ID

24283

Description

Efficacy of PegIntron (Peginterferon Alfa-2b) and Rebetol (Ribavirin) in Treatment-naïve Subjects With Chronic Hepatitis C in Clinical Practice in Greece (Study P05209); ODM derived from: https://clinicaltrials.gov/show/NCT00724464

Lien

https://clinicaltrials.gov/show/NCT00724464

Mots-clés

Versions (1)
  1. 28/07/2017 28/07/2017 -
Téléchargé le

28 juillet 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 NCT00724464

Anglais

Eligibility Hepatitis C, Chronic NCT00724464

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants who have already begun summary of product characteristics (smpc)-based combination treatment with pegylated interferon alpha-2b and ribavirin, prior to the site initiation date.
Description

Combined Modality Therapy Started | peginterferon alfa-2b | Ribavirin

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C1272689
UMLS CUI [2]
C0796545
UMLS CUI [3]
C0035525
participants who have been receiving combination treatment with pegylated interferon alpha-2b and ribavirin for at least 6 months before enrollment.
Description

Combined Modality Therapy Previous | peginterferon alfa-2b | Ribavirin

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0796545
UMLS CUI [3]
C0035525
participants who have achieved negative hcv rna at the end of treatment, defined according to genotype (24 weeks for hcv genotypes 2/3 and 48 weeks for genotypes 1/4).
Description

HCV RNA Negative | Hepatitis C virus genotype

Type de données

boolean

Alias
UMLS CUI [1,1]
C1868902
UMLS CUI [1,2]
C1513916
UMLS CUI [2]
C1148363
participants with diagnosed chronic hepatitis c (chc) and hcv genotype 1, 2, 3 or 4.
Description

Hepatitis C, Chronic | Hepatitis C virus genotype

Type de données

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2]
C1148363
participants older than 18 years, regardless of gender or race.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the participant has received treatment for chc in the past (not treatment-naive).
Description

Therapeutic procedure Chronic Hepatitis C

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0524910
the participant has received treatment in the context of a clinical trial in the participating site.
Description

Therapeutic procedure | Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C2348568
the participant has been diagnosed with a concomitant infection e.g. with hepatitis b or hiv
Description

Communicable Diseases | Hepatitis B | HIV Infection

Type de données

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019693
the participant has de-compensated liver disease or belongs to a special population, such as liver transplant, hemophilia, severe pre-existing psychiatric disorder, auto-immune disease, thalassaemia.
Description

Decompensated liver disease | Transplantation of liver | Hemophilia | Mental disorders Pre-existing Severe | Autoimmune Diseases | Thalassemia

Type de données

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0023911
UMLS CUI [3]
C0684275
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C2347662
UMLS CUI [4,3]
C0205082
UMLS CUI [5]
C0004364
UMLS CUI [6]
C0039730
the participant has positive hcv rna at the end of treatment.
Description

HCV RNA Positive

Type de données

boolean

Alias
UMLS CUI [1,1]
C1868902
UMLS CUI [1,2]
C1514241
pregnant women or women intending to bear children or sexual partners of women wishing to bear children and for a 7-month period after the end of treatment, as indicated in the smpc of rebetol.
Description

Pregnancy | Pregnancy, Planned | Partner in relationship Planned Pregnancy | Rebetol

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3,1]
C0682323
UMLS CUI [3,2]
C0032992
UMLS CUI [4]
C1170576
the participant is not eligible on grounds of contra-indications, special warnings, particular population and/or the section on pregnancy and lactation of the smpc.
Description

Medical contraindication | Cautionary Warning | Population Specific | Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C1301624
UMLS CUI [2]
C0871599
UMLS CUI [3,1]
C1257890
UMLS CUI [3,2]
C0205369
UMLS CUI [4]
C0032961
UMLS CUI [5]
C0006147
the participant has interrupted treatment for any reason.
Description

Therapy interrupted

Type de données

boolean

Alias
UMLS CUI [1]
C1710384
Retour au début de la page

Similar models

Eligibility Hepatitis C, Chronic NCT00724464

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Combined Modality Therapy Started | peginterferon alfa-2b | Ribavirin
Item
participants who have already begun summary of product characteristics (smpc)-based combination treatment with pegylated interferon alpha-2b and ribavirin, prior to the site initiation date.
boolean
C0009429 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
C0796545 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
Combined Modality Therapy Previous | peginterferon alfa-2b | Ribavirin
Item
participants who have been receiving combination treatment with pegylated interferon alpha-2b and ribavirin for at least 6 months before enrollment.
boolean
C0009429 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0796545 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
HCV RNA Negative | Hepatitis C virus genotype
Item
participants who have achieved negative hcv rna at the end of treatment, defined according to genotype (24 weeks for hcv genotypes 2/3 and 48 weeks for genotypes 1/4).
boolean
C1868902 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C1148363 (UMLS CUI [2])
Hepatitis C, Chronic | Hepatitis C virus genotype
Item
participants with diagnosed chronic hepatitis c (chc) and hcv genotype 1, 2, 3 or 4.
boolean
C0524910 (UMLS CUI [1])
C1148363 (UMLS CUI [2])
Age
Item
participants older than 18 years, regardless of gender or race.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Chronic Hepatitis C
Item
the participant has received treatment for chc in the past (not treatment-naive).
boolean
C0087111 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
Therapeutic procedure | Study Subject Participation Status
Item
the participant has received treatment in the context of a clinical trial in the participating site.
boolean
C0087111 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Communicable Diseases | Hepatitis B | HIV Infection
Item
the participant has been diagnosed with a concomitant infection e.g. with hepatitis b or hiv
boolean
C0009450 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Decompensated liver disease | Transplantation of liver | Hemophilia | Mental disorders Pre-existing Severe | Autoimmune Diseases | Thalassemia
Item
the participant has de-compensated liver disease or belongs to a special population, such as liver transplant, hemophilia, severe pre-existing psychiatric disorder, auto-immune disease, thalassaemia.
boolean
C4075847 (UMLS CUI [1])
C0023911 (UMLS CUI [2])
C0684275 (UMLS CUI [3])
C0004936 (UMLS CUI [4,1])
C2347662 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C0004364 (UMLS CUI [5])
C0039730 (UMLS CUI [6])
HCV RNA Positive
Item
the participant has positive hcv rna at the end of treatment.
boolean
C1868902 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Pregnancy | Pregnancy, Planned | Partner in relationship Planned Pregnancy | Rebetol
Item
pregnant women or women intending to bear children or sexual partners of women wishing to bear children and for a 7-month period after the end of treatment, as indicated in the smpc of rebetol.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0682323 (UMLS CUI [3,1])
C0032992 (UMLS CUI [3,2])
C1170576 (UMLS CUI [4])
Medical contraindication | Cautionary Warning | Population Specific | Pregnancy | Breast Feeding
Item
the participant is not eligible on grounds of contra-indications, special warnings, particular population and/or the section on pregnancy and lactation of the smpc.
boolean
C1301624 (UMLS CUI [1])
C0871599 (UMLS CUI [2])
C1257890 (UMLS CUI [3,1])
C0205369 (UMLS CUI [3,2])
C0032961 (UMLS CUI [4])
C0006147 (UMLS CUI [5])
Therapy interrupted
Item
the participant has interrupted treatment for any reason.
boolean
C1710384 (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