Informatie:
Fout:
ID
35885
Beschrijving
Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02487199
Link
https://clinicaltrials.gov/show/NCT02487199
Trefwoorden
Versies (1)
- 01-04-19 01-04-19 -
Houder van rechten
See clinicaltrials.gov
Geüploaded op
1 april 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Eligibility HCV NCT02487199
Eligibility HCV NCT02487199
- StudyEvent: Eligibility
Similar models
Eligibility HCV NCT02487199
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Hepatitis C, Chronic | Hepatitis C virus genotype Infection | Hepatitis C virus RNA assay
Item
chronic hepatitis c, genotype 1a infection or genotype 4 infection (hcv rna level greater than 1,000 iu/ml at screening).
boolean
C0524910 (UMLS CUI [1])
C1148363 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
C1272251 (UMLS CUI [3])
C1148363 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
C1272251 (UMLS CUI [3])
Postmenopausal state | Childbearing Potential Absent | Childbearing Potential Contraceptive methods
Item
females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control.
boolean
C0232970 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Chronic Kidney Disease Stage
Item
chronic kidney disease stage 4 or stage 5.
boolean
C1561643 (UMLS CUI [1,1])
C2074731 (UMLS CUI [1,2])
C2074731 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
females who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Hepatitis B surface antigen positive | HIV antibody positive
Item
positive screen for hepatitis b surface antigen or anti-human immunodeficiency virus antibody
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])
C0920548 (UMLS CUI [2])
Hepatitis C virus genotype determination | Genotype Mixed Absent
Item
hcv genotype performed during screening unable to genotype or co-infection with any other hcv genotype, no mixed genotypes.
boolean
C1533728 (UMLS CUI [1])
C0017431 (UMLS CUI [2,1])
C0205430 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0017431 (UMLS CUI [2,1])
C0205430 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Laboratory test result abnormal
Item
abnormal laboratory tests
boolean
C0438215 (UMLS CUI [1])
Study Subject Participation Status
Item
current enrollment in another investigational study
boolean
C2348568 (UMLS CUI [1])
DIRECT ACTING ANTIVIRALS
Item
previous or current treatment with a direct acting antiviral agent (daa) containing regimen
boolean
C3653501 (UMLS CUI [1])
Liver Cirrhosis | Liver carcinoma
Item
any evidence of liver cirrhosis or liver cancer
boolean
C0023890 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
C2239176 (UMLS CUI [2])