Informações:
Falhas:
ID
41435
Descrição
Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00911963
Link
https://clinicaltrials.gov/show/NCT00911963
Palavras-chave
Versões (2)
- 16/01/2019 16/01/2019 -
- 07/10/2020 07/10/2020 -
Titular dos direitos
see on clinicaltrials.gov
Transferido a
7 de outubro de 2020
DOI
Para um pedido faça login.
Licença
Creative Commons BY 4.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Eligibility Hepatitis C NCT00911963
Eligibility Hepatitis C NCT00911963
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C NCT00911963
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age, Gender, non-child bearing potential
Item
male and female subjects, 18-65 years of age (females non-child bearing potential in part b)
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0001779 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
HCV infection (anti-HCV-antibodies, HCV-RNA presence and histological evidence of chronic Hepatitis C)
Item
have laboratory evidence of hcv infection for 6 months, defined by (1) presence of anti-hcv antibody (genotype 1a and 1b infection), or (2)documented hcv rna presence by a sensitive and specific assay and (3 histologic evidence of chc (fibrosis on a standardized histological grading system)
boolean
C0019196 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C0017431 (UMLS CUI [2,2])
C0369335 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
C0449575 (UMLS CUI [4,1])
C0524910 (UMLS CUI [4,2])
C0239946 (UMLS CUI [4,3])
C0919553 (UMLS CUI [4,4])
C0166049 (UMLS CUI [2,1])
C0017431 (UMLS CUI [2,2])
C0369335 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
C0449575 (UMLS CUI [4,1])
C0524910 (UMLS CUI [4,2])
C0239946 (UMLS CUI [4,3])
C0919553 (UMLS CUI [4,4])
plasma hcv rna
Item
plasma hcv rna of 100,000 iu/ml
boolean
C0369335 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])
C0032105 (UMLS CUI [1,2])
HIV 1 and 2 antibody seronegative
Item
hiv 1 and hiv2 ab seronegative
boolean
C0919674 (UMLS CUI [1,1])
C0369497 (UMLS CUI [1,2])
C0919674 (UMLS CUI [2,1])
C1255639 (UMLS CUI [2,2])
C0369497 (UMLS CUI [1,2])
C0919674 (UMLS CUI [2,1])
C1255639 (UMLS CUI [2,2])
BMI
Item
body mass index (bmi) ≤ 35 kg/m2 bmi
boolean
C1305855 (UMLS CUI [1])
Untreated
Item
treatment naive subjects
boolean
C0332155 (UMLS CUI [1])
Contraindications to peginterferon or ribavirin therapy
Item
contraindications to peginterferon or ribavirin therapy
boolean
C0522473 (UMLS CUI [1,1])
C0982327 (UMLS CUI [1,2])
C0522473 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
C0982327 (UMLS CUI [1,2])
C0522473 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
Liver cirrhosis, decompensated liver disease (Child-Pugh)
Item
have evidence of liver cirrhosis, decompensated liver disease, and child-pugh score > 5
boolean
C0023890 (UMLS CUI [1])
C4075847 (UMLS CUI [2])
C4050412 (UMLS CUI [3])
C4075847 (UMLS CUI [2])
C4050412 (UMLS CUI [3])
Hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled diabetes
Item
have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled type i or ii diabetes
boolean
C0019045 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0029216 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0442867 (UMLS CUI [4,1])
C0205177 (UMLS CUI [4,2])
C0011849 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0018799 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0029216 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0442867 (UMLS CUI [4,1])
C0205177 (UMLS CUI [4,2])
C0011849 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])