ID

14217

Description

Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous Hepatitis C Virus (HCV) Non Responders; ODM derived from: https://clinicaltrials.gov/show/NCT00122629

Lien

https://clinicaltrials.gov/show/NCT00122629

Mots-clés

  1. 04/04/2016 04/04/2016 -
Téléchargé le

4 avril 2016

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.

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 NCT00122629

Eligibility Hepatitis C, Chronic NCT00122629

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
positive anti-hcv antibody test
Description

Anti-hcv antibody test

Type de données

boolean

Alias
UMLS CUI [1]
C0201487
patients who did not respond to treatment with standard interferon + ribavirin (hcv rna+ by pcr in the last month of treatment)
Description

Response to standard HCV treatment (by HCV RNA)

Type de données

boolean

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0717864
UMLS CUI [2]
C0369335
compensated liver disease
Description

Liver function

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
neutrophil count over or equal to1000/mm3
Description

Neutrophil count

Type de données

boolean

Alias
UMLS CUI [1]
C0200633
platelet count over or equal to 100 giga/l
Description

Platelet count

Type de données

boolean

Alias
UMLS CUI [1]
C0032181
haemoglobin over or equal to 10g/dl
Description

Haemoglobin

Type de données

boolean

Alias
UMLS CUI [1]
C0518015
patients had to have undergone a post-treatment liver biopsy within a year, showing a metavir histological score over or equal to a1f1, without cirrhosis (fibrosis score below f4)
Description

Post-treatment liver biopsy (metavir histological score + fibrosis score)

Type de données

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C2709088
UMLS CUI [2]
C3888527
UMLS CUI [3]
C1954437
alt over n and hcv rna+ at screening
Description

ALT measurement and HCV RNA

Type de données

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0369335
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection with hepatitis b or human immunodeficiency virus
Description

Co-infections

Type de données

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0019682
any other cause of liver disease
Description

Liver disease etiology

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C1314792
active drug abuse, active alcohol consumption above 40g/day
Description

Substance use disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
organ grafts
Description

Organ graft

Type de données

boolean

Alias
UMLS CUI [1]
C0524930
presence of hepatocellular carcinoma
Description

Hepatocellular carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C2239176
cardiovascular, metabolic, renal, haematological, neurological or psychiatric disease
Description

Comorbidity

Type de données

boolean

Alias
UMLS CUI [1]
C0009488
patients with previous amantadine use
Description

Amantadine

Type de données

boolean

Alias
UMLS CUI [1]
C0002403
systemic immunosuppressive or antiviral treatment during the last 24 weeks and those with a history of interferon and/or ribavirin intolerance
Description

Immunossuppressive or antiviral treatment and drug intolerance

Type de données

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C2363964
UMLS CUI [3]
C0277585

Similar models

Eligibility Hepatitis C, Chronic NCT00122629

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Anti-hcv antibody test
Item
positive anti-hcv antibody test
boolean
C0201487 (UMLS CUI [1])
Response to standard HCV treatment (by HCV RNA)
Item
patients who did not respond to treatment with standard interferon + ribavirin (hcv rna+ by pcr in the last month of treatment)
boolean
C0521982 (UMLS CUI [1,1])
C0717864 (UMLS CUI [1,2])
C0369335 (UMLS CUI [2])
Liver function
Item
compensated liver disease
boolean
C0232741 (UMLS CUI [1])
Neutrophil count
Item
neutrophil count over or equal to1000/mm3
boolean
C0200633 (UMLS CUI [1])
Platelet count
Item
platelet count over or equal to 100 giga/l
boolean
C0032181 (UMLS CUI [1])
Haemoglobin
Item
haemoglobin over or equal to 10g/dl
boolean
C0518015 (UMLS CUI [1])
Post-treatment liver biopsy (metavir histological score + fibrosis score)
Item
patients had to have undergone a post-treatment liver biopsy within a year, showing a metavir histological score over or equal to a1f1, without cirrhosis (fibrosis score below f4)
boolean
C0193388 (UMLS CUI [1,1])
C2709088 (UMLS CUI [1,2])
C3888527 (UMLS CUI [2])
C1954437 (UMLS CUI [3])
ALT measurement and HCV RNA
Item
alt over n and hcv rna+ at screening
boolean
C0201836 (UMLS CUI [1])
C0369335 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Co-infections
Item
co-infection with hepatitis b or human immunodeficiency virus
boolean
C2242656 (UMLS CUI [1])
C0275524 (UMLS CUI [2,1])
C0019682 (UMLS CUI [2,2])
Liver disease etiology
Item
any other cause of liver disease
boolean
C0023895 (UMLS CUI [1,1])
C1314792 (UMLS CUI [1,2])
Substance use disorder
Item
active drug abuse, active alcohol consumption above 40g/day
boolean
C0038586 (UMLS CUI [1])
Organ graft
Item
organ grafts
boolean
C0524930 (UMLS CUI [1])
Hepatocellular carcinoma
Item
presence of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Comorbidity
Item
cardiovascular, metabolic, renal, haematological, neurological or psychiatric disease
boolean
C0009488 (UMLS CUI [1])
Amantadine
Item
patients with previous amantadine use
boolean
C0002403 (UMLS CUI [1])
Immunossuppressive or antiviral treatment and drug intolerance
Item
systemic immunosuppressive or antiviral treatment during the last 24 weeks and those with a history of interferon and/or ribavirin intolerance
boolean
C0021079 (UMLS CUI [1])
C2363964 (UMLS CUI [2])
C0277585 (UMLS CUI [3])

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

Les champs marqués d’un * sont obligatoires.

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