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ID
33817
Beschrijving
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
Trefwoorden
Versies (1)
- 28-12-18 28-12-18 -
Houder van rechten
See clinicaltrials.gov
Geüploaded op
28 december 2018
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01389323
Eligibility Hepatitis C NCT01389323
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C NCT01389323
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
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])
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])
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])
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])
C0439686 (UMLS CUI [2,1])
C0205432 (UMLS CUI [2,2])
C0332287 (UMLS CUI [2,3])
C0220847 (UMLS CUI [2,4])
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])
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])
C0369497 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C3469372 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])