Information:
Fel:
ID
39649
Beskrivning
An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus; ODM derived from: https://clinicaltrials.gov/show/NCT01701063
Länk
https://clinicaltrials.gov/show/NCT01701063
Nyckelord
Versioner (1)
- 2020-02-08 2020-02-08 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
8 februari 2020
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01701063
Eligibility Hepatitis C NCT01701063
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C NCT01701063
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Age
Item
males or females ages 3 to 17 years of age
boolean
C0001779 (UMLS CUI [1])
Hepatitis C, Chronic
Item
chronic hepatitis c
boolean
C0524910 (UMLS CUI [1])
Hepatitis C virus genotype determination
Item
hepatitis c virus genotype 1a or b at the screening visit
boolean
C1533728 (UMLS CUI [1])
Good health | Exception Hepatitis C
Item
subject is judged to be in good health (besides hcv infection) in the opinion of the investigator.
boolean
C3813622 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Informed Consent
Item
signed icf, and where appropriate, signed assent form
boolean
C0021430 (UMLS CUI [1])
Medical condition Associated with Chronic liver disease | Exception Hepatitis C
Item
history of or prior evidence of a medical condition associated with chronic liver disease other than hcv
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Body Weight
Item
body weight <15 kg or >90 kg
boolean
C0005910 (UMLS CUI [1])
Hepatic decompensation
Item
prior evidence of hepatic decompensation
boolean
C1394798 (UMLS CUI [1])
Medical contraindication PEGINTERFERON/RIBAVIRIN
Item
contraindications to peg-ifn/rbv
boolean
C1301624 (UMLS CUI [1,1])
C1875630 (UMLS CUI [1,2])
C1875630 (UMLS CUI [1,2])
Retinal Disease Severe | Disorder of eye
Item
history or other evidence of severe retinopathy or clinically significant ophthalmological disorder
boolean
C0035309 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0015397 (UMLS CUI [2])
C0205082 (UMLS CUI [1,2])
C0015397 (UMLS CUI [2])
Hepatitis C Except Genotype determination
Item
history of non-genotype 1 hcv
boolean
C0019196 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C1533728 (UMLS CUI [1,3])
C0332300 (UMLS CUI [1,2])
C1533728 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
participation in investigational drug study as described in study protocol
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0013230 (UMLS CUI [2])
Illicit medication use
Item
use of prohibited drugs within 7 days or 5 half-lives before the first dose of study drug
boolean
C0281875 (UMLS CUI [1])