Information:
Fel:
ID
39680
Beskrivning
Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir; ODM derived from: https://clinicaltrials.gov/show/NCT01598090
Länk
https://clinicaltrials.gov/show/NCT01598090
Nyckelord
Versioner (1)
- 2020-02-09 2020-02-09 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
9 februari 2020
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Hepatitis C Virus NCT01598090
Eligibility Hepatitis C Virus NCT01598090
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C Virus NCT01598090
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
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])
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])
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])
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])
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])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])