ID

33817

Description

BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01389323

Link

https://clinicaltrials.gov/show/NCT01389323

Keywords

  1. 12/28/18 12/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 28, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis C NCT01389323

Eligibility Hepatitis C NCT01389323

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects chronically infected with hcv (hepatitis c virus) genotype 1
Description

Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0017431
hcv ribonucleic acid (rna) viral load of ≥ 10,000 iu/ml at screening
Description

Hepatitis C virus RNA Viral load measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
C1261478
no previous exposure to interferon formulation, ribavirin (rbv) or hcv direct antiviral agent
Description

Absence Exposure to Interferon | Absence Exposure to Ribavirin | Absence Exposure to Direct Acting Anti-hepatitis C (HCV) Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C3652465
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0035525
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0332157
UMLS CUI [3,3]
C4324239
self-described as black-african american, latino or white-caucasian
Description

African American | Latino | Caucasian

Data type

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0086528
UMLS CUI [3]
C0043157
results of a liver biopsy obtained ≤ 36 months prior to first treatment compensated cirrhotics with hcv liver biopsy can be from any time prior to first treatment. compensated cirrhotics will be capped at approximately 25%
Description

Biopsy of liver | Cirrhotics Compensated In addition to HCV

Data type

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2,1]
C0439686
UMLS CUI [2,2]
C0205432
UMLS CUI [2,3]
C0332287
UMLS CUI [2,4]
C0220847
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of decompensated liver disease
Description

Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C4075847
documented or suspected hepatocellular carcinoma (hcc)
Description

Liver carcinoma Documented | Liver carcinoma Suspected

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1301725
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0750491
positive for hepatitis b or human immunodeficiency virus 1/human immunodeficiency virus 2 antibody at screening
Description

Hepatitis B positive | Human immunodeficiency virus type 1 antibody Positive | Serum antibody hiv-2 Positive

Data type

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2,1]
C0369497
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C3469372
UMLS CUI [3,2]
C1514241

Similar models

Eligibility Hepatitis C NCT01389323

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
subjects chronically infected with hcv (hepatitis c virus) genotype 1
boolean
C0524910 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
Hepatitis C virus RNA Viral load measurement
Item
hcv ribonucleic acid (rna) viral load of ≥ 10,000 iu/ml at screening
boolean
C0369335 (UMLS CUI [1,1])
C1261478 (UMLS CUI [1,2])
Absence Exposure to Interferon | Absence Exposure to Ribavirin | Absence Exposure to Direct Acting Anti-hepatitis C (HCV) Agents
Item
no previous exposure to interferon formulation, ribavirin (rbv) or hcv direct antiviral agent
boolean
C0332197 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C3652465 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
C4324239 (UMLS CUI [3,3])
African American | Latino | Caucasian
Item
self-described as black-african american, latino or white-caucasian
boolean
C0085756 (UMLS CUI [1])
C0086528 (UMLS CUI [2])
C0043157 (UMLS CUI [3])
Biopsy of liver | Cirrhotics Compensated In addition to HCV
Item
results of a liver biopsy obtained ≤ 36 months prior to first treatment compensated cirrhotics with hcv liver biopsy can be from any time prior to first treatment. compensated cirrhotics will be capped at approximately 25%
boolean
C0193388 (UMLS CUI [1])
C0439686 (UMLS CUI [2,1])
C0205432 (UMLS CUI [2,2])
C0332287 (UMLS CUI [2,3])
C0220847 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Decompensated liver disease
Item
evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Liver carcinoma Documented | Liver carcinoma Suspected
Item
documented or suspected hepatocellular carcinoma (hcc)
boolean
C2239176 (UMLS CUI [1,1])
C1301725 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Hepatitis B positive | Human immunodeficiency virus type 1 antibody Positive | Serum antibody hiv-2 Positive
Item
positive for hepatitis b or human immunodeficiency virus 1/human immunodeficiency virus 2 antibody at screening
boolean
C0856706 (UMLS CUI [1])
C0369497 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C3469372 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])

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