Informações:
Falhas:
ID
16276
Descrição
Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment Naive Adults With Chronic Hepatitis B Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00034359
Link
https://clinicaltrials.gov/show/NCT00034359
Palavras-chave
Versões (1)
- 08/07/2016 08/07/2016 -
Transferido a
8 de julho de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT00034359
Eligibility Hepatitis B, Chronic NCT00034359
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B, Chronic NCT00034359
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
age
Item
adults >= 18 years of age
boolean
C0001779 (UMLS CUI [1])
chronic hbv infection, hbsag positive
Item
chronic hbv infection, known to be hbsag positive >= 6 months
boolean
C0149709 (UMLS CUI [1])
plasma hbv dna level
Item
plasma hbv dna level >= 100,000 copies/ml
boolean
C3641250 (UMLS CUI [1])
hbe-antigen positive
Item
hbe-antigen positive
boolean
C0392390 (UMLS CUI [1])
hiv negative
Item
hiv negative
boolean
C0481430 (UMLS CUI [1])
normal blood test
Item
basic hematologic and chemistry parameters within acceptable limits (defined in protocol
boolean
C0919709 (UMLS CUI [1])
medication
Item
no need for excluded medications
boolean
C0013227 (UMLS CUI [1])
contraceptive methods
Item
subjects of reproductive capability must utilize two approved forms of birth control, one of which must be barrier protection.
boolean
C0700589 (UMLS CUI [1])
hiv infection
Item
hiv infection
boolean
C0019693 (UMLS CUI [1])
hepatitis c co-infection
Item
hepatitis c co-infection
boolean
C1112419 (UMLS CUI [1])
concurrent systemic antiviral treatment
Item
concurrent systemic antiviral treatment
boolean
C0009429 (UMLS CUI [1,1])
C2363964 (UMLS CUI [1,2])
C2363964 (UMLS CUI [1,2])
prior antiviral treatment or treatment with 3tc
Item
previous antiviral treatment for hbv infection within 6 months prior to randomization or treatment with 3tc for more than 6 months at any time in the past
boolean
C1514463 (UMLS CUI [1,1])
C2363964 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0209738 (UMLS CUI [2,2])
C2363964 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0209738 (UMLS CUI [2,2])
prior myelosuppressive or cytotoxic therapy
Item
previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start
boolean
C1514463 (UMLS CUI [1,1])
C1513793 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0677881 (UMLS CUI [2,2])
C1513793 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0677881 (UMLS CUI [2,2])
alcohol abuse
Item
alcohol abuse
boolean
C0038586 (UMLS CUI [1])
pregnancy or breast-feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
inability to tolerate oral medication
Item
inability to tolerate oral medication
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0001563 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,2])
C0001563 (UMLS CUI [1,3])
ast
Item
ast>7.0 times the upper limit of normal
boolean
C0201899 (UMLS CUI [1])
alt
Item
alt>7.0 times the upper limit of normal
boolean
exclusion criteria
Item
any clinical condition or prior therapy that, in the investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements
boolean
C0680251 (UMLS CUI [1])
use of any investigational drug
Item
use of any investigational drug.
boolean
C0013230 (UMLS CUI [1])