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

Lien

https://clinicaltrials.gov/show/NCT00724230

Mots-clés

Versions (1)
  1. 12/04/2017 12/04/2017 -
Téléchargé le

12 avril 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Hepatitis C, Chronic NCT00724230

Anglais

Eligibility Hepatitis C, Chronic NCT00724230

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with chronic hepatitis c
Description

Chronic Hepatitis C

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Hypersensitivity to biological products

Type de données

boolean

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

Shosaikoto

Type de données

boolean

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

Autoimmune hepatitis

Type de données

boolean

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

Gynaecological status

Type de données

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

Type de données

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

Type de données

boolean

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

Hemoglobinopathies

Type de données

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

Type de données

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

Type de données

boolean

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

Liver function

Type de données

boolean

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

Autoimmune hepatitis

Type de données

boolean

Alias
UMLS CUI [1]
C0241910
Retour au début de la page

Similar models

Eligibility Hepatitis C, Chronic NCT00724230

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial