitivity Biological Products | Vaccines allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0005522
UMLS CUI [2]
C0571550
patients being treated with shosaikoto
Description

shosaiko-to

Data type

boolean

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

Hepatitis, Autoimmune

Data type

boolean

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

Pregnancy | Possible pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
UMLS CUI [3]
C0006147
patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.)
Description

Hypersensitivity Investigational New Drug Component | Hypersensitivity Nucleoside Analogs | Aciclovir allergy | Ganciclovir allergy | Vidarabine allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1579410
UMLS CUI [3]
C0571297
UMLS CUI [4]
C0571283
UMLS CUI [5]
C0571296
patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)
Description

Heart Diseases CONTROL DIFFICULT | Myocardial Infarction | Heart failure | Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0742800
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0003811
patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)
Description

Hemoglobinopathies | Thalassemia | Anemia, Sickle Cell

Data type

boolean

Alias
UMLS CUI [1]
C0019045
UMLS CUI [2]
C0039730
UMLS CUI [3]
C0002895
patients with chronic renal failure or renal function disorder with creatinine clearance of <=50 ml/min
Description

Kidney Failure, Chronic | Renal function disorder | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0859242
UMLS CUI [3]
C0373595
patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt
Description

Mental Disorders, Severe | Severe depression | Feeling suicidal | Suicide attempt

Data type

boolean

Alias
UMLS CUI [1]
C4046029
UMLS CUI [2]
C0588008
UMLS CUI [3]
C0424000
UMLS CUI [4]
C0038663
patients with serious hepatic dysfunction
Description

Liver Dysfunction Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205404
patients with autoimmune hepatitis
Description

Hepatitis, Autoimmune

Data type

boolean

Alias
UMLS CUI [1]
C0241910
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Similar models

Eligibility Hepatitis C, Chronic NCT00724295

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.
boolean
C0524910 (UMLS CUI [1])
Hepatitis C virus Serogroup | Hepatitis C virus genotype
Item
patients are serogroup 1(genotype i (1a) or ii (1b)).
boolean
C0220847 (UMLS CUI [1,1])
C0449543 (UMLS CUI [1,2])
C1148363 (UMLS CUI [2])
HCV viral load Level Reverse Transcriptase Polymerase Chain Reaction | HCV viral load Level Branched DNA Assay
Item
the hcv-rna level in the blood is more than 10^5 iu/ml by rt-pcr method, or 1meq./ml by b-dna method
boolean
C1868902 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C0599161 (UMLS CUI [1,3])
C1868902 (UMLS CUI [2,1])
C0441889 (UMLS CUI [2,2])
C0887812 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Interferon
Item
patients with a history of hypersensitivity to test drugs or other interferon preparations
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C3652465 (UMLS CUI [2,2])
Hypersensitivity Biological Products | Vaccines allergy
Item
patients with a history of hypersensitivity to biological products, such as vaccines
boolean
C0020517 (UMLS CUI [1,1])
C0005522 (UMLS CUI [1,2])
C0571550 (UMLS CUI [2])
shosaiko-to
Item
patients being treated with shosaikoto
boolean
C1138004 (UMLS CUI [1])
Hepatitis, Autoimmune
Item
patients with autoimmune hepatitis
boolean
C0241910 (UMLS CUI [1])
Pregnancy | Possible pregnancy | Breast Feeding
Item
pregnant women, women who may be pregnant, and nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Hypersensitivity Investigational New Drug Component | Hypersensitivity Nucleoside Analogs | Aciclovir allergy | Ganciclovir allergy | Vidarabine allergy
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])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1579410 (UMLS CUI [2,2])
C0571297 (UMLS CUI [3])
C0571283 (UMLS CUI [4])
C0571296 (UMLS CUI [5])
Heart Diseases CONTROL DIFFICULT | Myocardial Infarction | Heart failure | Cardiac Arrhythmia
Item
patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)
boolean
C0018799 (UMLS CUI [1,1])
C0742800 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
Hemoglobinopathies | Thalassemia | Anemia, Sickle Cell
Item
patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)
boolean
C0019045 (UMLS CUI [1])
C0039730 (UMLS CUI [2])
C0002895 (UMLS CUI [3])
Kidney Failure, Chronic | Renal function disorder | Creatinine clearance measurement
Item
patients with chronic renal failure or renal function disorder with creatinine clearance of <=50 ml/min
boolean
C0022661 (UMLS CUI [1])
C0859242 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Mental Disorders, Severe | Severe depression | Feeling suicidal | Suicide attempt
Item
patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt
boolean
C4046029 (UMLS CUI [1])
C0588008 (UMLS CUI [2])
C0424000 (UMLS CUI [3])
C0038663 (UMLS CUI [4])
Liver Dysfunction Serious
Item
patients with serious hepatic dysfunction
boolean
C0086565 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Hepatitis, Autoimmune
Item
patients with autoimmune hepatitis
boolean
C0241910 (UMLS CUI [1])
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