ID

41435

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

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

see on clinicaltrials.gov

Uploaded on

October 7, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hepatitis C NCT00911963

English

Eligibility Hepatitis C NCT00911963

1 forms  
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

Age, Gender, non-child bearing potential

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0332197
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

HCV infection (anti-HCV-antibodies, HCV-RNA presence and histological evidence of chronic Hepatitis C)

Data type

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C0017431
UMLS CUI [3,1]
C0369335
UMLS CUI [3,2]
C0150312
UMLS CUI [4,1]
C0449575
UMLS CUI [4,2]
C0524910
UMLS CUI [4,3]
C0239946
UMLS CUI [4,4]
C0919553
plasma hcv rna of 100,000 iu/ml
Description

plasma hcv rna

Data type

boolean

Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
C0032105
hiv 1 and hiv2 ab seronegative
Description

HIV 1 and 2 antibody seronegative

Data type

boolean

Alias
UMLS CUI [1,1]
C0919674
UMLS CUI [1,2]
C0369497
UMLS CUI [2,1]
C0919674
UMLS CUI [2,2]
C1255639
body mass index (bmi) ≤ 35 kg/m2 bmi
Description

BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
treatment naive subjects
Description

Untreated

Data type

boolean

Alias
UMLS CUI [1]
C0332155
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to peginterferon or ribavirin therapy
Description

Contraindications to peginterferon or ribavirin therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0982327
UMLS CUI [2,1]
C0522473
UMLS CUI [2,2]
C0035525
have evidence of liver cirrhosis, decompensated liver disease, and child-pugh score > 5
Description

Liver cirrhosis, decompensated liver disease (Child-Pugh)

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C4075847
UMLS CUI [3]
C4050412
have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled type i or ii diabetes
Description

Hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0019045
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0029216
UMLS CUI [3,2]
C0262926
UMLS CUI [4,1]
C0442867
UMLS CUI [4,2]
C0205177
UMLS CUI [5,1]
C0011849
UMLS CUI [5,2]
C0205318
Back to the top of the page

Similar models

Eligibility Hepatitis C NCT00911963

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
plasma hcv rna
Item
plasma hcv rna of 100,000 iu/ml
boolean
C0369335 (UMLS CUI [1,1])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial