ID

34323

Description

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

Keywords

  1. 1/16/19 1/16/19 -
  2. 10/7/20 10/7/20 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 16, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis C NCT00911963

Eligibility Hepatitis C NCT00911963

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects, 18-65 years of age (females non-child bearing potential in part b)
Description

ID.1

Data type

boolean

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)
Description

ID.2

Data type

boolean

plasma hcv rna of 100,000 iu/ml
Description

ID.3

Data type

boolean

hiv 1 and hiv2 ab seronegative
Description

ID.4

Data type

boolean

body mass index (bmi) ≤ 35 kg/m2 bmi
Description

ID.5

Data type

boolean

treatment naive subjects
Description

ID.6

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to peginterferon or ribavirin therapy
Description

ID.7

Data type

boolean

have evidence of liver cirrhosis, decompensated liver disease, and child-pugh score > 5
Description

ID.8

Data type

boolean

have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled type i or ii diabetes
Description

ID.9

Data type

boolean

Similar models

Eligibility Hepatitis C NCT00911963

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
male and female subjects, 18-65 years of age (females non-child bearing potential in part b)
boolean
ID.2
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
ID.3
Item
plasma hcv rna of 100,000 iu/ml
boolean
ID.4
Item
hiv 1 and hiv2 ab seronegative
boolean
ID.5
Item
body mass index (bmi) ≤ 35 kg/m2 bmi
boolean
ID.6
Item
treatment naive subjects
boolean
Item Group
C0680251 (UMLS CUI)
ID.7
Item
contraindications to peginterferon or ribavirin therapy
boolean
ID.8
Item
have evidence of liver cirrhosis, decompensated liver disease, and child-pugh score > 5
boolean
ID.9
Item
have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled type i or ii diabetes
boolean

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