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

Link

https://clinicaltrials.gov/show/NCT01492504

Keywords

Versions (1)
  1. 2/7/20 2/7/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 7, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01492504

English

Eligibility Hepatitis C NCT01492504

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed written informed consent
Description

Informed Consent

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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
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Similar models

Eligibility Hepatitis C NCT01492504

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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