ID

39642

Description

Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01492504

Lien

https://clinicaltrials.gov/show/NCT01492504

Mots-clés

Versions (1)
  1. 07/02/2020 07/02/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

7 février 2020

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 NCT01492504

Anglais

Eligibility Hepatitis C NCT01492504

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed written informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
subjects must have received at least one dose of asunaprevir and/or daclatasvir
Description

Asunaprevir Dose Quantity | Daclatasvir Dose Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C3491974
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C3252090
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1265611
subjects participating in daclatasvir and/or asunaprevir studies (ie, protocol numbers beginning with ai443, ai444 or ai447) may enroll regardless of virologic response
Description

Study Subject Participation Status Clinical Trial Daclatasvir | Study Subject Participation Status Clinical Trial Asunaprevir | Enrollment Independent of Virologic Response

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C3252090
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C3491974
UMLS CUI [3,1]
C1516879
UMLS CUI [3,2]
C0332291
UMLS CUI [3,3]
C4053862
completed the required post-treatment follow-up period in previous study
Description

Clinical Trial Previous | Follow-up Completed

Type de données

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0205197
must enroll in this study within 6 months of completing previous bms study or within 6 months of protocol availability at the clinical site
Description

Study Subject Participation Status | Clinical Trial Previous Completed

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0205197
men and women, ages 18 and older
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis c (chc) after completion of the previous study during which asunaprevir and/or daclatasvir were administered
Description

Antiviral Therapy Chronic Hepatitis C | Immunomodulatory therapy Chronic Hepatitis C

Type de données

boolean

Alias
UMLS CUI [1,1]
C0280274
UMLS CUI [1,2]
C0524910
UMLS CUI [2,1]
C1963758
UMLS CUI [2,2]
C0524910
subject must not be participating in any other trial, excluding non-interventional trials
Description

Study Subject Participation Status | Clinical Trial | Exception Interventional procedure Absent

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0184661
UMLS CUI [3,3]
C0332197
prisoners or subjects who are involuntarily incarcerated
Description

Prisoners | Study Subject incarcerated

Type de données

boolean

Alias
UMLS CUI [1]
C0033167
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0392751
subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Description

Study Subject Incarcerated | Psychiatric therapeutic procedure | Treatment Physical illness | Treatment Communicable Disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0392751
UMLS CUI [2]
C0204523
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0683323
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0009450
Retour au début de la page

Similar models

Eligibility Hepatitis C NCT01492504

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Asunaprevir Dose Quantity | Daclatasvir Dose Quantity
Item
subjects must have received at least one dose of asunaprevir and/or daclatasvir
boolean
C3491974 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3252090 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Study Subject Participation Status Clinical Trial Daclatasvir | Study Subject Participation Status Clinical Trial Asunaprevir | Enrollment Independent of Virologic Response
Item
subjects participating in daclatasvir and/or asunaprevir studies (ie, protocol numbers beginning with ai443, ai444 or ai447) may enroll regardless of virologic response
boolean
C2348568 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C3252090 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C3491974 (UMLS CUI [2,3])
C1516879 (UMLS CUI [3,1])
C0332291 (UMLS CUI [3,2])
C4053862 (UMLS CUI [3,3])
Clinical Trial Previous | Follow-up Completed
Item
completed the required post-treatment follow-up period in previous study
boolean
C0008976 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Study Subject Participation Status | Clinical Trial Previous Completed
Item
must enroll in this study within 6 months of completing previous bms study or within 6 months of protocol availability at the clinical site
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Age
Item
men and women, ages 18 and older
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antiviral Therapy Chronic Hepatitis C | Immunomodulatory therapy Chronic Hepatitis C
Item
subject must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis c (chc) after completion of the previous study during which asunaprevir and/or daclatasvir were administered
boolean
C0280274 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
C1963758 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Study Subject Participation Status | Clinical Trial | Exception Interventional procedure Absent
Item
subject must not be participating in any other trial, excluding non-interventional trials
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Prisoners | Study Subject incarcerated
Item
prisoners or subjects who are involuntarily incarcerated
boolean
C0033167 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C0392751 (UMLS CUI [2,2])
Study Subject Incarcerated | Psychiatric therapeutic procedure | Treatment Physical illness | Treatment Communicable Disease
Item
subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
boolean
C0681850 (UMLS CUI [1,1])
C0392751 (UMLS CUI [1,2])
C0204523 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0683323 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0009450 (UMLS CUI [4,2])
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