ID

33819

Description

Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study); ODM derived from: https://clinicaltrials.gov/show/NCT02175966

Link

https://clinicaltrials.gov/show/NCT02175966

Keywords

Versions (1)
  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 NCT02175966

English

Eligibility Hepatitis C NCT02175966

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females ≥18 years of age, inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
chronic hcv infection genotype 1 only
Description

Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0017431
non-cirrhotic
Description

Liver Cirrhosis Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
treatment naive subjects with no previous exposure to an interferon formulation (ie, ifnα, pegifnα), ribavirin (rbv) or hcv direct acting antiviral (daa) (protease, polymerase inhibitor, etc.)
Description

Therapy naive | Absence Exposure to Interferon | Absence Exposure to Interferon-alpha | Absence Exposure to Peginterferon alfa-2a | Absence Exposure to Peginterferon alfa-2b | Absence Exposure to Ribavirin | Absence Exposure to Direct Acting Anti-hepatitis C (HCV) Agents | Absence Exposure to Proteases | Absence Exposure to Polymerase Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C3652465
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0332157
UMLS CUI [3,3]
C0002199
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0332157
UMLS CUI [4,3]
C0391001
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0332157
UMLS CUI [5,3]
C0796545
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C0332157
UMLS CUI [6,3]
C0035525
UMLS CUI [7,1]
C0332197
UMLS CUI [7,2]
C0332157
UMLS CUI [7,3]
C4324239
UMLS CUI [8,1]
C0332197
UMLS CUI [8,2]
C0332157
UMLS CUI [8,3]
C0030940
UMLS CUI [9,1]
C0332197
UMLS CUI [9,2]
C0332157
UMLS CUI [9,3]
C1335439
UMLS CUI [9,4]
C1999216
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hcv genotype other than genotype 1
Description

Hepatitis C virus genotype Except Genotype 1

Data type

boolean

Alias
UMLS CUI [1,1]
C1148363
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C3532919
documented or suspected hepatocellular carcinoma
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
evidence of decompensated liver disease
Description

Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C4075847
contraindication(s) to peg/rbv therapy
Description

Medical contraindication Peginterferon | Medical contraindication Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0982327
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0035525
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Similar models

Eligibility Hepatitis C NCT02175966

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females ≥18 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C Genotype
Item
chronic hcv infection genotype 1 only
boolean
C0524910 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
Liver Cirrhosis Absent
Item
non-cirrhotic
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Therapy naive | Absence Exposure to Interferon | Absence Exposure to Interferon-alpha | Absence Exposure to Peginterferon alfa-2a | Absence Exposure to Peginterferon alfa-2b | Absence Exposure to Ribavirin | Absence Exposure to Direct Acting Anti-hepatitis C (HCV) Agents | Absence Exposure to Proteases | Absence Exposure to Polymerase Inhibitor
Item
treatment naive subjects with no previous exposure to an interferon formulation (ie, ifnα, pegifnα), ribavirin (rbv) or hcv direct acting antiviral (daa) (protease, polymerase inhibitor, etc.)
boolean
C0919936 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C3652465 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
C0002199 (UMLS CUI [3,3])
C0332197 (UMLS CUI [4,1])
C0332157 (UMLS CUI [4,2])
C0391001 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C0332157 (UMLS CUI [5,2])
C0796545 (UMLS CUI [5,3])
C0332197 (UMLS CUI [6,1])
C0332157 (UMLS CUI [6,2])
C0035525 (UMLS CUI [6,3])
C0332197 (UMLS CUI [7,1])
C0332157 (UMLS CUI [7,2])
C4324239 (UMLS CUI [7,3])
C0332197 (UMLS CUI [8,1])
C0332157 (UMLS CUI [8,2])
C0030940 (UMLS CUI [8,3])
C0332197 (UMLS CUI [9,1])
C0332157 (UMLS CUI [9,2])
C1335439 (UMLS CUI [9,3])
C1999216 (UMLS CUI [9,4])
Item Group
C0680251 (UMLS CUI)
Hepatitis C virus genotype Except Genotype 1
Item
hcv genotype other than genotype 1
boolean
C1148363 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C3532919 (UMLS CUI [1,3])
Liver carcinoma Documented | Liver carcinoma Suspected
Item
documented or suspected hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1,1])
C1301725 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Decompensated liver disease
Item
evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Medical contraindication Peginterferon | Medical contraindication Ribavirin
Item
contraindication(s) to peg/rbv therapy
boolean
C1301624 (UMLS CUI [1,1])
C0982327 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
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