ID

39642

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01492504

Keywords

versioni (1)
  1. 07/02/20 07/02/20 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

7 febbraio 2020

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Hepatitis C NCT01492504

Inglese

Eligibility Hepatitis C NCT01492504

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed written informed consent
Descrizione

Informed Consent

Tipo di dati

boolean

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

Asunaprevir Dose Quantity | Daclatasvir Dose Quantity

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Clinical Trial Previous | Follow-up Completed

Tipo di dati

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
Descrizione

Study Subject Participation Status | Clinical Trial Previous Completed

Tipo di dati

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
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descrizione

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
Descrizione

Antiviral Therapy Chronic Hepatitis C | Immunomodulatory therapy Chronic Hepatitis C

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Prisoners | Study Subject incarcerated

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Ritorna all'inizio della pagina

Similar models

Eligibility Hepatitis C NCT01492504

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

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