ID

39680

Description

Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir; ODM derived from: https://clinicaltrials.gov/show/NCT01598090

Link

https://clinicaltrials.gov/show/NCT01598090

Keywords

Versions (1)
  1. 2/9/20 2/9/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 9, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C Virus NCT01598090

English

Eligibility Hepatitis C Virus NCT01598090

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis c genotype 1. gt-1b capped at 50 % of naïve subjects
Description

Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
naives to prior anti-hcv therapy [interferon (ifn) and direct antiviral agent (daa) based]
Description

Anti-hepatitis C (HCV) Agents Absent | Interferon Absent | DIRECT ACTING ANTIVIRALS Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C4324240
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3653501
UMLS CUI [3,2]
C0332197
relapsers (defined as subjects who had undetectable hcv ribonucleic acid (rna) on prior treatment regimen of alfa-2a/rbv and hepatitis c virus (hcv) rna > 25iu/ml after discontinuation of treatment). capped at 20%
Description

Recurrent disease | Hepatitis C virus RNA Undetectable | Status post Interferon Alfa-2a Ribavirin | Hepatitis C virus RNA assay | Status post Therapeutic procedure Discontinued

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0369335
UMLS CUI [2,2]
C3827727
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0021734
UMLS CUI [3,3]
C0035525
UMLS CUI [4]
C1272251
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0087111
UMLS CUI [5,3]
C1444662
hcv rna ≥ 100,000 iu/ml
Description

Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1]
C1272251
subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%
Description

Compensated cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C1608426
seronegative for human immunodeficiency virus (hiv) and hepatitis b surface antigen (hbsag)
Description

HIV Seronegative | Hepatitis B Surface Antigens Seronegative

Data type

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0521144
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0521144
men or women, 18-70 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
chronic liver disease due to causes other than chronic hcv
Description

Chronic liver disease | Etiology Except Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0524910
current or past evidence of decompensation
Description

Decompensation

Data type

boolean

Alias
UMLS CUI [1]
C0231187
conditions that preclude the use of alfa/rbv/tvr per respective labels
Description

Condition Excludes Interferon-alpha | Condition Excludes Ribavirin | Condition Excludes Telaprevir

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0002199
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0035525
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C1876229
diagnosed or suspected hepatocellular carcinoma
Description

Liver carcinoma | Liver carcinoma Suspected

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0750491
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Similar models

Eligibility Hepatitis C Virus NCT01598090

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
chronic hepatitis c genotype 1. gt-1b capped at 50 % of naïve subjects
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Anti-hepatitis C (HCV) Agents Absent | Interferon Absent | DIRECT ACTING ANTIVIRALS Absent
Item
naives to prior anti-hcv therapy [interferon (ifn) and direct antiviral agent (daa) based]
boolean
C4324240 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3653501 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Recurrent disease | Hepatitis C virus RNA Undetectable | Status post Interferon Alfa-2a Ribavirin | Hepatitis C virus RNA assay | Status post Therapeutic procedure Discontinued
Item
relapsers (defined as subjects who had undetectable hcv ribonucleic acid (rna) on prior treatment regimen of alfa-2a/rbv and hepatitis c virus (hcv) rna > 25iu/ml after discontinuation of treatment). capped at 20%
boolean
C0277556 (UMLS CUI [1])
C0369335 (UMLS CUI [2,1])
C3827727 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0021734 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
C1272251 (UMLS CUI [4])
C0231290 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C1444662 (UMLS CUI [5,3])
Hepatitis C virus RNA assay
Item
hcv rna ≥ 100,000 iu/ml
boolean
C1272251 (UMLS CUI [1])
Compensated cirrhosis
Item
subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%
boolean
C1608426 (UMLS CUI [1])
HIV Seronegative | Hepatitis B Surface Antigens Seronegative
Item
seronegative for human immunodeficiency virus (hiv) and hepatitis b surface antigen (hbsag)
boolean
C0019682 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
C0019168 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
Age
Item
men or women, 18-70 years of age
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic liver disease | Etiology Except Chronic Hepatitis C
Item
chronic liver disease due to causes other than chronic hcv
boolean
C0341439 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
Decompensation
Item
current or past evidence of decompensation
boolean
C0231187 (UMLS CUI [1])
Condition Excludes Interferon-alpha | Condition Excludes Ribavirin | Condition Excludes Telaprevir
Item
conditions that preclude the use of alfa/rbv/tvr per respective labels
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0002199 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C1876229 (UMLS CUI [3,3])
Liver carcinoma | Liver carcinoma Suspected
Item
diagnosed or suspected hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
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